We are experienced. We are problem solvers.

At Arrivo, we strive to set a new standard in drug development that starts with the selection of drug candidates and runs throughout clinical development. Our approach and decision-making has delivered a history of excellent returns and product successes that makes us the trusted partner for industry and investors.

About Us

Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking out solutions for unmet medical needs. We strive to be the new standard for strategic asset selection and develop novel products through process that is both highly efficient and thoughtful.

Arrivo has built a portfolio of diverse late-stage drug candidates with the potential to be first-in-class or best-in-class. It is not just the products that are novel. Our entire approach is novel. Our unique form of drug development has resulted in a history of product successes and excellent returns.

The company stands on a solid foundation as our team has an average of more than 25 years of experience in drug development. We are propelled forward by our insatiable curiosity and drive to solve complex problems and help millions of patients globally.

Steve E. Butts

Steve is a co-founder and the CEO of Arrivo BioVentures, LLC, a drug development company.  He has over 25 years of experience in the pharma/biotech industry with and a track record of successful fund raising, product licensing and M&A with start-up companies.  Most recently, Steve was CEO of Velo Bio, a start-up company with a drug in development for severe preeclampsia.  Velo was sold to AMAG Pharmaceuticals in 2018.  Prior to Velo, he was co-founder, President and COO of Aerial BioPharma LLC, a drug development company that sold its lead drug for narcolepsy to Jazz Pharmaceuticals in 2014.  Prior to Aerial, Steve was co-founder and Executive Vice President of Neuronex Inc, acquired by Acorda Therapeutics in December 2012.  Additionally, he was an original member of the executive team at Addrenex Pharmaceuticals and played a key role in the company’s sale to Shionogi Pharma in 2009.  He has also served as Vice President of Sales & Marketing at BioBehavioral Diagnostics Company, as well as assignments at Eli Lilly and Company and Braintree Laboratories.

Steve is currently the Chairman of the Board of Directors of EnviCor Enterprises LLC, a plastics manufacturing company located in Smithfield, NC.  He is a member of the Board of Directors of Knopp Biosciences, a privately held pharmaceutical company. Steve is the Chair of the Board of Advisors of the Morehead Planetarium and Science Center at the University of North Carolina at Chapel Hill.

Steve holds a BS degree in Business Administration from the University of North Carolina at Chapel Hill and an MBA from the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill.

Michael F. AckermannMichael is the co-founder, COO, Business Development lead and Chief Operating Officer for Arrivo Management LLC. Michael is also the founder of Magnatas, LLC, which supports healthcare companies and venture firms in strategy development, business planning, organizational effectiveness, and process improvement. His clients have included Elan and Baxter as well as multiple start-up companies. In addition, he serves as the Managing Director of Solas BioVentures and is the co-founder and president of AB Collaborative Investments, an Angel Investment firm, which focuses on local and regional healthcare and IT start-ups.

Previously, Michael served as Senior Vice President for Global Commercial Solutions at Quintiles (IQVIA) leading the integration of clinical and commercial activities around pharmaceutical product development while guiding the Medical Communications Division through an organizational, operational and skill upgrade to significantly improve profitability and efficiency.

Prior to Quintiles, Michael spent more than 18 years at Eli Lilly and Company where he served as the leader of the US Neuroscience Business Unit. He grew revenue to over $4B and led the unit’s performance improvement, including the turnaround of major product, while overseeing two successful product launches. During his tenure at Lilly, he built and led sales organizations in both primary care and neuroscience. In addition, Michael held leadership positions in market research, global and US pricing and global health outcomes to support Lilly’s strategic initiatives.

Michael holds a BS degree in biology from Hampden-Sydney College in Virginia, a PhD in immunology from the Drexel University College of Medicine, and an MBA from the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill. In addition, he served as the Fogarty International Post-Doctoral Fellow at the National Institutes of Health/NIEHS where his research focus was in immunotoxicology and tumor immunology. He is a guest lecturer at the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill and the Kelly School of Business at Indiana University. Outside his professional activities, he enjoys spending time with his wife, five children and four grandchildren.

In addition, he enjoys volunteer work with his church and small start-up companies.

Karen AdamsKaren is the CFO of Arrivo BioVentures LLC.  She has over 35 years in a career as a finance professional working with companies across a broad range of industries with the last 20 years focused on life sciences and technology. After starting her career as an Internal Auditor with International Paper Company, Inc., Karen has held financial leadership positions with companies in the retail, software, professional services, manufacturing and biotechnology industries.

Prior to Arrivo BioVentures, Karen was the CFO for Aerial (asset acquired by Jazz Pharmaceuticals in 2014), Neuronex (acquired by Accorda Therapeutics in 2012), and Addrenex (acquired by Shionogi Pharma in 2009). While Karen’s life sciences experience has been primarily focused on early-stage, privately funded companies she was brought on as Assistant Controller at Millennium Pharmaceuticals, Inc. during its merger with COR Therapeutics – among the largest such mergers in the history of the biotech industry at that time. After Millennium Pharmaceuticals, Karen went on to work with several early stage biotechnology and medical device ventures including Micell Technologies, Bioptigen, Contego Medical, VeloBio, Midnight Pharm, Emergo Therapeutics and Target PharmaSolutions (now Target RWE).  Karen’s contributions were concentrated on the creation of dynamic, integrated financial forecasting models used for fund raising efforts and operational budgets as well as the implementation of core business structure and oversight of risk management activities. Karen graduated from Boston College earning a BS in Management, majoring in Finance.

Greg Rigdon

Dr. Greg Rigdon is Vice President of Scientific Affairs. Greg’s drug development experience includes discovery through phase 3 clinical trials and his regulatory experience includes IND and NDA filings. Prior to Arrivo, Greg served as Director of Clinical Research at Salix Inc., where he designed clinical trials and worked with regulatory authorities for multiple gastrointestinal indications as well as hereditary angioedema.

Greg was previously Vice President, New Product Development for Icagen, Inc, a small pharmaceutical company in Research Triangle Park, NC where he built and developed teams performing drug metabolism and pharmacokinetics, in vivo pharmacology, clinical research and toxicology.  Greg began his career in the pharmaceutical industry at Burroughs Wellcome (then Glaxo Wellcome) as a Wellcome Fellow, then Head of the Neuropharmacology Laboratory. He was project leader for antidepressant, central muscle relaxant and antipsychotic programs that resulted in IND filings.  Greg transitioned to clinical research and became International Product Development Team Leader for a new antiepileptic drug, managing a large international group of scientists from various disciplines including clinical pharmacology, toxicology, pharmaceutics and drug metabolism.

Greg has authored/co-authored over 30 journal articles in pharmacology, neuroscience and clinical research. He is also an inventor with 4 patents and has guest lectured at the University of North Carolina at Chapel Hill and Campbell University.  Greg earned his Ph.D. in Pharmacology from Texas Tech University Health Sciences Center in 1985.

Kelly Abernathy Kelly is the Vice President of Clinical Development.  Kelly has over 25 years of experience managing Phase I – IV clinical development programs in both adult and adolescent populations, with the majority of those programs involving products for the treatment of CNS diseases and disorders.  Prior to joining Arrivo, Kelly was the Director of Clinical Affairs at Aerial BioPharma, a successful drug development company that out-licensed its lead product for excessive daytime sleepiness in narcolepsy to Jazz Pharmaceuticals in 2014.  Kelly was previously the Manager of Clinical Affairs at Neuronex Pharmaceuticals, a specialty drug development company focused on developing treatments for patients with certain seizure disorders, acquired by Acorda Therapeutics in 2012.   In addition,  Kelly was an original member of the management team at Addrenex Pharmaceuticals, a pharmaceutical development company, sold to Shionogi Pharma in 2009.  While at Addrenex, Kelly managed the clinical program and NDA submission of the company’s lead product for ADHD.  Kelly was previously Section Head of Clinical Operations at Lineberry Research Associates, a contract research organization, where she managed clinical trials for a variety of pharmaceutical companies, from small start-up to large pharma, and provided line leadership to a department of clinical trial project managers and research associates.  Kelly graduated magna cum laude with a BS in biology, minoring in chemistry from Meredith College in Raleigh, NC.

Yuki Prescott

Yuki is the Director of Clinical Operations.  She has 19 years of experience managing and monitoring Phase I – III clinical development programs in adult populations, with the majority of those programs involving products for the treatment of CNS diseases and disorders.

Prior to Arrivo, Yuki was the Assistant Director of Clinical Affairs at Aerial BioPharma, a successful drug development company, where she oversaw the clinical development of multiple products, including the company’s lead product for narcolepsy, acquired by Jazz Pharmaceuticals in 2014.  Prior to that, Yuki was a member of the study management team for three large Phase III studies involving a product for the prevention of gastric ulcers while working as an independent consultant at Pozen. Yuki was also an original member of the clinical team at Addrenex Pharmaceuticals, a pharmaceutical development company, sold to Shionogi Pharma in 2009.  While at Addrenex, Yuki managed the clinical program of the company’s product for hypertension.  Yuki was previously a Project Manager at Lineberry Research Associates, a contract research organization, where she managed and monitored clinical trials for a variety of pharmaceutical companies.  Yuki earned a Master’s degree in Physical Therapy from East Carolina University in Greenville, NC, and a BA in Biology from Binghamton University in Binghamton, NY.

Dawn TalleyDawn is the Director of Operations.  She has over 30 years of experience supporting the start-up and management of clinical trials in the areas of CNS, Dermatology, Pain, Addiction and Cardiovascular.  She has negotiated well over 500 investigator and vendor contracts, assisted with site start-up and management, vendor management, FDA compliance and data integrity.   Dawn also has extensive experience with multiple start-up ventures, developing policies and procedures to ensure sustained growth of the company. Dawn’s previous responsibilities have included human resources management, facilities management, employee training and supervision.

Gema GomezGema is a Clinical Program Director, working on both the antibody programs for Arrivo.  Gema has been in the pharmaceutical industry for over 31 years, with more than 28 years of experience managing Phase I-IV clinical development programs in CNS, GI and infectious diseases.

Gema was previously the Clinical Development Manager at GSK responsible for leading the early clinical development programs of new epilepsy compounds as well as managing a number of post-marketing studies focused on side effects of anticonvulsants on women’s health. Gema managed the Clinical Innovation group at UCB and was responsible for finding and implementing new technology to both make clinical trials easier for patients and shorten the time from clinic to study results. In addition to managing clinical studies, Gema’s other job responsibilities have included training, process improvement and SOP development.

Gema earned her BA degree in Chemistry from Duke University.

Board of Managers

Steve E. Butts

Steve is a co-founder and the CEO of Arrivo BioVentures, LLC, a drug development company.  He has over 25 years of experience in the pharma/biotech industry with and a track record of successful fund raising, product licensing and M&A with start-up companies.  Most recently, Steve was CEO of Velo Bio, a start-up company with a drug in development for severe preeclampsia.  Velo was sold to AMAG Pharmaceuticals in 2018.  Prior to Velo, he was co-founder, President and COO of Aerial BioPharma LLC, a drug development company that sold its lead drug for narcolepsy to Jazz Pharmaceuticals in 2014.  Prior to Aerial, Steve was co-founder and Executive Vice President of Neuronex Inc, acquired by Acorda Therapeutics in December 2012.  Additionally, he was an original member of the executive team at Addrenex Pharmaceuticals and played a key role in the company’s sale to Shionogi Pharma in 2009.  He has also served as Vice President of Sales & Marketing at BioBehavioral Diagnostics Company, as well as assignments at Eli Lilly and Company and Braintree Laboratories.

Steve is currently the Chairman of the Board of Directors of EnviCor Enterprises LLC, a plastics manufacturing company located in Smithfield, NC.  He is a member of the Board of Directors of Knopp Biosciences, a privately held pharmaceutical company. Steve is the Chair of the Board of Advisors of the Morehead Planetarium and Science Center at the University of North Carolina at Chapel Hill.

Steve holds a BS degree in Business Administration from the University of North Carolina at Chapel Hill and an MBA from the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill.

Michael F. AckermannMichael is the co-founder, COO, Business Development lead and Chief Operating Officer for Arrivo Management LLC. Michael is also the founder of Magnatas, LLC, which supports healthcare companies and venture firms in strategy development, business planning, organizational effectiveness, and process improvement. His clients have included Elan and Baxter as well as multiple start-up companies. In addition, he serves as the Managing Director of Solas BioVentures and is the co-founder and president of AB Collaborative Investments, an Angel Investment firm, which focuses on local and regional healthcare and IT start-ups.

Previously, Michael served as Senior Vice President for Global Commercial Solutions at Quintiles (IQVIA) leading the integration of clinical and commercial activities around pharmaceutical product development while guiding the Medical Communications Division through an organizational, operational and skill upgrade to significantly improve profitability and efficiency.

Prior to Quintiles, Michael spent more than 18 years at Eli Lilly and Company where he served as the leader of the US Neuroscience Business Unit. He grew revenue to over $4B and led the unit’s performance improvement, including the turnaround of major product, while overseeing two successful product launches. During his tenure at Lilly, he built and led sales organizations in both primary care and neuroscience. In addition, Michael held leadership positions in market research, global and US pricing and global health outcomes to support Lilly’s strategic initiatives.

Michael holds a BS degree in biology from Hampden-Sydney College in Virginia, a PhD in immunology from the Drexel University College of Medicine, and an MBA from the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill. In addition, he served as the Fogarty International Post-Doctoral Fellow at the National Institutes of Health/NIEHS where his research focus was in immunotoxicology and tumor immunology. He is a guest lecturer at the Kenan-Flagler School of Business at the University of North Carolina at Chapel Hill and the Kelly School of Business at Indiana University. Outside his professional activities, he enjoys spending time with his wife, five children and four grandchildren.

In addition, he enjoys volunteer work with his church and small start-up companies.

Bruce currently serves as the President & CEO of Neurvati Neurosciences, a Blackstone Life Sciences company. He brings deep-rooted, wide-ranging experience to this role spanning clinical neuropsychiatry, biotechnology equity research, healthcare investment banking, and drug development. Across his many roles in academia, clinical medicine, financial services, and industry, Bruce has maintained a passion for knowledge and serving patients and families in need.

A physician by training and neuropsychiatrist by specialty, Bruce completed residency training in Neurology and Psychiatry at New York Presbyterian Hospital and Weill Cornell Medical College and is a Diplomate of the American Board of Psychiatry and Neurology. Bruce served as Director of Clinical Neuropsychiatry at Weill Cornell Medical College and maintains a voluntary faculty appointment in the Department of Psychiatry. Previously, Bruce was a Partner at PJT Partners where he provided M&A and capital markets advisory services to biotechnology companies. He also held roles in equity research and investment banking at Goldman Sachs and Credit Suisse, respectively.

Bruce is a Co-founder and Senior Advisor of Click Therapeutics, a biotechnology company developing software as prescription medical therapeutics. He serves as a member of the Scientific Advisory Committee for the Daedelus Fund for Innovation at Weill Cornell Medical College, as a member of the Life Science Institute Leadership Council and Michigan Drug Discovery Advisory Board at The University of Michigan, and as a Business Advisory Board member at FOXG1 Research Foundation.

Dave Co-Founded Solas BioVentures based upon the desire to bring much needed innovation to the patient’s bedside.   This patient centric focus came from his long academic medical career providing care and solutions to leverage the healthcare equation of Value = Quality /Cost.  He has operated a startup MedTech, co-founded a large regional medical specialty group, as well as grown angel investing into a full fledge venture fund targeting MedTech, pharma, diagnostics, and special healthcare situations.  Dave was the Southeast Medical Device Association member of the year in 2017.   He has served on Life Science Tennessee Association Board previously.   He is a widely published author with over 100 articles and a frequent speaker to academic venues throughout the U.S. and E.U.   He retired as professor emeritus from the University of Tennessee College of Medicine in the Department of Obstetrics and Gynecology. His prior board experience is notable for Veran Medical acquired by Olympus Medical, NxThera acquired by Boston Scientific, Aegea Medical acquired by Cooper Surgical, and Aerial BioPharma acquired by Jazz Pharmaceuticals.   Besides serving on the board of Arrivo BioPharma he serves on Veranex Solutions, Francis Medical, Knopp BioSciences, Intershunt Technologies, and Vesalio.

Dave earned a BS in Biology from Morehead State University, a MD from The Joan C Edwards School of Medicine of Marshall University, Residency in Obstetrics & Gynecology from The University of Florida, Maternal Fetal Medicine from Wake Forest University, and an MBA from The Gary W. Rollins College of Business of The University of Tennessee Chattanooga.

Chris is the Head of Corporate Development at Jazz Pharmaceuticals, where he has been a member of the Corporate Development team since 2012 and has worked on over $10B in total transactions across neuroscience and oncology during his time there. Prior to Jazz, he worked in a variety of operational roles at Azur Pharma and started his career at Deloitte, focused on life science and non-profit clients. Chris holds a bachelor’s degrees in accounting and finance from The Ohio State University.

Therapeutic Areas

Our model allows the company to look for potential products that offer improvements in patient care across many different therapeutic areas. We can be opportunistic, and not tied to a particular disease or disorder, because we do not have to worry about the product fitting into our commercial infrastructure. Instead, we find the right commercial partner for each individual product. The flexibility has enabled us to build a pipeline of diverse assets with a common theme, all of our programs address unmet medical needs of patients and all have the potential to be first-in-class or best-in-class.

Pipeline

MAJOR DEPRESSIVE DISORDER

Major depressive disorder (MDD) is a substantial health burden worldwide and is characterized by single or recurrent major depressive episodes. Like other neuropsychiatric disorders, depression has a varied etiology, including genetic, epigenetic, and environmental factors. The most prevalent environmental factor is stress. MDD can be spontaneous, but it often follows a traumatic emotional experience, or it can be a symptom of other conditions, most often neurological (stroke, multiple sclerosis, or Parkinson’s disease) or endocrine. MDD has also been linked to cardiovascular disease, diabetes, asthma, obesity, and several adverse health behaviors.

MDD is associated with considerable morbidity and mortality. For many patients, an initial episode of depression evolves into a recurrent and debilitating chronic illness with significant and pervasive impairments in psychosocial functioning. According to the National Institute of Mental Health an estimated 16.1 million adults aged 18 or older in the United States had at least one major depressive episode in 2015.  This number represented 6.7% of all U.S. adults.

Despite a multitude of available antidepressants available today, it is estimated that 50% of the patient will not respond to their first therapy and 35% will not recover functionally.  So, the opportunity exists for antidepressants with a new mechanism of action to achieve a faster onset of action, better efficacy, less side effects, or effectiveness in subpopulations.

SP-624 is a small molecule with an undisclosed novel mechanism of action that is currently assessed in a phase II study for its effectiveness in treating patients with major depression.  While SP-624 has no effects on multiple receptors (including glutamate receptors), channels and transporters, it does activate presynaptic nerve terminals and postsynaptic neurons.  In addition, neuronal connectivity, glutamatergic neuronal function and enhanced Long-term Potentiation in the hippocampus may also contribute to the antidepressant effect. SP-624 will represent a new approach to treating overall depression as well as some subpopulations currently underserved.

PLAQUE PSORIASIS

Plaque psoriasis is a common and incurable chronic immune-mediated skin disease characterized by red and flaky patches that are itchy and can be painful during flareups which can last for several weeks to months (Mayo Clinic, 2020). It is the most common form of psoriasis, affecting between 80% and 90% of individuals living with psoriasis, and can occur on any area of the body such as the scalp, hands, and feet (National Psoriasis Foundation, 2018). The disease rarely is life threatening but often is intractable to treatment, with relapses occurring in most patients.

Several risk factors for developing psoriasis and its severity have been identified and can be intrinsic (i.e., family history, stress) or extrinsic (i.e., smoking). Comorbidities associated with plaque psoriasis patients include depression, cardiovascular disease, inflammatory bowel disease, and psoriatic arthritis.

Disease severity is defined by the percentage of the body affected by plaques, with mild disease having less than 3%, moderate disease 3-10% and severe > 10% of the body affected. However, hard to treat plaques can occur in all patients.

Many treatments exist for psoriasis. Three basic treatment modalities are available for the overall management of psoriasis: topical agents; phototherapy; and systemic agents, including biologic therapies. Plaque psoriasis appears to respond better to combination topical/systemic therapy than to systemic treatment alone.

For decades Tumor necrosis factor (TNF)-α inhibitors have been a mainstay of systemic plaque psoriasis therapy for over a decade.  DLX-105 will be the first TNF-alpha inhibitor administered intradermally directly onto treatment resistant plaques. Activity from DLX-105 is restricted to the plaque site without affecting systemic immunity. It is the novel method of self-administration through micro needles that makes this local effect possible (see the illustrations below).

Feedback from psoriasis patients who tested placebo patches on psoriasis plaques indicates that the application was very well tolerated.  The company is currently preparing for an open label phase II study in patients with mild to moderate plaque psoriasis.

INFLAMMATION

Inflammation is a critical response to potential external and internal danger signals and damage in organs. The inflammatory process can take two basic forms, acute and chronic. Acute inflammation is the body’s immediate response to injury and helps to prevent further injury while facilitating the healing and recovery process.

Chronic inflammation may last beyond the actual injury, sometimes for months or even years. It can become a problem itself and require medical intervention to control or stop further inflammation-mediated damage. Chronic inflammatory diseases contribute to more than half of deaths worldwide (Nature Medicine 2019; 25(12):1822–1832).

The immune response occurs in two overlapping stages.  The innate immune response represents a first line response to antigens mediated by macrophages, natural killer cells, and dendritic cells.  These cells also produce cytokines such as IL-1 and IL-6 that are the main drivers of inflammation.

Inflammation is associated with diseases in several therapeutic categories such as:

  • Oncology
  • Cardiology
  • Metabolic Disorders
  • Pulmonary Diseases
  • Psychiatric and neurodegenerative Disorders
  • Infectious Disease (ARDS)
  • Rheumatology
  • Gastroenterology

Interleukin-1β (IL-1β) is a master cytokine of local and systemic inflammation and part of the innate immune system. It is activated as part of the innate immune response by inflammasomes and caspase-1 and plays a pathogenic role in acute and chronic inflammatory diseases.

DLX-2323 is a potent, selective single chain variable antibody fragment (scFv) against IL-1β. Due to its small size it has excellent tissue penetration and can be administered via multiple routes of administration.  Given the increasing prominence and understanding of inflammation in various diseases and disorders and the role of IL-1β, DLX-2323 has the potential to neutralize systemic and local IL-1β.

SEVERE ACUTE PANCREATITIS

Acute pancreatitis is a serious condition that results in 250,000 hospital admissions per year in the US alone, with incidence rates rising rapidly in recent years driven by factors such as diet and increasing obesity rates. Because of the lack of an effective therapy, this can often result in a life-threatening debilitating illness, secondary complications, extended hospitalization, high medical bills, and severe life and family disruption. An estimated 15-25% will develop severe acute pancreatitis defined by prolonged organ failure. Overall, morality is about 5% and costs $2.6 billion in inpatient medical care costs annually.
Acute pancreatitis is one of the core areas of interest for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and is particularly relevant given the serious burden of this disease on affected patients and the health care system.
Pancreatic lipases are naturally occurring enzymes found in the stomach and pancreatic juice. Their function is to digest fats and lipids and help maintain correct gallbladder function. In acute severe pancreatitis, lipases are leaked by the inflamed pancreas, which then damage the surrounding fat.

RABI-767 is a small molecule lipase inhibitor that has shown profound efficacy in the treatment of acute pancreatitis in multiple clinically relevant mouse models. Our development program will build on the groundbreaking discovery that lipase inhibition is able to prevent the serious and debilitating systemic toxicity and organ failure associated with severe acute pancreatitis.

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