The Implantable, Subcutaneous, Tunable, Extended-release, Polymeric implant ISTEPTM) is our proprietary formulation that allows safe and effective extended-release drug delivery for six to twelve months. Our implants are optimized to be inserted subcutaneously in the office through a small incision. The proprietary iSTEP platform technology allows excellent API loading into a tunable release system which can be safely delivered to the subcutaneous space to deliver pharmaceutical agents that would otherwise have to be injected. The six-month duration of our drug delivery system makes it an excellent choice for pharmaceutical agents where compliance is a problem.
Patent numbers 9,452,083, 9,445,941, and 11,197,819.
The subcutaneous naltrexone implant, the iSTEP-N®, is Aksyo's beachhead product. Our phase 1 clinical trial of the iSTEP-N® will be recruiting patients shortly and is listed on clinicaltrials.gov. (For research and development purposes the naltrexone implant is called the BIOPIN 6.)
Release rate of any small molecule API can be adjusted by adjusting the ratio of the control release polymers in the formulation. This allows for optimization of the pharmacokinetics for effective drug delivery. The implant is sturdy and can be manufactured in any size. It is stable at room temperature.
The non-reactive biocompatible material can be loaded with any medication. The two control release polymers have been used in FDA approved devices for decades and are well tolerated.
Our device is designed for easy subcutaneous implantation. The implant comes loaded with drug ready to use. It is Bioabsorbable and does NOT need to be removed.
Akyso Therapeutics is a pharmaceutical company which has been working in sustained release drug delivery since 2014. It's beachhead product currently under development is the Implantable Subcutaneous Tunable Extended-release Polymeric implant containing Naltrexone (iSTEP-N®).
The opioid crisis rose to prominence at a shocking rate. And the trail of destruction left in its wake has damaged relationships, families, and communities. With more than 100,000 Americans dying from drug overdoses and 7 million struggling with opioid addiction, there is no time to lose in addressing this epidemic. We need to take an honest look at how we got to this point and what we can do to stop it.
Jennifer Sharpe Potter, Ph.D., M.P.H., is Professor in the Department of Psychiatry and Vice Dean for Research at the Joe R. and Teresa Lozano Long School of Medicine at UT Health San Antonio.
In April 2019, we were awarded a grant from the National Institute of Drug Abuse (NIDA) at the National Institute of Health (NIH).
This funding is to help with the cost of developing our six-month, subcutaneous, sustained-release naltrexone implant for opioid use disorder.
Financial conflict of interest disclosure is important to research integrity because it helps prevent research from being biased or influenced by personal or financial interests. Our policy regarding finanical conflicts of interest is available here
.Our research and development team has developed the ISTEP technology; a safe and effective implant capable of significantly prolonging the effect of systemic pharmaceuticals.
Our proprietary formulation using control release polymers and naltrexone has been shown safe in IND enabling toxicology studies and biocompatibility studies.
In vitro studies have shown excellent tunable release from our formulation.
In Vivo studies in large and small animals have demonstrated excellent release kinetics from the implant with no evidence of toxicity.
Our team has extensive experience on in vitro and in vivo studies as well as surgery and instrument design.
Jeffrey D. Benner, MD, is a physician-entrepreneur and former retina surgeon who transitioned to addiction medicine to address the urgent needs of the opioid crisis. He is the co-founder and co-CEO of Drug Delivery Company (Akyso Pharmaceuticals), where he leads the development of BIOPIN—a bioabsorbable, extended-release naltrexone implant for opioid use disorder. Dr. Benner has secured over $13 million in NIH funding as co-principal investigator and holds numerous patents related to long-acting drug delivery systems. His innovations aim to improve treatment adherence and accessibility, particularly during early recovery from opioid use disorder. He is also the founder of Delmarva Hemp, which developed a patented, solvent-free method for full-spectrum cannabinoid extraction and is pursuing FDA approval of its Viva CBD product as a non-addictive comfort medication for opioid withdrawal.
Steven M. Cohen, MD, is a board-certified retina surgeon, inventor, and Clinical Professor of Ophthalmology at the University of South Florida. A graduate of Harvard College and Harvard Medical School’s HST program, he co-founded Drug Delivery Company (Akyso Pharmaceuticals) with Dr. Jeffrey Benner in 2014 to develop long-acting subcutaneous implants for chronic diseases. As co-CEO and co-PI, Dr. Cohen has helped guide the BIOPIN naltrexone implant through preclinical studies and into human trials with support from NIDA. He holds multiple U.S. patents and has served as a principal or sub-investigator on over 100 FDA registration trials. Drawing from his personal and professional experience with addiction and implantable therapeutics, Dr. Cohen brings a unique perspective to designing patient-centered drug delivery systems that combine scientific rigor with practical usability.
Jonathan D. Berman, MD, PhD, is a physician-scientist and global drug development expert with over four decades of experience in infectious disease research and clinical trials. A graduate of Williams College, Harvard University, and the Albert Einstein College of Medicine, Dr. Berman has led numerous international programs in translational medicine, including key roles at the Walter Reed Army Institute of Research, the NIH, and the World Health Organization’s Tropical Disease Research (TDR) initiative. As Senior Vice President for Clinical Affairs at Fast-Track Drugs and Biologics, he has served as clinical or efficacy lead on multiple FDA-approved new drug applications, including miltefosine for leishmaniasis, tafenoquine for malaria prophylaxis, and IV artesunate for severe malaria. Dr. Berman is the author of over 60 scientific publications and continues to advise on regulatory strategy and clinical trial design for innovative therapies.
Pravin Soni, PhD, is a veteran pharmaceutical development expert with over four decades of experience in drug, device, and combination product innovation. He holds a PhD in Macromolecular Science and Engineering from Case Western Reserve University and a B.Tech. in Chemical Engineering from LIT, Nagpur. Dr. Soni is President of PharmaCRO, LLC, a consultancy specializing in CMC and IP strategy. He has held senior leadership roles at Respivant Sciences, Patara Pharmaceuticals, Elevation Pharmaceuticals, Alexza Pharmaceuticals, and Cygnus Inc., where he led the development of groundbreaking drug delivery technologies—including inhalers, transdermal systems, and continuous glucose monitoring. He is an inventor on more than 60 U.S. and international patents and has contributed extensively to the scientific literature in pharmaceutical formulation and device engineering.
Adrienne O’Reilly, MS, CQA, is a seasoned quality and regulatory expert specializing in pharmaceutical, biotech, and combination product development. With over a decade of experience building and leading phase-appropriate, inspection-ready quality systems, she has held leadership roles at companies including Immunovant, Respivant, Savara, and Xeris, where she played a pivotal role in preparing products for Phase III trials and regulatory approval. Currently Head of Quality at QbDVision, she oversees compliance, validation, and continuous improvement of a GAMP5-compliant digital quality platform. Ms. O’Reilly is a Certified Quality Auditor and an expert in FDA and EMA regulatory expectations, computer system validation, and quality system implementation. Her work spans drug-device design control, GMP compliance, and eQMS integration, and she has successfully supported products through preclinical, clinical, and commercial development stages.
We are excited about this promising treatment for opioid use disorder!
Akyso Therapeutics
26627 Pemberton Drive
Salisbury, MD 21801