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 is a pharma 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 cofounder and CEO of the Akyso. He is a practicing physician and retinal specialist ophthalmologist who has been practicing at the Retina Consultants of Delmarva in Salisbury, MD since 1993. He is a graduate of the University of Maryland School of Medicine. He is an inventor who holds 9 patents.
Steven Cohen, MD graduated with honors from Harvard College in Mathematics and completed his medical training at Harvard Medical School in the Harvard-MIT Health Sciences and Technology Program. He did an internship at Brown University and an Ophthalmology residency at University of California, Davis. He then completed two years of Retina fellowship training at the Bascom Palmer Eye Institute at the University of Miami. Dr. Cohen is a Clinical Professor of Ophthalmology at the University of South Florida School of Medicine.
Dr. Cohen has over 60 published papers and abstracts in peer reviewed journals. He has spoken at national and international Retina meetings. He is board certified by the American Board of Ophthalmology. He is a fellow of the American Academy of Ophthalmology. He is an inventor who holds 7 patents.
We are excited about this promising treatment for opioid use disorder!
Akyso Pharmaceuticals
26627 Pemberton Drive
Salisbury, MD 21801