SALISBURY, Md.--(BUSINESS WIRE)--#BioTech--Akyso Therapeutics, a privately held biotechnology company developing long-acting subcutaneous drug delivery systems, today announced two major milestones: (1) the successful completion of its first-in-human Phase 1a clinical trial of iSTEP-N®, a bioabsorbable extended-release naltrexone implant for opioid use disorder (OUD) engineered to delivery naltrexone for 12 months following a single, simple, in office treatment, and (2) the receipt of $15 million in federal funding from the National Institute on Drug Abuse (NIDA) to develop a parallel12 month buprenorphine-based implant (iSTEP-B®) for OUD.
Key Highlights:
- Phase 1a trial demonstrated that the iSTEP-N® implant was well-tolerated with no serious adverse events or implant-related complications.
- Sustained therapeutic plasma levels of naltrexone were observed for three months following a single implant.
- Residual Naltrexone content of the implant after 3-months suggests potential for 12-month efficacy.
- The iSTEP® platform utilizes a proprietary, fully bioabsorbable polymer system that does not require surgical removal.
- A Phase 1b study in patients with OUD is planned for early 2026 and will include a comparison to Vivitrol®.
- $15 million NIDA grant awarded for the development of a 6-12-month extended-release buprenorphine implant, iSTEP-B®.
“We are thrilled to share not only the success of our Phase 1a iSTEP-N® trial, but also the launch of our buprenorphine implant program with support from NIDA,” said Steven Cohen, MD, FACS, co-founder and co-CEO of Akyso Therapeutics. “This expanded funding and validation from the NIH will allow us to pursue our dual-track approach to transforming OUD treatment with both naltrexone and buprenorphine.”
Naltrexone and buprenorphine formulations represent over 90 percent of treatment options for OUD in the United States. The iSTEP products represent disruptive ultra long acting formulations of both naltrexone and buprenorphine and with them Akyso Therapeutics is poised to capture a large portion of the $3B OUD treatment market in the US. The new buprenorphine implant project builds directly upon Akyso’s iSTEP® platform. iSTEP-B® will use the same bioabsorbable, subcutaneous delivery system as iSTEP-N®, with the goal of delivering therapeutic buprenorphine levels continuously for more than six months. The company plans to follow a similar clinical development pathway, including formulation, CMC analytics, GLP toxicology, and human trials.
“Our goal is to offer patients long-acting, discreet treatments that reduce relapse risk during the most vulnerable stages of recovery,” said Jeffrey Benner, MD, co-founder and co-CEO. “With iSTEP-N® entering patient trials and iSTEP-B® now funded for development, we are well-positioned to provide scalable, very long acting, implantable therapies for both opioid and alcohol use disorders.”
Akyso’s iSTEP-N® program is supported in part by NIDA (UH3DA048338). A description of the Phase 1a trial is available on ClinicalTrials.gov under the identifier NCT06053197. The new iSTEP-B® buprenorphine program is supported by a separate $15 million federal grant (2025–2029).
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Contacts
Media Contact:
Akyso Therapeutics
26627 Pemberton Drive, Salisbury, MD 21801
(727)270-0659
www.akyso.com
