Akyso Therapeutics, LLC

Development of a Bioabsorbable, Subcutaneous, Extended-release Buprenorphine Implant for Opioid Use Disorder - Project Summary/abstract the Drug Delivery Company (DDC) Is Developing a Bio Absorbable, Extended-release Buprenorphine Implant. It Is Intended to Help Address the Challenges Posed by Opioid Use Disorder (OUD) and the Fentanyl Overdose Crisis. Currently, the Longest-lasting Formulation of Buprenorphine (BUP) Is a One-month Long-acting Injection (sublocade ® and Brixadi ®). an Extended-release Buprenorphine (xr-bup) Implant, Capable of Releasing Therapeutic Levels of Bup for Over 6 Months, Will Improve Medication Compliance and Provide a New Treatment Option for Patients and Healthcare Providers. in Collaboration With the National Institute on Drug Abuse (nida), DDC Has Been Actively Involved in Developing a Subcutaneous, Bioabsorbable, Extended-release 6-MONTH Naltrexone (NTX) Implant Since 2019. Building Upon the Success of the 6-MONTH Bioabsorbable Naltrexone Implant, Known as the Istep-n®, DDC Is Now Creating a 6-MONTH Bioabsorbable Buprenorphine Implant Using the Same Technology. the Istep-n® Utilizes a Patented Bioabsorbable Drug Delivery Platform, Which Is Protected by U.s. Patent No. 11,197,819. in Pre-clinical Studies, the Istep-n® Implants Demonstrated the Release of Therapeutic Plasma Levels of NTX for Over 7 Months in Canines With a Mean Plasma Concentration of 5.3 NG/ML, With Detectable Levels Persisting for More Than 8 Months. the Istep-n® Was Well-tolerated, and No Adverse Events Were Reported. the Fda Granted an Investigational New Drug (IND) Approval Without Clinical Hold [ind 152127] for the Istep-n®, Allowing the Company to Commence a Phase I Clinical Trial in Healthy Volunteers (Q2 of 2024). the Development Plan for the Xr-bup Implant (istep-b) Will Be to Follow the Roadmap That Was Used for the Istep-n® Naltrexone Implant. the Chemical Similarities Between NTX and Bup Allow for the Loading of Bup Into the Istep-n® Drug Delivery Platform. This Study Is Targeting the Same Plasma Concentration for Both the NTX and Bup Implants, Which Is > 2-4 NG/ML Throughout the Entire 6-MONTH Duration of the Implant. at This Stage, There Should Only Be Minor Adjustments Made to the Methodology Used in Developing the Istep-n® Naltrexone Implant. the Development Process for the Bio Absorbable, Extended-release Buprenorphine Implant Will Follow the Same Pathway, Including Implant Formulation, Chemistry, Manufacturing, and Controls (CMC) Analytics, Non-glp Animal Studies, GLP Ind-enabling Toxicology Studies in Rodents and Canines, Submission of the Ind Application to the Fda, and Ultimately the Completion of Phase I and Phase Ii Clinical Trials. the Effectiveness of a 6-MONTH Buprenorphine Implant Is Expected to Provide Stability and Support for Oud Patients During Those Critical Initial Six Months of Recovery. Subsequently, With Only Two Annual Office Visits Required for a New Xr-bup Implant, Patients Can Focus on Psychosocial Therapy, Recovery, and Rebuilding Their Lives. an Xr-bup Implant, Releasing Therapeutic Buprenorphine for Over 6 Months, Will Enhance Medication Compliance and Offers a Fresh Solution to Opioid Use Disorder and the Fentanyl Overdose Crisis.