I-Corps for Novel Formulation Technology for Sustained Release Naloxone

PROJECT SUMMARY The proposed I-Corps project is based on a predicate SBIR Phase I award for the development of a long-lasting, sustained release of NLX product using a novel system of a pH/temperature-sensitive hydrogel embedded with NLX-encapsulated solid lipid nanoparticles (SLNs), employed in an in-situ gelling, subcutaneous injectable

formulation (1R43DA058477-01A1). The specific aims of this project are: Aim 1: Formulation and characterization of anionic NLX-loaded SLNs dispersed in a cationic temperature sensitive tri-block copolymer hydrogel system. Aim 2: Evaluating the in vivo efficacy of the hydrogel system in a fentanyl-induced rat model of opioid overdose.

In vivo studies under Milestone 2 aim to demonstrate that SLNs-loaded hydrogels can prevent fentanyl-induced respiratory depression and antinociception for up to 48 h following a single subcutaneous injection. The I-Corps team will be composed of Mr. Jeff Yang as the C-level Corporate Officer, Dr. Roman Domszy and

Dr. Barry Rhein as the Industry Experts, and Dr. Cesar Torres Luna as the Technical Lead. Mr. Yang is the CEO of Lynthera and has significant healthcare experience, including extensive fundraising relationships with healthcare investors (VC funds, family offices, private equity) through his previous career as a healthcare-

focused investment banker and private equity investor. Dr. Domszy is the R&D managing director of Lynthera and has more than 20-years of experience in the development of nanocomposite materials for industrial and biomedical applications. Dr. Domszy has served as the principal investigator on several NIH-funded SBIR grants

and is part of the senior/key personnel of the current SBIR. Mr. Barry Rhein is part of Lynthera's Scientific Advisory Board and currently provides the company with his extensive industry expertise with respect to commercialization and manufacturing of pharmaceutical products. Dr. Domszy and Mr. Rhein will be splitting

responsibilities for the Industry Expert role of the team to best meet the needs of this role and its time-intensive requirements. Dr. Torres Luna is a research scientist at Lynthera and the Principal Investigator of the current SBIR project. Dr. Torres Luna has a broad background in drug delivery, nanomedicine, polymer science,

nanotechnology, formulation development, and soft materials characterization.