Development of a systems pharmacology agent for treatment of bronchopulmonary dysplasia

ReNeuroGen LLC is seeking a $50,000 TABA NHLBI SBIR administrative supplement to support regulatory planning and engagement with the FDA for our therapeutic development program targeting Bronchopulmonary Dysplasia (BPD). This request is submitted under PA-20-272 to supplement our existing NHLBI-funded Direct- to-Phase II SBIR grant R44HL166018 entitled “Development of a systems pharmacology agent for treatment of bronchopulmonary dysplasia.” Our novel drug candidate, N-acetyl-lysyltyrosylcysteine amide (KYC), is an end- capped tripeptide/small molecule that is a first-in-class systems pharmacology drug with demonstrated efficacy in both rat and rabbit models of BPD. ReNeuroGen operates as a virtual pharmaceutical company (vPharma), a strategic model outlined in detail in our original Phase II SBIR Commercialization Plan. This model emphasizes lean infrastructure and the targeted use of specialized external expertise. Accordingly, to de-risk the KYC program and define a clear regulatory path to IND filing, we are seeking support to engage RareMoon Consulting—a regulatory advisory firm with a strong track record in pediatric and orphan drug development, including FDA pre-IND meeting preparation and IND submission strategy.