TASK ORDER AWARD. CHEMISTRY, MANUFACTURING AND CONTROLS AND RELATED SERVICES FOR DEVELOPMENT OF DRUG SUBSTANCES. 3 YEAR STABILITY STUDY EXTENSION ON THE L-ENK GMP BATCH (LOT 1000048945)

Investigators

Abstract

Leucine5-enkephalin (L-ENK), an endogenous opioid pentapeptide, is a natural pain killer, and functions as neurotransmitters/neuromodulators and inhibits neurotransmitters in the pathway for pain perception. In a collaboration between NCATS Therapeutics Development Brunch (TDB) and Virpax, L-ENK is being evaluated as a potential non-cancer pain regulator in a new novel formulation. NCATS TDB program is supporting preclinical and clinical development toward an Investigational New Drug (IND) application, including CMC development of L-ENK. of PTH-IA. A GMP batch (lot 1000048945) of LENK has been manufactured at Bachem and a portion of the batch has been qualified and used as a reference standard (Lot 1000066177) under an expired contract (HHSN271201700009I/ 75N95020F00002 with expiring date on 08/31/2024) and being used to support preclinical toxicology and incoming Phase I clinical studies. The contractor (Bachem) has reported 2-year stability study result on GMP material. Because of the slow progress on the formulation development of the project, the project team in TDB identified it is necessary to extend our current stability study on L-ENK (lot 1000048945) to 72 months to cover the estimated clinical trial period. L-ENK peptide structure: H-Tyr-Gly-Gly-Phe-Leu-OH The counter ion: Chloride Rare diseases