PharmaDrug Inc. has announced the successful completion of a stability study for its patented enteric-coated cepharanthine formulation, PD-001. This milestone supports the manufacturing of clinical trial material for a first-in-human Phase 1 clinical study evaluating PD-001 as a potential treatment for viral infectious diseases. The study, approved by the Australian Human Research Ethics Committee, is set to commence in Australia.
Stability Study Details
The six-month accelerated condition stability study (40 degrees Celsius and 75% relative humidity) was conducted by Genvion Corporation. Results indicated acceptable change for all measured parameters, confirming the stability of PD-001 as an active ingredient in both bottled and encapsulated forms. Genvion Corporation will now proceed with manufacturing PD-001 clinical trial material for the upcoming Phase 1 study.
Robert Steen, CEO of PharmaDrug, stated, "The stability study gives us the confidence that our manufacturing strategy is appropriate to move forward with scale up and GMP activities to support clinical trials. With the study now complete, we can finally look to finalize plans to begin our phase 1 study in Australia."
About PD-001
Cepharanthine, a natural product used for over 70 years in Japan, has demonstrated anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic properties in clinical research. PD-001 is a reformulated version of cepharanthine designed to improve oral bioavailability, which has historically been a limitation of the drug. Preclinical studies in rodent and non-rodent models have shown that PD-001 possesses markedly improved oral bioavailability compared to generic cepharanthine, potentially eliminating the need for frequent intravenous administration.
PD-001 is protected by US Patent US10576077, with a patent expiration date of March 23, 2036. Sairiyo Therapeutics aims to develop an efficacious oral therapeutic to potentially improve outcomes for infectious disease and oncology applications.
