BIO-Europe Spring Presenting Companies 2023
Alphyn Biologics, Inc.
Alphyn is a novel biotherapeutics company operated by experienced large pharmaceutical company and entrepreneurial industry scientists and business executives. It has a pipeline of new drug products based on its AB-101 Active Pharmaceutical Ingredient (API) platform, developing well validated products focused on the $40B inflammatory and rare diseases of the skin. AB-101 is a unique API with multiple bioactive compounds, therefore multiple mechanisms and action and therefore multiple ways to attack and treat each target disease. Due to its chemical nature and strong safety and side effect profile, drug products based on Alphyn’s AB-101 API have patient use and regulatory approval advantages in cost and speed to approval as evidenced by Alphyn’s lead product receiving a waiver for the Phase 1 clinical trial going straight to the Phase 2 clinical trial. Alphyn has a way forward to 10 years USA FDA exclusivity for its lead product targeted to treat Atopic Dermatitis (AD) through FDA New Chemical Entity status and QIDP designation. The company has raised to date USD 7.1 million in 3 rounds of funding. It has an impressive patent application portfolio with 21 patent applications filed. Alphyn has completed enrollment in its Phase 2a clinical trial in non-infected AD. This trial achieved all endpoints. Alphyn is at the midpoint in participant enrollment for its second Phase 2a clinical trial uniquely assessing AD with secondary infection.