Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF), the clinical-stage biopharmaceutical company, has received positive feedback from the US Food and Drug Administration (FDA) in a pre-investigational new drug (IND) meeting for its lead asset POLB 001.
POLB 001 is being developed as a potential preventative therapy for cytokine release syndrome (CRS), a serious side effect triggered by cancer immunotherapy treatments.
The FDA's feedback was broadly in line with key aspects of Poolbeg's proposed development strategy for the drug candidate, including agreement on the primary endpoint for a future phase III clinical trial.
A pre-IND meeting allows pharmaceutical companies to present their clinical development plans and receive regulatory guidance before formally submitting an application to begin human trials in the US.
Poolbeg said the broad agreement with the FDA on the development pathway represents an important milestone that provides potential partners with greater certainty on the route to market, further de-risking the programme.
The company, which has a core focus on cancer immunotherapy, believes there is an attractive route to market for POLB 001 and that the FDA feedback reaffirmed the appeal of the programme to potential licensing or development partners.
Bruno Speder, vice president of regulatory affairs at Poolbeg, said the company achieved broad alignment on several important aspects of the development pathway and that the feedback supports ongoing partnering discussions.