FWBI stock gains as IND amendment for adrulipase is under FDA review (NASDAQ:FWBI)

Nano-cap biotech First Wave BioPharma (NASDAQ:FWBI) announced that its Investigational New Drug (IND) amendment for adrulipase targeted at the digestive disorder exocrine pancreatic insufficiency is currently under FDA review.

In November, the company announced the submission of an IND amendment to seek the FDA nod for a clinical trial to evaluate adrulipase as a treatment for EPI associated with cystic fibrosis (CF) and chronic pancreatitis (CP).

In a release late Friday, the company said that the filing is currently under the FDA review as an IND protocol amendment. The evaluation for Phase 2 protocols is expected to take 60 days or even longer subject to resource availability.

The discussions between the company and the FDA have been ongoing, and a decision is expected around the end of this month.

“Interactions with the FDA have thus far been supportive of our clinical plan, and we are working closely with our CRO partner and the clinical trial sites to begin enrolling patients as soon as we are able,” Chief Executive James Sapirstein remarked.

In November, First Wave (FWBI) said that a phase 2 trial for the candidate would get underway in early 2023 after FDA clearance of the IND request.