AGI finalizing US NDA plan for arverapamil

Dublin, Ireland-based AGI Therapeutics has issued an update on its key development programs. Following on from the reporting of clinical results on four of its products last year and the recent reporting, earlier this month, of data on two other products, AGI says it can now map out the next key steps in progressing five of the original six products in its pipeline into further clinical development.

AGI says it has requested a meeting with the US Food and Drug Administration to define and agree the full development strategy for its lead product candidate, arverapamil (AGI-003), required to support a New Drug Application submission for irritable bowel syndrome. The firm expects to provide guidance on the overall development plan for this product in the second quarter, noting that it has completed the manufacturing of the drug substance to support anticipated further development requirements and entered into a manufacturing agreement with an FDA-approved enterprise to supply the product for the next phase of clinical testing.

The firm has also initiated a Phase II combined pharmacokinetics and pharmacodynamics study of its controlled-release omeprazole (AGI-010) product for gastro-esophageal reflux disease with its partner Axcan Pharma, and expects to report results in the second quarter, while 4-ASA (AGI-004) will advance into a Phase II trial for ulcerative colitis, the design of which is currently being finalized.