Plans for Phase 3 smoking cessation trial underway

Drug development company Invion (ASX:IVX) has met with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) of the US Food and Drug Administration (FDA) to discuss Phase 3 plans for development of oral INV102 (nadolol) as a treatment for patients with chronic obstructive pulmonary disease (COPD) who cannot quit cigarette smoking.

INV102 is a beta adrenergic-biased ligand targeted to reverse mucous metaplasia in the airway epithelium to treat chronic inflammatory airway diseases. Invion last year reported that a 155-patient phase 2 study of oral INV102 in smoking cessation demonstrated good safety and that treated patients were more likely to stop smoking completely or dramatically reduce the number of cigarettes smoked.

According to Invion, written and oral communication with the FDA fully supports Invion’s proposals for further manufacturing in conjunction with Phase 3 development. The company and the FDA have engaged in a productive dialogue on the design and regulatory target of the Phase 3 plan for oral INV102.

“We are pleased that the FDA has confirmed our plans for INV102 as a treatment for patients with established chronic bronchitis who cannot quit smoking due to increased cough and sputum production,” said Invion Executive Vice President R&D and Chief Medical Officer Dr Mitchell Glass.

“Our discussion, based on their in-depth review, reflected their deep interest in our program and their shared desire to see us succeed in enabling these patients to quit by ameliorating symptoms that have precluded previous quit attempts.

“We welcome their recommendations, which will focus and strengthen our registration program without causing delay.”

Invion (ASX:IVX) shares were trading 20% higher at $0.006 as of around 11 am on Monday.