NicOx partner Topigen starts Ph II with TPI-1020

Sophia Antipolis, France-based NicOx SA says that its partner, Topigen Pharmaceuticals, has initiated a Phase II clinical development program for TPI-1020 (formerly NCX 1020) in respiratory disorders. Topigen aims to develop TPI-1020 as a treatment for chronic obstructive pulmonary disease, which could be more effective than conventional corticosteroids. TPI-1020 is a novel, inhaled, nitric oxide (NO)-donating derivative of budesonide, for which Topigen licensed North American rights and an option on worldwide rights from NicOx in 2005.

The first Phase II study initiated by Topigen has the primary objective of assessing the general safety, tolerability and pharmacodynamic activity of inhaled TPI-1020 in smokers with asthma, and is expected to be followed by a subsequent trial in COPD. This first trial in asthmatic smokers is a 21-day, multicenter, randomized, double-blind study, which will evaluate repeated and ascending doses of either TPI-1020 or budesonide in two treatment groups of 15 subjects per group. Secondary objectives will assess preliminary efficacy measurements.