NicOx S.A. partner, Topigen Pharmaceuticals, Inc., initiates phase 2 development programme for TPI-1020 (formerly NCX 1020) in respiratory disorders. Topigen aims to develop TPI-1020 as a treatment for chronic obstructive pulmonary disease (COPD), 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 2 clinical trial 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, multi-centre, 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.

Damian Marron, VP of corporate development at NicOx commented, "We are very pleased to have entrusted the development of TPI-1020 to Topigen, who have a strong expertise in the respiratory area and are clearly resolved to execute on the aggressive clinical plan they have designed. This progress validates NicOx' continued strategy of signing research and development partnerships on its NO-donating compounds in non-core therapeutic areas."

TPI-1020 has been shown to be more effective than budesonide at blocking the recruitment of inflammatory cells (neutrophils) in rodent models of airway inflammation and pulmonary disease. Neutrophils are immune cells that play a central role in the pathology and exacerbations of COPD.

NicOx is targeting the therapeutic areas of inflammatory and cardio-metabolic diseases. Resources are focused on two lead compounds, HCT 3012, in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for Peripheral Arterial Obstructive Disease (PAOD). NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.

"TPI-1020 is part of an exciting new class of nitric oxide (NO)-donating therapeutics, and it targets the underlying inflammation involved in certain lung disorders," said Dr. Louise Proulx, VP of product development at Topigen. "Our preclinical and clinical observations suggest that the drug has broad potential to provide effective therapy for airway diseases, such as COPD and certain asthma indications. The goal of our program is to develop a medication that inhibits the recruitment of inflammatory cells or neutrophils and is more effective than leading conventional corticosteroids in treating patients with COPD," he added.