NicOx SA announced the results of a phase-2a study for TPI 1020, conducted in 62 patients with Chronic Obstructive Pulmonary Disease (COPD) by its partner Topigen Pharmaceuticals Inc. TPI 1020 showed good overall safety and tolerability, although its activity profile was not significantly different from budesonide, a conventional corticosteroid commonly used in respiratory disorders. TPI 1020 is a new chemical entity licensed from NicOx for respiratory indications.
The two co-primary objectives of the study were the safety and tolerability of inhaled TPI 1020 in COPD patients and the effect of TPI 1020 on sputum neutrophil counts compared to budesonide. Neutrophils are inflammatory cells which are directly implicated in the pathology of COPD. TPI 1020 showed a numerical reduction in sputum neutrophil counts in the airways between baseline and day 42, as compared to budesonide which increased them, although the difference did not reach statistical significance (p=0.095). A similar trend for a reduction in the number of sputum neutrophils has been observed in a previous phase-2a safety study in asthmatic smokers.
The trial met its co-primary safety objective, with 33.3 per cent of patients on TPI 1020 experiencing at least one adverse event, compared to 50.0 per cent on budesonide and 12.5 per cent on placebo. Not a single serious adverse event was observed in the TPI 1020 group, in contrast to the budesonide group. In light of the efficacy results of this study, Topigen and NicOx have decided to discontinue the development of TPI 1020 in COPD and will explore potential opportunities for this compound in other indications.
Pascal Pfister chief scientific officer and head of Research & Development at NicOx, commented, "COPD is a complex disease which is very difficult to treat and proof-of-concept studies are highly challenging. Unfortunately, we did not obtain the differentiated activity in this study required to advance TPI 1020 into further development in COPD. Topigen and NicOx are currently exploring other possible therapeutic opportunities for TPI 1020 in the respiratory field."
NicOx is a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs.