According to the company, TPI 1020 showed 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 chronic obstructive pulmonary disease (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. 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% of patients on TPI 1020 experiencing at least one adverse event, compared to 50% on budesonide and 12.5% on placebo, the company said.
In light of the efficacy results of this study, Topigen and NicOx have decided to discontinue the development of TPI 1020 in COPD and are expected to explore potential opportunities for this compound in other indications.
Pascal Pfister, chief scientific officer and head of R&D at NicOx, said: 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.