Two weeks after dropping chronic obstructive pulmonary disease (COPD) candidate TPI 1020 after disappointing Phase II data, Topigen Pharmaceuticals Inc. reported another Phase II miss, this time with its asthma drug TPI ASM8.
Results of the 14-day, 18-patient study showed that the inhalable product failed to demonstrate statistical significance in the primary efficacy endpoint, defined as late asthmatic response following a controlled allergen challenge in patients with mild asthma. While the drug was able to attenuate a rise in sputum eosinophils post-allergen challenge by 50 percent, that difference was not statistically significantly greater compared to placebo.
But the Montreal-based firm said trends were observed on other endpoints consistent with promising results from earlier studies, and added that a "blunted and variable response" to the allergen challenge might have impaired the ability to determine a clear treatment effect. Given those reasons, Topigen said further studies of TPI ASM8 are warranted.
Citing the drug's "compelling clinical profile," Topigen CEO Mark Parry-Billings said in a press release that the firm plans to expand the TPI AMS8 development program by initiating additional dose-finding studies in the first half of this year.
TPI ASM8 stems from Topigen's oligonucleotide technology and is designed to significantly reduce the recruitment and persistence of chronic inflammatory cells and their release of cytokines. The drug aims to inhibit the recruitment of allergic inflammatory cells by targeting the CCR3 receptor and to reduce the persistence of allergic inflammatory cells by targeting the beta subunit for the receptors of interleukin-3, IL-5 and GMS-CSF.
The company also is continuing to advance programs in COPD. Although it halted development late last month of TPI 1020, a candidate licensed from NicOx SA, of Sophia Antipolis, France, Topigen reprioritized its pipeline and will move forward with TPI 1100, an inhaled phosphodiesterase 4 and PDE7 inhibitor, which is expected to start clinical testing this year.