Kamada has announced that preliminary results from its Phase 2/3 pivotal trial of its inhaled Alpha-1 Antitrypsin (AAT) therapy showed no difference between inhaled AAT and placebo in “time to first moderate or severe exacerbation,” the primary endpoint. The 50-week study involved 168 patients.
The company said that the frequency of severe exacerbations in patients treated with inhaled AAT, however, was approximately half that of patients in the placebo group, and “the data showed efficacy in certain subsets of patient populations.” Additionally, FEV1 “indicated positive trends in improvement.”
Kamada VP of Clinical Development and Intellectual Property Pnina Strauss said, “We received preliminary trial results, and today are reporting partial and early stage data regarding the primary endpoint and certain key secondary endpoints. We have detected clinically meaningful signs for inhaled AAT efficacy as well as additional positive signs in specific study populations, and are examining these data further to better understand the results and to assure the information is valid and correlates with additional clinical parameters . . . . We believe the existing data support a regulatory filing in Europe, and will continue as planned to meet with the EMA according to the centralized procedure for licensure during the fourth quarter of this year.”
Read the Kamada press release.
