Pieris Pharmaceuticals said that part 1a of a clinical trial of PRS-060/AZD1402, a dry powder IL-4 receptor alpha inhibitor which the company is developing with AstraZeneca for the treatment of moderate-to-severe asthma, has been completed. Pieris said that it now expects AstraZeneca to start enrolling patients with asthma that is insufficiently controlled by medium doses of ICS-LABA in part 2a of the study, which will evaluate two doses of twice daily PRS-060/AZD1402 versus placebo over 4 weeks following a 4-week run-in period.
Enrollment is also expected to begin in part 1b of the trial, which will evaluate the safety of a higher dose of PRS-060/AZD1402 in patients with controlled asthma. If the outcome of the 1b study is positive, the third dose level will be evaluated alongside the two lower doses in part 2b of the study.
Pieris announced in 2017 that AstraZeneca had acquired development rights to Pieris’s PRS-060 and other inhaled anticalin therapies. The company says that it will have 30 days following the availability of topline data from the Phase 2a study to decide to continue co-development of the DPI with AstraZeneca.
Pieris President and CEO Stephen S. Yoder said, “We are excited about the progression into the efficacy portion of the study of PRS-060/AZD1402. We believe this drug candidate has the potential to expand the access of asthmatics worldwide to highly effective therapies. The successful completion of the phase 2a study would serve as a key value inflection point in the development of this large market opportunity program and inform our decision to co-develop PRS-060/AZD1402 alongside AstraZeneca.”
Read the Pieris Pharmaceuticals press release.
