Pulmatrix said that it has received a Study May Proceed letter from the FDA for a Phase 2 study of its PUR3100 dihydroergotamine mesylate inhalation powder for the treatment of migraine. Pulmatrix announced results from a Phase 1 PK study of PUR3100 in January 2023.
The company’s pipeline already includes one inhalation powder in Phase 2 development, with a Phase 2b trial of PUR1900 dry powder itraconazole in patients with allergic bronchopulmonary aspergillosis (ABPA) and asthma initiated earlier this year. PUR1800, an inhaled kinase inhibitor, is listed on the company’s web site as “Ph 2 ready.”
Pulmatrix Chief Medical Officer Margaret Wasilewski said, “We are pleased with the PUR3100 IND acceptance and receipt of the study may proceed letter for the Phase 2, proof of concept study. We are looking forward to building on the positive safety and pharmacokinetic data established in our Phase 1 study.”
CEO Ted Raad commented, “We believe that PUR3100 has the potential to be differentiated from other approved acute migraine therapies currently available on the market, given the convenience of self-administration and the potential for rapid pain relief and improved DHE tolerability. The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE. We are currently pursuing options to advance PUR3100 into a Phase 2 clinical trial to investigate PUR3100 efficacy, safety, tolerability in treating acute migraine subjects.”
Read the Pulmatrix press release.
