Pulmatrix has announced plans for clinical development of PUR3100, an iSPERSE dry powder formulation of dihydroergotamine (DHE) for the treatment of migraine, after a PK study in dogs showed exposure kinetics similar to those of the Levadex (MAP0004, Semprana) DHE MDI. The company also provided updates on its development programs for Pulmazole and PUR1800 and said that it has raised $40 million for the three programs through a registered direct offering.
MAP Pharmaceuticals, and later Allergan, never succeeded in getting Levadex approved, Pulmatrix notes; however, the company says, “We believe iSPERSE mitigates the manufacturing / device issues which led to MAP0004 FDA complete response letters while enabling a similar pharmacokinetic profile.” The company added that its development plan for PUR3100 will be similar to that of MAP0004 and that it expects to initiate a Phase 1/2 clinical trial in the first quarter of 2022.
Pulmatrix also said that it has held a Type C meeting with the FDA regarding Pulmazole (PUR1900) dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) and expects to begin a Phase 2b trial in the first quarter of 2022, with the actual timing dependent on budget and COVID-19 considerations. Pulmatrix is partnered with Cipla on development of Pulmazole. In July 2019, the company announced the initiation of a Phase 2 trial of Pulmazole in asthma patients with ABPA.
In addition, the company reports that a Phase 1b study of PUR1800, a kinase inhibitor licensed from the Lung Cancer Initiative (LCI) at Johnson & Johnson, has dosed 3 patients out of an expected 15, and topline data are expected in the fourth quarter of 2021.
Pulmatrix CEO Ted Raad commented, “We are very excited to have three iSPERSE enabled programs with potential to address significant unmet need in lung cancer, allergic bronchopulmonary aspergillosis, and acute migraine. We have made significant advancements across every program and our now strengthened balance sheet leaves us well positioned to execute across our diversified pipeline to key data readouts and get one step closer to bringing these important therapies to patients.”
Read the Pulmatrix press release.
