On March 4, 2021 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that provides an update on its business and product pipeline (Press release, Pulmatrix, MAR 4, 2021, View Source [SID1234576078]).
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Pipeline and Business Updates:
PUR1800: 3 of 15 patients have been dosed in the Phase 1b clinical study with endpoints including safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9 month toxicology studies. Completion of these studies are important milestones under the kinase inhibitor licensing and development agreement with the Lung Cancer Initiative (LCI) at Johnson & Johnson*, which was previously on January 2, 2020.
Pulmazole: Completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole. Based on the feedback received, Pulmatrix intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) in Q1 2022. Actual study start will be determined upon Cipla and Pulmatrix joint steering committee approval of final budget and assessment of COVID-19 impact on patient safety and study operations.
PUR3100: In a dog PK study, PUR3100, a dry powder iSPERSE formulation of DHE, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE. We believe iSPERSE mitigates the manufacturing / device issues which led to MAP0004 FDA complete response letters while enabling a similar pharmacokinetic profile. As a result, PUR3100 will follow a development plan similar to the MAP0004 development program that achieved Ph3 clinical endpoints for safety and efficacy. PUR3100 plans to advance into IND enabling toxicology studies with anticipated Ph1/Ph2 clinical study start in Q1 2022.
Financing: Completed a registered direct offering with gross proceeds of $40 million extending the Company’s cash runway to fully fund data readouts across its development pipeline including PUR1800 Phase 1b, PUR3100 Phase 1 / Phase 2 and Pulmazole Phase 2b studies.
"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," said Ted Raad, Chief Executive Officer of Pulmatrix. "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."