Benzinga | Sep 22, 2020 08:36AM EDT

Pulmatrix Reports Progress On Product Pipeline

LEXINGTON, Mass., Sept. 22, 2020 /PRNewswire/ --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(tm) technology, provides an update on product pipeline.

"COVID-19 has presented us with some challenges, but we are positioned to make progress across our product pipeline," said Ted Raad, Chief Executive Officer of Pulmatrix. "During 2020, Pulmatrix has raised over $30M through partnerships and public financing, allowing us to advance three programs towards potential proof of concept data."

Pipeline Update:

* PUR1800: Patient dosing for the PUR1800 Ph1b is planned to start in Q1 2021 and we expect both the Ph1b and 6-month toxicology data in Q3 2021. Delivery of the Ph1b study clinical study report will trigger a $2M milestone payment from Johnson & Johnson under the option to license agreement with Johnson & Johnson. Delivery of the Ph1b and 6-month toxicology data are the triggers for the three-month Johnson & Johnson option period. Should Johnson & Johnson exercise its option to license PUR1800, Pulmatrix will receive a $14M option exercise payment.

* PUR3100: We are advancing a program in migraine, a disorder with over 30M patients and significant unmet need. We anticipate having a lead formulation for a non-clinical PK study in Q4 2020. Based on clinical and regulatory precedents, after completing a 14-day GLP toxicology study in 2021, we believe a Ph1/1b study can be initiated in Q1 2022 and that should enable a Ph3 study in mid-2023.

* Pulmazole: Together with our partner Cipla Technologies LLC, we decided to end our Phase 2 clinical study of Pulmazole for the treatment of asthma patients with ABPA. COVID-19 had a significant impact on enrollment in the first half of this year and the study was initially put on hold as the pandemic spread in 2Q 2020. After significant discussions with the investigators, we decided to stop the study and intend to start a new larger Phase 2b study designed with a longer treatment duration and key phase 3 enabling efficacy endpoints. Also being considered are clinical studies in India, South Africa and other regional markets where Cipla has strong clinical development and business capabilities and the potential assignment to Cipla of exclusive rights to develop and commercialize Pulmazole in these territories is currently under consideration. We plan to have a Type-C meeting with the FDA in Q1 2021 to inform our final clinical design and timelines. We plan to commence the new Phase 2b study when the risk of insufficient patient enrollment presented by the ongoing COVID-19 pandemic is reduced to an acceptable level.