Post by icemandios on Apr 14, 2021 3:12:38 GMT
Corrected: Pulmatrix to Regain Full Rights to PUR1800 and Narrow Spectrum Kinase Inhibitor Portfolio
Termination of License, Development and Commercialization Agreement with the Lung Cancer Initiative at Johnson & Johnson will Return Portfolio to Pulmatrix
Pulmatrix to continue development of PUR1800 for treatment of Acute Exacerbations in Chronic Obstructive Pulmonary Disease (AECOPD) with Phase 1b Study Ongoing with Data Expected Q4 2021
Long-term Toxicology Data in Q3 2021 has Potential to Broaden Development to Additional Indications Requiring Chronic Dosing
PR Newswire
LEXINGTON, Mass. , April 12, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), is re-issuing this press release solely to correct inadvertent typographical errors under the heading "Updated PUR1800 Program Guidance" which incorrectly noted that Pulmatrix plans to initiate a PUR1800 Phase 2 proof-of-concept efficacy study for the treatment of AECOPD in 2021. This study is not expected to commence until 2022 All other data and disclosure remain unchanged.
The corrected press release reads in its entirety as follows:
LEXINGTON , Mass., April 12, 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, today announced it will regain full rights to its narrow spectrum kinase inhibitor (NSKI) portfolio, including PUR1800, following Johnsons & Johnson's Enterprise Innovation's decision to terminate the Company's license, development and commercialization agreement. Pulmatrix intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in COPD (AECOPD) and other chronic airway diseases.
Updated PUR1800 Program Guidance:
28-day toxicology studies are complete, demonstrating dose proportional systemic exposure, reduced potential for lung drug accumulation, improved physical and chemical stability, and potential for long-term dosing as compared to non-iSPERSE formulation drug predecessor (RV1162).
Dosing in the ongoing Phase 1b clinical study of PUR1800 in AECOPD is ongoing. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect, with topline data expected in Q4 2021.
Pulmatrix plans to initiate a PUR1800 Phase 2 proof-of-concept efficacy study for the treatment of AECOPD in 2022.
Data from 6 and 9-month long-term toxicology studies are expected in Q3 2021. These long-term data have the potential to broaden the development of PUR1800 for chronic dosing paradigms where non-steroidal inti-inflammatory treatment may be of benefit, such as asthma, COPD and other chronic airway diseases.
"Regaining full rights to PUR1800, and the broader portfolio of NSKIs, positions Pulmatrix to independently advance assets that have the potential to address multiple blockbuster markets," said Ted Raad , Chief Executive Officer of Pulmatrix. "Our prior agreement with Johnson & Johnson greatly advanced our PUR1800 program, fully funding both our ongoing Phase 1b study and ongoing long-term toxicology studies. With data from these studies expected before year end, we expect to be positioned to advance our planned Phase 2 study in AECOPD treatment, which has the potential for approximately $2.5 billion in U.S. peak net revenue potential. Importantly, our long-term toxicology studies also have the potential to broaden the reach of PUR1800 to indications beyond AECOPD that require long-term dosing. We look forward to continued progress with PUR1800 and believe our superior iSPERSE formulation has the opportunity to address steroid resistant and infection driven inflammation across a diverse range of lung conditions."
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA") and lung cancer, as well as neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
Termination of License, Development and Commercialization Agreement with the Lung Cancer Initiative at Johnson & Johnson will Return Portfolio to Pulmatrix
Pulmatrix to continue development of PUR1800 for treatment of Acute Exacerbations in Chronic Obstructive Pulmonary Disease (AECOPD) with Phase 1b Study Ongoing with Data Expected Q4 2021
Long-term Toxicology Data in Q3 2021 has Potential to Broaden Development to Additional Indications Requiring Chronic Dosing
PR Newswire
LEXINGTON, Mass. , April 12, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), is re-issuing this press release solely to correct inadvertent typographical errors under the heading "Updated PUR1800 Program Guidance" which incorrectly noted that Pulmatrix plans to initiate a PUR1800 Phase 2 proof-of-concept efficacy study for the treatment of AECOPD in 2021. This study is not expected to commence until 2022 All other data and disclosure remain unchanged.
The corrected press release reads in its entirety as follows:
LEXINGTON , Mass., April 12, 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, today announced it will regain full rights to its narrow spectrum kinase inhibitor (NSKI) portfolio, including PUR1800, following Johnsons & Johnson's Enterprise Innovation's decision to terminate the Company's license, development and commercialization agreement. Pulmatrix intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in COPD (AECOPD) and other chronic airway diseases.
Updated PUR1800 Program Guidance:
28-day toxicology studies are complete, demonstrating dose proportional systemic exposure, reduced potential for lung drug accumulation, improved physical and chemical stability, and potential for long-term dosing as compared to non-iSPERSE formulation drug predecessor (RV1162).
Dosing in the ongoing Phase 1b clinical study of PUR1800 in AECOPD is ongoing. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect, with topline data expected in Q4 2021.
Pulmatrix plans to initiate a PUR1800 Phase 2 proof-of-concept efficacy study for the treatment of AECOPD in 2022.
Data from 6 and 9-month long-term toxicology studies are expected in Q3 2021. These long-term data have the potential to broaden the development of PUR1800 for chronic dosing paradigms where non-steroidal inti-inflammatory treatment may be of benefit, such as asthma, COPD and other chronic airway diseases.
"Regaining full rights to PUR1800, and the broader portfolio of NSKIs, positions Pulmatrix to independently advance assets that have the potential to address multiple blockbuster markets," said Ted Raad , Chief Executive Officer of Pulmatrix. "Our prior agreement with Johnson & Johnson greatly advanced our PUR1800 program, fully funding both our ongoing Phase 1b study and ongoing long-term toxicology studies. With data from these studies expected before year end, we expect to be positioned to advance our planned Phase 2 study in AECOPD treatment, which has the potential for approximately $2.5 billion in U.S. peak net revenue potential. Importantly, our long-term toxicology studies also have the potential to broaden the reach of PUR1800 to indications beyond AECOPD that require long-term dosing. We look forward to continued progress with PUR1800 and believe our superior iSPERSE formulation has the opportunity to address steroid resistant and infection driven inflammation across a diverse range of lung conditions."
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA") and lung cancer, as well as neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.