Johnson & Johnson has decided not to exercise an option acquired in a 2020 agreement with Pulmatrix for development and commercialization of Pulmatrix’s portfolio of inhaled narrow spectrum kinase inhibitors (NSKIs), including PUR1800. J&J’s Lung Cancer Initiative had been interested in developing the dry powder formulation for lung cancer interception. Pulmatrix licensed the NSKI portfolio from J&J subsidiary RespiVert in June 2017.
According to Pulmatrix, data from a Phase 1b study of PUR1800 for acute exacerbations in COPD (AECOPD) is expected by the end of 2021, and the company intends to initiate a Phase 2b study of the DPI for the treatment of AECOPD sometime this year [Pulmatrix has since corrected its statement to say that the Phase 2 study is expected to take place in 2022]. In addition, the company said that it expects to have data from 6- and 9-month toxicology studies in the third quarter of 2021 and noted that it could potentially expand development of PUR1800 to other chronic respiratory diseases based on those data
Pulmatrix CEO Ted Raad said, “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. 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 2b study in AECOPD treatment, which has the potential for approximately $2.5 billion in US 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.”
Read the Pulmatrix press release.