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Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned

Gossamer Bio and Chiesi Farmaceutici have partnered to develop and commercialize Gossamer’s seralutinib inhalation powder for the treatment of pulmonary hypertension, the companies announced. Chiesi, which will get 50% of US commercial profit and ex-US rights to seralutinib, will pay Gossamer $160 million for development reimbursement; up to $146 million in regulatory milestones; and up to $180 million in sales milestones.

The companies said that a Phase 3 trial of seralutinib in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) is expected to begin in mid-2025. Gossamer announced positive results from a Phase 2 trial of the DPI in pulmonary arterial hypertension (PAH) in December 2022. The ongoing Phase 3 PROSERA Study of seralutinib in PAH was initiated in December 2023.

Gossamer Chairman and CEO Faheem Hasnain commented, “This partnership with Chiesi allows us to meaningfully deepen and rapidly accelerate our investment in seralutinib as a potential treatment for PAH, PH-ILD, and other indications of high unmet medical need. We are particularly thrilled that this collaboration enables seralutinib to move directly into a Phase 3 trial in PH-ILD, an indication with a paucity of available treatments, and a disease which we believe seralutinib is specifically designed to address.”

Chiesi Group CEO Giuseppe Accogli said, “Seralutinib is a potential paradigm shifting therapy in PAH and PH-ILD, and we could not be more excited to partner with Gossamer to develop and bring this therapy to patients world-wide. Gossamer shares Chiesi’s commitment to using innovation to promote the health and well-being of people around the world and we are proud to add this collaboration as a key pillar to our next phase of growth.”

Read the Gossamer Bio and Chiesi press release.

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published on May 7, 2024

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