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Find Clinical Drug Pipeline Developments & Deals by Gossamer Bio
Gossamer intends to use the net proceeds to fund the ongoing development and commercialization of GB002 (seralutinib), a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and c-KIT, for the treatment of pulmonary arterial hypertension (PAH).
The FDA has now placed a clinical hold on all trials of GB5121, which was being tested for primary central nervous system lymphoma. Now, all work related to GB5121 has been discontinued and the ongoing studies shelved.
The efficacy results generated with GB002 (seralutinib) in the context of a favorable safety and tolerability profile highlight compelling potential differentiation for seralutinib as an anti-proliferative, anti-inflammatory, and anti-fibrotic therapeutic candidate.
Gossamer intends to use the net proceeds from the proposed financing to fund research and development of its other product candidates and development programs and for working capital and general corporate purposes.
Seralutinib (GB002) is an inhaled PDGFRα and PDGFRβ inhibitor. The primary objective for this trial is to determine the effect of GB002 on improving pulmonary hemodynamics in subjects with WHO Group 1 PAH who are Functional Class II and III.
Neither statistically significant nor clinically meaningful differences were observed for primary endpoint and secondary endpoints, including histologic and mucosal healing endpoints, for either GB004 treatment group relative to placebo at week 12.
Presentation includes clinical and biomarker data from the ongoing GB1275 Phase 1/2 clinical trial, KEYNOTE-A36, in advanced solid tumors and corresponding presentations from Johanna Bendell, M.D. and Wells Messersmith, M.D.
The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups.
Gossamer Bio will present data relevant to GB004 at United European Gastroenterology Virtual Week 2020, which takes place from October 11th through 13th.
Gossamer Bio will present four posters with data relevant to its GB001 and GB002 programs at the Virtual European Respiratory Society International Congress 2020.