As Savaras cystic fibrosis development program comes to an end, so will the CEO Rob Nevilles 12-year reign at the company.
Following him out the door is his co-founder Taneli Jouhikainen, Savaras president and chief business officer, whos resigning to pursue other opportunities. Matthew Pauls, the former chief of Strongbridge and a member of the board, is stepping in as chairman and interim CEO.
The Austin-based biotech $SVRA still has high faith in molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), and its potential to treat a rare autoimmune lung disorder. A pivotal Phase III trial is planned for the first quarter of 2021.
Last week the company officially shut down an exploratory Phase II trial in CF. After two years of investigating whether the drug can reduce lung infection in adult patients, execs said Vertexs new triple-combination drug plus disruptions due to the Covid-19 pandemic essentially rendered a conclusion impossible.
With Molgradex we have the potential opportunity to bring the first approved therapy for autoimmune pulmonary alveolar proteinosis to market, Pauls said in a statement. We also look forward to disclosing top line results from the Phase 3 AeroVanc AVAIL study early next year and getting regulatory feedback on the Apulmiq clinical development program.
Despite landing breakthrough therapy designation from the FDA, though, molgradex has its share of controversy after missing the primary endpoint and multiple secondary endpoints in an earlier Phase III.
Badrul Chowdhury, a seasoned FDA staffer who moved from AstraZeneca to Savara last November, is staying to steer the drive to market as chief medical officer.
Original post:
Savara's long-reigning duo both resign in the wake of CF bust - Endpoints News
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