Savara Ends Development of CF Therapy After Phase 3 Study Fails, Announces Reorganization

Rare Daily Staff

Orphan lung disease drug developer Savara said it would discontinue development of its inhaled antibiotic AeroVanc for people with cystic fibrosis who have drug resistant infections and take steps including layoffs to reduce expenses.

AeroVanc missed its primary endpoint in a late-stage study and failed to show that treatment with AeroVanc provided a reduction in the frequency of pulmonary exacerbations versus placebo.

Savara said it was implementing a plan to reduce overall operating expenses, including a reduction in workforce. It did not say how many employees it expects to cut. While the company is still in the process of determining final results for the fourth quarter of 2020, it expects to end the year with cash, cash equivalents, and short-term investments of approximately $82 million (unaudited) and debt of approximately $25 million.

As part of a pipeline simplification strategy that focuses resources on Molgradex for the rare lung disease autoimmune pulmonary alveolar proteinosis, the company said it has discontinued the Apulmiq clinical development program. Apulmiq is an inhaled antibiotic that was in development for the treatment of non-cystic fibrosis bronchiectasis.

Along with the changes, the company appointed Matt Pauls as chairman and CEO. Since September, Pauls has been serving as chairman and interim CEO.

“Over the last few months, we have moved decisively and with urgency on our priorities and now enter 2021 focused on our key value driver, Molgradex in aPAP and the flawless and safe execution of the IMPALA 2 trial,” he said. “I am excited to continue leading Savara and look forward to working on behalf of the aPAP community while creating shareholder value.”