Texas-based biotech Savara is killing off much of its pipeline work amid a staffing cull as it sets its focus on troubled lung disease therapy Molgradex.
First up, its pipeline. The biotech said the phase 3 trial of AeroVanc (vancomycin hydrochloride inhalation powder) in cystic fibrosis patients who have methicillin-resistant Staphylococcus aureus lung infection missed its primary endpoint and will now be culled.
Its main goal had been mean absolute change from baseline in FEV1: The data were miserable and showed a mean change from baseline in FEV1 percent predicted compared to placebo of 1.4 at week 4 (p=0.33), 1.3 at week 12 (p=0.33), and 3.0 at week 20 (p=0.07) in young patients.
AeroVanc also failed to lower frequency of pulmonary exacerbations versus placebo.
The biotech has also been working on Apulmiq (an inhaled form of ciprofloxacin) in non-cystic fibrosis bronchiectasis, but this too has been canned.
The R&D focus now lays on Molgradex in its phase 3 treating lung disease autoimmune pulmonary alveolar proteinosis (aPAP). This experimental med has, however, also been beset by woe over the years, including failing a primary endpoint in this setting last year.
It had also been tested in cystic fibrosis, but Savara culled all work for Molgradex in that indication after a new winner-takes-all competitor from Vertex.
The company is working on a follow-up phase 3 for Molgradex in aPAP, known as IMPALA 2, though this is not going smoothly. “While the company is working to initiate the phase 3 IMPALA 2 trial in North America, Europe, and Asia as quickly and as safely as possible, the impact of the COVID-19 pandemic on the trial continues to evolve,” it said.
“To ensure COVID-19 mitigation strategies are in place, the company today revised guidance on the initiation of IMPALA 2 and now expects the trial to start in Q2 2021, versus the end of Q1 2021.”
The biotech is also cutting costs, mainly by cutting staffers, although we don’t know how many yet. “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,” it said in a statement.
Shares in the company fell 13.8% on the news Thursday but ticked up by nearly 3% after-hours.
“I am grateful for the opportunity to be a part of the Savara team,” said Matt Pauls, who has also become the permanent chairman and CEO of the company after serving on an interim basis.
“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. Finally, I am excited to continue leading Savara and look forward to working on behalf of the aPAP community while creating shareholder value.”