Savara Pharmaceuticals has announced that it is halting development of its AeroVanc vancomycin DPI after the Phase 3 AVAIL trial of AeroVanc for the treatment of MRSA lung infections in cystic fibrosis patients failed to meet its primary endpoint. The AVAIL trial, which was initiated in 2017, failed to show statistically significant improvement in lung function or a reduction in exacerbations. The company also recently discontinued development of Molgradex inhaled human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection.
Savara said that it will now focus its efforts the Phase 3 IMPALA 2 trial of Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP). The first Phase 3 IMPALA study failed to meet its primary endpoint; however, a patient advocacy organization is encouraging the FDA to approve Molgradex for aPAP. According to the company, initiation of the IMPALA 2 study is facing delays due to the COVID-19 pandemic, and the trial is now expected to begin in the second quarter of 2021.
In addition to halting development of AeroVanc, the company is also halting development of Apulmiq (Linhaliq) inhaled liposomal ciprofloxacin, which was originally developed by Aradigm. Grifols acquired the Aradigm portfolio of inhaled ciprofloxacin products after Aradigm’s bankruptcy, and Savara acquired the rights to Apulmiq from Grifols earlier this year. The company also said that it is laying off some employees to reduce expenses.
Savara Chief Medical Officer Badrul Chowdhury said, “We extend our gratitude to the patients and clinical trial staff who participated in AVAIL. On behalf of people living with CF, we hope data from the trial will benefit future research of inhaled antibiotics in MRSA lung infections. Unfortunately, based on the AVAIL results, we are discontinuing further development of AeroVanc.”
The company’s co-founders, who had served as CEO and President, left Savara in September 2020. Current Chairman and CEO Matt Pauls commented, “I am grateful for the opportunity to be a part of the Savara team. 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.”
Read the Savara Pharmaceuticals press release.
