Savara has acquired rights to an amikacin/fosfomycin inhalation solution that was being developed by Cardeas Pharma for the treatment of ventilator associated pneumonia and has appointed former Cardeas Pharma CEO A. Bruce Montgomery as a strategic advisor, the company said.
The company also announced a public offering of common stock, with shares priced at $11.50 per share, that is expected to raise almost $50 million. According to Savara, the company expects to invest $5-10 million per year in a new exploratory pipeline with the inhaled amikacin/fosfomycin as the first new candidate.
Montgomery is currently CEO of Avalyn Pharma (formerly Genoa Pharmaceuticals), which is developing inhaled pirfenidone for the treatment of idiopathic pulmonary fibrosis.
He commented, “I am excited to become an advisor to Savara at such an important time in the company’s development. I believe the results of the planned and underway clinical trials in multiple rare lung diseases will go far to meet Savara’s vision of becoming ‘The Orphan Lung Disease Company.’ I have provided input on the development of Molgradex and AeroVanc for many years and look forward to assisting Savara’s team with these programs that address unmet medical needs. In addition, I look forward to assisting the company in identifying and evaluating new impactful products to help fuel the company’s growth.”
The company also said that it is gearing up for a potential commercial launch of Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), saying that it hopes for breakthrough therapy designation that would allow for submission of a biologic license application for Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) in early 2020, followed by commercial launch in late 2020 or early 2021.
Savara said that its confidence in that schedule is supported by positive feedback from investigators and enthusiasm from patients regarding the ongoing Phase 3 IMPALA and IMPALA-X studies of Molgradex for the treatment of aPAP. According to the company, of 14 patients eligible for enrollment in IMPALA-X, 10 have already enrolled, and the remaining 4 are expected to enroll once their clinical sites receive the drug.
Molgradex is also in Phase 2 development for the treatment of nontuberculous mycobacterial (NTM) lung infection and recently announced good results in 2 cystic fibrosis patients. Now the company says that it plans to initiate a new study of Molgradex in CF patients with chronic NTM infection in early 2019.
Savara CEO Rob Neville said, “This business update on Molgradex emphasizes the gradual inclusion of a strong commercial focus within Savara in addition to our activities in product development, and it represents an important step in our evolution towards a fully integrated pharmaceutical company with our own product revenues.”
President and COO Taneli Jouhikainen commented, “The expansion of our NTM program, and the launch of our exploratory pipeline underline our commitment to growth through innovation and acquisition. We are delighted to have Dr. Montgomery – one of the most accomplished entrepreneurs in our field – join us on this exciting journey. Dr. Montgomery is a leading innovator in inhaled antibiotics and orphan lung diseases in general, and we are proud to welcome him to assist our team.”
Read the Savara press release on the pipeline update.
Read the Savara press release on the public offering of common stock.
