Savara has envisioned itself with a late-stage pipeline for rare, respiratory diseases. Now, in one fell swoop it has just that after acquiring the assets of Serendex Pharmaceuticals for an undisclosed amount of stock upfront—with additional cash milestone payments upon approval of the lead assets.
These include Molgradex, an inhaled form of granulocyte-macrophage colony-stimulating factor (GM-CSF) that’s in Phase II/III testing in Europe and Japan to treat autoimmune pulmonary alveolar proteinosis (PAP), and a preclinical inhaled form of Factor VIIa to treat diffuse alveolar hemorrhage (DAH).
These add to privately-held Savara’s lead product, AeroVanc, which is the first dry-powder, inhaled formulation of the antibiotic vancomycin being developed for the treatment of persistent MRSA infection in cystic fibrosis patients. It’s received fast track and orphan drug designations--and enrollment for its pivotal Phase III study is expected to start later this year.
“We had begun a process of looking for synergistic products. The company and their products were high on our list,” Savara CEO Rob Neville tells FierceBiotech. Serendex had opened up the infamous "search for strategic" options last October as it neared exhausting its funds.
“This treats a disease that’s treated with no current pharmacological therapies, the disease is well known and in academic studies it’s been shown to work. We are going into something very novel, but that’s been shown to work,” added the startup’s COO Taneli Jouhikainen on Molgradex.
Autoimmune PAP is caused by autoantibodies that disrupt the recycling of the lung surfactant function of GM-CSF. This causes excessive surfactant accumulation in the lungs, which leads to decreased gas exchange, shortness of breath and, potientially, respiratory failure. There are only about 10,000 people in the main global pharma markets with PAP.
Molgradex is also expected to also have potential in other indications--to stimulate the immune system to better kill microbes or to repair damaged lung tissue.
Up next, Savara plans to do a mezzanine funding to support it through clinical development of AeroVanc and Molgradex--and to make it through an FDA submission for them. The Austin, TX-based startup hs already raised about $53 million. Its latest financing, a $20 million Series C round backed by Carthona Capital, Haas Portman and Keiretsu Forum Northwest, came back in March.
Molgradex is already partnered with Nobel Pharma in Japan. Savara said it would be open to partnering either Molgradex or AeroVanc in Europe--but that the company aims to retain marketing rights in the U.S.
On the Serendex deal, Neville summed up: “This is transformative for us as a company. We are going from having a single asset to a pipeline of late-stage assets. This is the biggest event in our history.”
-check out the release
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