Savara Pharmaceuticals, an emerging specialty pharmaceutical company, has acquired the assets of Serendex Pharmaceuticals adding two new programs to its pipeline. The lead product of Serendex, Molgradex, is an inhaled form of granulocyte-macrophage colony-stimulating factor (GM-CSF), currently in a phase II/III clinical study in Europe and Japan to treat autoimmune pulmonary alveolar proteinosis (PAP). The acquisition is subject to customary closing conditions, including approval by Savara’s shareholders.
“The acquisition is a transformational milestone for Savara, expanding our pipeline of orphan respiratory drugs with an exciting product for a highly debilitating disease with no approved medicinal treatments,” said Rob Neville, chief executive officer of Savara Pharmaceuticals. “Molgradex is a beautiful fit with our lead product, AeroVanc, and has the potential to be a truly disease-modifying treatment for PAP based on clinical evidence from academically sponsored pilot studies and case reports on inhaled GM-CSF.”
Molgradex is a nebulized form of recombinant human GM-CSF, delivered using the PARI eFlow high-efficiency rapid nebulizer system. The lead indication of Molgradex, autoimmune PAP, is caused by autoantibodies that disrupt a key function of GM-CSF in the lungs, recycling of the lung surfactant. The functional GM-CSF deficiency causes excessive surfactant accumulation in the lungs, leading to decreased gas exchange, shortness of breath and even respiratory failure. PAP affects approximately 10,000 people in the main global pharmaceutical markets. Serendex has recently begun enrollment in a phase II/III trial of Molgradex, which will allow submission of a marketing authorization application in Europe and Japan.
In addition to PAP, Molgradex has potential in other indications by stimulating the innate immune system to enhance microbial killing or repair of impaired lung tissue. The second product acquired in the deal is an inhaled form of Factor VIIa, a promising preclinicalstage product for a rare lung disease called diffuse alveolar hemorrhage (DAH). DAH is a potentially life threatening form of bleeding into the alveoli of the lungs where oxygen exchange takes place.
Savara Pharmaceuticals is a specialty pharmaceutical company focusing on innovative drugs for the treatment of serious and life-threatening rare respiratory diseases.
Established in 2008 in Copenhagen, Denmark, Serendex Pharmaceuticals has focused on developing novel inhalation therapies for the treatment of patients with rare respiratory conditions.