Danish inhaled drug developer Serendex has announced that it has met a number of milestones this year in preparation for clinical development of its portfolio. According to Serendex, in the first quarter of 2015, the company obtained a GMP certificate to allow it to manufacture its own clinical trial supplies and has initiated a Phase 1 clinical trial of its Molgradex inhaled recombinant granulocyte macrophage colony stimulating factor (GM-CSF), which it is developing for the treatment of pulmonary alveolar proteinosis (PAP), acute respiratory distress syndrome (ARDS), cystic fibrosis, and bronchiectasis.
The company said that it obtained DKK 30 million in the form of an undrawn committed credit facility from Sorana A/S, a major shareholder. It also also announced that it had signed a development and commercialization agreement with CMC Biologics for an inhaled factor VIIa as well as a partnership with the Universities of Giessen and Marburg Lung Center for a Phase 2 study of inhaled GM-CSF for the treatment of ARDS.
Serendex CEO Kim Arvid Nielsen said, “Although this transition of becoming a clinical company is a major milestone for Serendex, it is merely an element of the long term development strategy that was laid out in the beginning of 2014. The positive scientific advice from EMA in January 2015 fully supports this strategy containing one pivotal Phase 2/3 trial for GM-CSF for the treatment of PAP with an estimated start in 2H 2015 and an estimated marketing authorization in 2018.”
In addition to GM-CSF and factor VIIa, Serendex is developing inhaled formulations of fosfomycin and activated protein C.
Read the Serendex press release.
