Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced interim results from OPTIMA, a Phase 2a clinical study evaluating its lead product candidate Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of nontuberculous mycobacterial (NTM) lung infection. The ongoing study is evaluating treatment of both Mycobacterium avium complex (MAC) infection, and the more difficult-to-treat Mycobacterium abscessus (MABSC) infection. Savara believes microbiological data from this early analysis demonstrate an encouraging efficacy signal, with a favorable safety profile.
The interim analysis focused on efficacy, as assessed by microbiological results, in 14 patients who completed the 24-week treatment period and had culture results available up to at least the 16-week timepoint. Ten of the evaluable patients have MAC infection and four have MABSC infection. Of the patients with MAC infection, eight are in treatment Group 1 (on anti-mycobacterial treatment) and two are in treatment Group 2 (not on anti-mycobacterial treatment). The four evaluable MABSC patients are evenly split between both treatment groups. Safety and tolerability was assessed for all 32 patients enrolled in the study.
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