Savara has updated two case reports published in the European Respiratory Journal in April 2018 that describe the treatment of nontuberculous mycobacterial (NTM) lung infection Mycobacterium abscessus using Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with cystic fibrosis. M. abscessus is a multidrug resistant NTM.
The article reported that the M. abscessus infection was eradicated by the inhaled GM-CSF in the first patient and that the second patient had a strong response to the treatment. According to Savara, both patients have now experienced meaningful clinical improvement and culture conversion.
Savara announced the initiation of the Phase 2a OPTIMA study of Molgradex for the treatment of chronic NTM lung infections in March 2018. The company expects completion of the study in the third quarter of 2018, with topline results available in the first half of 2019.
Mark E. Wylam of the Mayo Clinic, the senior author of the article, commented, “This is a remarkable result given that this second subject, unlike the first one, was not treated with NTM antibiotics. Both subjects remain on aerosolized GM-CSF and have experienced clinically meaningful improvements in weight gain and lung function. I believe these case studies strongly reinforce the scientific rationale for the treatment of NTM lung infection using inhaled GM-CSF, and I look forward to the results of Savara’s ongoing OPTIMA study.”
Read the Savara press release.
