Savara Closing Trial of Molgradex in Treating NTM Lung Infections in CF Patients

Savara Pharmaceuticals is stopping its Phase 2a exploratory clinical study of Molgradex (molgramostim nebulizer solution) to treat nontuberculous mycobacterial (NTM) lung infection in people with cystic fibrosis (CF), the company announced in a press release. The decision to discontinue the open-label ENCORE trial (NCT03597347) stems from an inability to achieve the study’s primary outcome. That goal…

Phase 2a Trial Will Test Molgradex in CF Patients with NTM Infections

Savara Pharmaceuticals has launched a Phase 2a clinical study to evaluate the effectiveness of Molgradex in cystic fibrosis (CF) patients with chronic nontuberculous mycobacterial (NTM) lung infections. Molgradex is an inhaled form of artificially produced human protein granulocyte-macrophage colony-stimulating factor (GM-CSF), which normally is produced and secreted by…

2 CF Patients with Lung Infections Due to M. abscessus Show Signs of Cure Using GM-CSF, Savara Reports

Two cystic fibrosis (CF) patients being treated for lung infections related to Mycobacterium abscessus — a multidrug-resistant nontuberculous mycobacteria (NTM) — using inhaled granulocyte-macrophage colony stimulating factor (GM-CSF) now both show signs of cure, Savara Pharmaceuticals announced. M. abscessus accounts for about 35 percent of NTM infections in cystic fibrosis patients in North America, researchers…

2 CF Case Reports Show Successful Use of GM-CSF for Treating Nontuberculous Mycobacteria

Savara Pharmaceuticals announced the publication of two case reports demonstrating that inhaled granulocyte-macrophage colony stimulating factor (GM-CSF) either eradicated or dramatically reduced Mycobacterium abscessus (M. abscessus) infection, improved clinical outcomes, and was well-tolerated in patients with cystic fibrosis (CF). The results were published in the European Respiratory Journal in an…

Serendex Pharmaceuticals, Novoenzymes’ Therapy For Cystic Fibrosis, Molgradex, to Begin Clinical Trials

Denmark-based Serendex Pharmaceuticals, a company developing drugs to treat severe respiratory conditions, recently announced the initiation of a Phase I clinical trial for their drug candidate Molgradex, based on their Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). The compound uses Novozymes‘ recombinant human albumin named Recombumin as an effective, versatile stabilizer that eases…

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