Insmed Incorporated (NASDAQ: INSM) stock jumped about 113% on Tuesday, after the biopharmaceutical company announced top-line data from its Phase 3 CONVERT study.
The company announced that the global CONVERT study met its primary endpoint of culture conversion by Month 6 with statistical and clinical significance. The data shows that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum by Month 6 in 29% of patients, compared to 9% of patients on GBT alone (p <0.0001).
NTM is a rare and serious disorder associated with increased rates of morbidity and mortality. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. These patients also often require lengthy hospital stays to manage their condition.
“We consider these compelling top-line data to be a remarkable accomplishment in a rare disease state with no currently approved therapies,” said Will Lewis, President and Chief Executive Officer of Insmed. “We are particularly encouraged by the consistency of these data when compared with our Phase 2 study results, and look forward to additional data as the CONVERT study continues over the next two years. We want to thank all the patients who participated in this trial around the world as well as the physicians who supported them. Treatment of this serious and potentially debilitating disease is an unmet medical need, and we expect these important data will enable us to submit for accelerated approval.”