September 5, 2017
By Alex Keown, BioSpace.com Breaking News Staff
BRIDGEWATER, N.J. – Shares of Insmed Incorporated are up more than 111 percent this morning after the company announced its Phase III lung cancer drug Alis achieved its primary endpoints.
Company leadership is hoping the positive results will lead the U.S. Food and Drug Administration to grant accelerated approval of Alis based on data from the late stage trial. This morning the company said Alis, an inhaled once daily formulation of amikacin, eliminated evidence of Nontuberculous Mycobacterial (NTM), a lung disease caused by Mycobacterium avium complex (MAC) in sputum at the six month mark in 29 percent of patients. That was compared to the 9 percent of patients who benefitted from standard of care, the company said. Those results announced today were certainly pleasing to investors. Shares of Insmed closed on Friday at $12.29. This morning shares hit a high of $29.52 as of 9:30 a.m. Prices have slid back a little to $26.23 per share as of 11:18 a.m.
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. They often require long hospital stays.
Will Lewis, president and chief executive officer of Insmed, hailed the top-line data as a “remarkable accomplishment” for a rare disease that has no current approved therapies. He said treatment of the debilitating disease is an unmet medical need and the company hopes the data will convince the FDA to quickly approve the drug.
Insmed Chief Medical Officer Paul Streck said the trial is an important milestone in the company’s quest to develop a treatment for NTM patients caused by MAC. The current guideline-based therapy which the company used to compare Alis is not approved for the treatment of this disease, but is generally regarded as the best available option for these patients, he said.
“We are particularly encouraged by the consistency of these data when compared with our Phase II study results, and look forward to additional data as the CONVERT study continues over the next two years,” Lewis said in a statement.
Not only did Alis hit its primary endpoints, the drug also hit multiple secondary endpoints. Insmed said Alis was able to help patients who achieved culture conversion were able to improve their six-minute walking distance in comparison to patients who did not culture convert. Top-line data for the secondary endpoint of time to conversion demonstrated that patients on guideline-based therapy (GBT) took approximately 30 percent longer to convert when compared to patients on ALIS plus GBT, the company said this morning.
Dr. David Griffith of the University of Texas Health Sciences Center and principal investigator of the Alis trial said he was encouraged by the six-minute walking test results as it demonstrated an improvement in the quality of life for patients with NTM.
“I am extremely pleased with and impressed by the culture conversion results that ALIS demonstrated in treatment-refractory patients with NTM lung disease caused by MAC. The eradication of MAC is the first and most important goal for treatment of patients with MAC lung disease,” Griffith said in a statement.
