Insmed Inc. (NASDAQ: INSM) announced that its lung disorder treatment drug was successful and met the primary goal, sending shares over 140 percent during premarket.
The clinical research of ALIS (Amikacin Liposome Inhalation Suspension) was tested on 336 patients with NTM (nontuberculous mycobacterial) lung disease. Insmed reported that the drug had eliminated the disease in 29 percent of patients by month 6, compared to the 9 percent of patients in guideline-based therapy alone.
“Our drug candidate, ALIS, delivers high levels of an aminoglycoside directly to the lung macrophages and pulmonary tissue where the infection resides, and we believe this accounts for the significant impact on conversion that the drug demonstrated in these trial results." said Paul Streck, Chief Medical 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,” said Will Lewis, President and CEO of Insmed, “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."
Currently, there is no FDA approved treatments for NTM, but Insmed says the company plans to pursue accelerated approval of ALIS based on the data from the study. The FDA has previously granted the drug breakthrough therapy designation and fast track status and allowed ALIS as a qualified product.
Shares closed on Friday at $12.29 and opened on Tuesday at $29.50, jumping over 140 percent.