Insmed Inc. shares skyrocketed 130% in extremely heavy Tuesday morning trade after the company announced that a phase 3 trial for its rare lung disease therapy met its primary endpoint. The company said it plans to pursue accelerated approval for the therapy, ALIS, which was previously granted breakthrough therapy designation and fast track status by the Food and Drug Administration. ALIS is intended for treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex, a rare and serious disease that has such symptoms as fever, weight loss, cough, blood in mucus and night sweats. NTM lung disease has become more prevalent in the U.S. in recent years, and treatments fail relatively frequently. ALIS is a formulation of the antibiotic amikacin that can be taken once a day. Amikacin’s use is “limited by the need to administer it intravenously and by toxicity to hearing, balance and kidney function,” Insmed said. By contrast the technology used in ALIS brings the antibiotic directly to the lung, which “prolongs the release of amikacin in the lungs while minimizing systemic exposure thereby offering the potential for decreased systemic toxicities,” the company said. Relative to guideline-based therapy (GBT), rates of safety issues in patients treated with ALIS and GBT was higher, though safety issues “were predominately mild or moderate in nature and generally declined after the second month of treatment,” the company said. The dropout rate for patients on GBT was about 9%, while the dropout rate for patients on ALIS and GBT was 19.6%. Insmed shares have surged 84.5% over the last three months to $28, compared with a 1.2% rise in the S&P 500 .
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