Nov 27 17
AIT Therapeutics, Inc. announced that preliminary results from its NO-NTM Phase 2 study in Nontuberculous Mycobacteria (NTM) targeting patients suffering from Mycobacterium Abscessus Complex (MABSC) indicate that the primary endpoint of safety was met, with no NO-related serious adverse events (SAEs) observed. The safety data, along with positive results in other key parameters, drive AIT’s decision to move the program forward and plan for a potential pivotal trial to begin in the United States in the second half of 2018. All patients in the trial were refractory to the standard-of-care for MABSC and had underlying cystic fibrosis. Patients were treated with inhaled NO in addition to background antibiotic therapy at the physicians’ discretion. NO was delivered at a concentration of 160ppm for 30 minutes intermittently for 21 days (5 times per day for 14 days and then 3 times per day for a subsequent 7 days), after which no further NO treatments were provided. As per the protocol, all patients will be followed for 81 days. Nine patients were enrolled in the study and all have completed the 21-day dosing schedule. Data presented below are through Day 51 (30 days post completion of treatment) for the endpoints of 6-minute walk (6MW) and forced expiratory volume (FEV1). The primary endpoint of safety, as well as the endpoints of mycobacterium abscessus (M. abscessus) load in sputum and quality-of-life (QoL), assessed at Day 21. The Company anticipates having all data collected by the end of the first quarter of 2018. The Company plans to continue developing its inhaled NO therapy for this indication and expects to begin enrollment in a potential pivotal study in the U.S. in the second half of 2018. With the proprietary NO generator technology, the Company believes it has the ability to deliver inhaled NO to the patient at home, beyond the 21-day treatment period used in the current trial. https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=266763185