Ladenburg starts AIT Therapeutics at buy

Ladenburg Thalmann launched coverage of AIT Therapeutics (NASDAQ:AITB) with a “buy” rating and $17 price target. The stock closed at $5.50 on Aug. 4.

AIT is currently developing its proprietary nitric oxide (NOx) to treat lower respiratory tract infections, such as bronchiolitis exacerbations and nontuberculous mycobacteria (NTM).

AIT’s NOx is currently in Phase 2 development for the treatment of NTM and in Phase 3 development for the treatment of bronchiolitis. The company’s lead program, NOx for the treatment of bronchiolitis exacerbations, which require hospitalization, is in Phase 3 development.

Analyst Matthew Kaplan writes that the company has already reported impressive Phase 2 data, showing NOx treatment resulted in a significant reduction in hospitalization time and a significant improvement in time to normalization of oxygen saturation levels.

“We are encouraged by the Phase 2 results and believe there is strong likelihood for a positive readout for the study based on the strength of the Phase 2 data in this patient population,” he added.

Mr. Kaplan said Phase 3 bronchiolitis data is expected in the first quarter of 2018 and the program is on track for an NDA filing in the U.S. and EU by early 2019, with approval expected by the first half of 2020.

NOx also is in Phase 2 development for the treatment of NTM. AIT has already reported initial clinical data in two patients with NTM in the compassionate use setting.

Mr. Kaplan said the data from the two NTM patients showed a marked reduction or eradication of NTM colony forming units and an improvement in symptoms and well being of the two patients. Although limited to two subjects, “we view these data as very encouraging,” with top-line data from the Phase 2 NTM study expected in the fourth quarter of 2017.

“We believe the program is on track to enter Phase 3 development in 2018 with Phase 3 data expected in mid-2019,” he added.