AIT Therapeutics Announces Enrollment of First Patient into Its NO-NTM abscessus Phase 2 Trial in Nontuberculous Mycobacteria (NTM)
10 patients with Mycobacterium Abscessus Complex (MABSC) are expected to enroll in the trial
Data expected in the fourth quarter of 2017
AIT Therapeutics Inc. (OTC:AITB), a clinical-stage anti-microbial therapeutic company treating respiratory diseases with nitric oxide (NO), today announced the dosing of the first patient in its Phase 2 trial targeting NTM patients with MABSC.
“We are excited to advance this potentially life changing therapy for NTM patients with the dosing of the first patient in our trial. MABSC is a difficult to treat infection with a high unmet medical need. Intensive NO treatment for just 21 days may obviate the need for long term, toxic and costly antibiotic therapy, significantly benefitting patients suffering with this disease,” said Steve Lisi, Chief Executive Officer of AIT Therapeutics.
AIT has completed a Phase 1 clinical safety trial on healthy subjects, and has acquired positive human clinical data on over 50 patients with cystic fibrosis, bronchiolitis, and NTM. These data show that inhaled NO is safe with strong evidence of activity. AIT’s device is designed to safely and effectively deliver 160 ppm NO to patients for the treatment of severe lung infections.
Nitric Oxide for NTM abscessus (NO-NTM abscessus) Trial Design
The single arm, open label Phase 2 trial is expected to enroll 10 patients. Patients will be treated with inhaled NO at a concentration of 160 ppm for 30 minutes. This treatment will be administered intermittently 3 or 5 times per day over a 21-day period. The primary endpoint is safety as measured by NO-related serious adverse events (SAEs) over the 21-day treatment period. Secondary endpoints include a 6-minute walk test and Mycobacterium abscessus load in sputum. Data are expected to be announced in the fourth quarter of 2017.
NTM infection is a rare and serious condition causing debilitating pulmonary disease associated with increased morbidity and mortality. NTM is an emerging public health concern worldwide because of its multi-drug antibiotic resistance. Current treatment guidelines suggest a combination of multiple antibiotics delivered continually over one to two years. These complex, expensive and invasive regimens have a poor record for the treatment MABSC. AIT’s system is designed to effectively deliver 160 ppm NO which has been proven to eliminate bacteria, viruses, fungi and other microbes from the lungs and may work against antibiotic resistant bacteria.
“MABSC comprises a group of rapidly growing, multi-drug resistant bacteria that are responsible for a wide spectrum of pulmonary diseases predominantly in vulnerable hosts with underlying structural lung disease such as cystic fibrosis, bronchiectasis, COPD and lung cancer. The conventional anti-microbial therapies are disappointing and new treatment modalities are urgently needed. At this time, Nitric Oxide shows great promise,” said Andrew Colin, M.D., Professor of Cystic Fibrosis and Pediatric Pulmonology and Director of the pediatric CF program at the Miller School of Medicine, University of Miami.
Lea Bentur, M.D., a Principal Investigator of the NO-NTM study, and Professor of Cystic Fibrosis and Pediatric Pulmonology and Director of the Pediatric Pulmonary unit at the Rambam Medical Center in Israel commented, “Currently available antibiotics for NTM have a very low success rate against MABSC. Nitric Oxide has the potential to not only save lives, but also improve the quality of life for MABSC patients.”
“Current treatment for NTM lung disease requires one to two years of treatment with multiple antibiotics that have very limited efficacy, especially in MABSC, and carry the risk of adverse events that can impact quality of life well beyond the end of treatment. The NO-NTM trial offers patients a 21-day treatment that may significantly shorten the duration of toxic antibiotic therapy,” added Ori Efrati, M.D., a Principal Investigator of the NO-NTM study and Professor of Cystic Fibrosis and Pediatric Pulmonology and the Head of the Pediatric Pulmonology Unit at the Safra Children’s Hospital in Tel Hashomer, Israel.
In addition to the trial in NTM patients, AIT is also conducting a Phase 3 trial in infants hospitalized due to bronchiolitis. The majority of admissions with bronchiolitis are caused by respiratory syncytial virus (RSV). RSV is a common and highly transmissible virus that infects the respiratory tract of most children before their second birthday. While in most infants RSV presents with minor respiratory symptoms, a small percentage develop serious lower airway infections, termed bronchiolitis, which can become life-threatening. The absence of treatment options for bronchiolitis limits the care of these extremely sick infants to largely supportive measures. Data from this trial are expected in the first half of 2018. Regulatory filings for both bronchiolitis and NTM are anticipated prior to the end of 2019.
Nitric oxide (NO) is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, NO is believed to play a key role in the innate immune system at concentrations of approximately 200 ppm. In vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, both gram positive and gram negative, but also against other diverse organisms including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate their multi-drug resistant strains.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage anti-microbial therapeutic company using nitric oxide (NO) to treat respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections which are not effectively addressed with current standards of care. AIT Therapeutics is advancing its revolutionary respiratory targeted system in clinical trials for the treatment of bronchiolitis (RSV) and nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.