Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

AIT Therapeutics Announces Further Data From Its NO-NTM Abscessus Phase 2 Clinical Trial in Nontuberculous Mycobacteria (NTM) Patients


Posted on: 22 Jan 18

Mycobacterium Abscessus Load Reduced by 65%

6-Minute Walk Improvement Maintained at Day 81

NEW YORK, Jan. 22, 2018 (GLOBE NEWSWIRE) -- AIT Therapeutics Inc. (OTC:AITB), a clinical-stage biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with serious lung infections and pulmonary hypertension, today announced positive data at Day 81, the end of its NO-NTM Abscessus clinical trial.  The Company previously announced positive preliminary data through Day 51.

“We continue to be delighted with the data from this trial.  With just 21 days of treatment patients are still benefitting at Day 81 as shown by 6-minute walk data.  Additionally, the anti-microbial effect of NO is apparent with qPCR showing a 65% reduction in bacterial load,” said Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics.  “Our proprietary system with our NO generator may allow AIT to treat patients at home for an extended period of time, possibly at a higher NO concentration, potentially improving on the strong results shown in our completed study.”

All patients in the trial were refractory to the standard-of-care for NTM abscessus (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 a 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 were followed for 81 days.

Mycobacterium abscessus load, as measured by quantitative PCR (qPCR), showed a mean reduction of 65% at Day 81 versus baseline.  Data for 6-minute walk and FEV1% are shown in Figures 1 and 2, respectively. 

Andrew Colin, M.D., Director, Division of Pediatric Pulmonology at the University of Miami, and the Principal Clinical Consultant of the NO-NTM study opined, “The benefits of nitric oxide are clearly demonstrated in this trial.”  Dr. Colin further added, “MABSC patients at this level of severity, mostly have a downhill trajectory and very limited therapeutic options.  The possibility of using AIT’s system to treat patients chronically, at home, is a very promising development.  I am looking forward to assisting AIT in getting their system approved, and use it to study a broader array of patients with cystic fibrosis and other chronic lung diseases.”

AIT plans to meet with the United States Food and Drug Administration (FDA) in the second quarter of 2018 to discuss the plans for a pivotal trial that will allow AIT to gain regulatory approval to help combat the effects of NTM infections.  Based on feedback from this upcoming meeting, AIT will provide more specific timing for the commencement of a pivotal trial.  AIT is enthusiastically committed to developing NO therapy to help patients suffering from NTM. 

About Mycobacterium abscessus complex (MABSC) of the Lungs
MABSC is the most aggressive and difficult to treat form of non-tuberculous mycobacteria (NTM). There are currently no approved treatments for MABSC. Current standard-of-care is a cocktail of antibiotics that often proves to be ineffective with severe adverse effects.  Most patients suffering from MABSC have an underlying disease, such as cystic fibrosis or chronic obstructive pulmonary disease (COPD). The median survival of those suffering from MABSC is less than 5 years.

About NO
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.  At concentrations below 80 ppm, NO has proven to be an effective vasodilator in the pulmonary vasculature.

About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat serious lung infections and pulmonary hypertension.  The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care.  AIT Therapeutics is advancing its revolutionary NO respiratory targeted system in clinical trials for the treatment of bronchiolitis and for nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.

Forward-Looking Statement
This press release contains “forward-looking statements.”  Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects.  You can identify such forward-looking statements by the words “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets,” “potential,” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters.  Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made.  Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements.  These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance.  Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history.  We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACT
Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
Steve@AIT-Pharm.com

Bob Yedid
LifeSci Advisors, LLC
Bob@LifeSciAdvisors.com
(646) 597 6989

Photos accompanying this announcement are available at 

http://www.globenewswire.com/NewsRoom/AttachmentNg/3a5e6a9a-0457-4085-b46a-4773199c8a9c

http://www.globenewswire.com/NewsRoom/AttachmentNg/bc57f6d5-e3a4-45c3-b51f-ab3d598fb53f

GlobeNewswire
globenewswire.com

Last updated on: 23/01/2018

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.