Investors, if you have not yet met AIT Therapeutics Inc (OTC:AITB), consider yourself privileged to be provided an introduction. Now, although that prior statement may read as presumptuous, once investors get initiated to the premise that AITB sits ideally positioned to alter the therapeutic landscape for treating respiratory infection and pulmonary hypertension, the favorable opinion is undoubtedly substantiated.
In fact, not only is AITB on its way to becoming a potential market disruptor, undertaking aggressive steps to bring to market a revolutionary platform of Nitric Oxide treatment, but they are also doing it in a manner that may ultimately secure a dominant and leading position in how, and in what amounts, Nitric Oxide may be used to treat several debilitating infections and disease indications.
Nitric Oxide May Be A Seriously Valuable Compound
Before jumping into the absolute specifics of AITB, it's important first to highlight the significance of utilizing Nitric Oxide (NO) to treat a specific disease and bacterial infections. Nitric Oxide is a chemical compound produced naturally by cells within the body which work to help relax vascular smooth muscles, which when functioning correctly promotes vasodilation, or the widening of blood vessels. Today, Nitric Oxide is commonly used medicinally in newborn babies who have trouble breathing, working by reducing pulmonary vascular pressure and improving the baby's ability to breathe efficiently. Nitric Oxide is also notable for its potent antibacterial properties and high cell penetrability, which has made the compound the subject of numerous studies to prove its value for treating acute and chronic lung infections. NO inhalation therapy, itself, has earned significant interest within the last decade as a non-antibiotic method of treating lower respiratory tract infections, specifically nontuberculous mycobacteria (NTM) and Bronchiolitis. Although inhalation therapy is still undergoing collective research, published clinical results indicate that the benefits from a proven and effective NO regimen could be revolutionary in how many disease and infection-based illnesses get treated. While it is widely acknowledged that inhalation of Nitric Oxide can be harmful outside of a medical setting, the FDA is looking beyond intentional abuse and recognizes the compounds value, supported by a favorable safety profile shown to have little to no side effects when used under the proper precautions and medical supervision. This positive view by the regulatory agencies may ultimately allow AITB to circumvent extensive and financially burdensome studies on long-term safety potentially.
That's all good for AIT Therapeutics. In 2011, AITB proved successful in developing a novel and proprietary technology that could safely deliver NO gas to patients via inhalation. The technique is a considerable achievement, and the efficacy of NO therapy has already demonstrated the potential to provide superior therapeutic results compared to traditional standard of care treatments. Currently, the AIT device is uniquely designed to safely deliver NO to the patient at a concentration of 160 ppm (parts per million). This ratio is a notable improvement over similar therapeutic options on the market, such as Ikaria's Nitric Oxide device, which is limited to a maximum of 80 ppm in intubated patients. AITB's contribution, on the other hand, allows for not only a safe treatment, but also provides a substantially higher level of delivery intensity from its patent-pending three gas combination that does not need patient intubation. With this clinically proven technology strengthening the cause for further research, AITB is continuing their progress through validating clinical studies to determine the optimal rate and method of NO transmission to the patient. As of 2016, the company has completed four trials to analyze both the safety and efficacy of their inhaled NO therapy in patients with Bronchiolitis, cystic fibrosis, or NTM. In all four studies, no serious adverse events (SAE) were observed in any of the patients treated, and as of the latest 2016 trial, a clinically significant reduction in bacterial load was observed in NTM patients, suggesting a strong likelihood that future results may continue to show clinical promise. And, if those results prove to be statistically significant, AITB may be set on an expedited path for FDA and EMEA approval and will be apt to become one of the primary breakthrough leaders in this revolutionary field of treatment.
AITB Puts Nitric Oxide to Work
AITB has dedicated the majority of their research toward the use of inhaled NO therapy as a safer and more beneficial alternative to traditional treatments for patients with certain types of lung infections and pulmonary hypertension. The company is now targeting mycobacterium abscessus complex, or MABSC, which is recognized as one of the most aggressive and difficult to treat conditions caused by NTM, and is only one of over 150 identified species of NTM that most often infects subjects through inhalation from the environment. Patients with underlying lung disease, such as cystic fibrosis or COPD, or a weakened immune system are at higher risk of acquiring the condition. In 2014, there were an estimated 180,000 new cases of NTM in the United States, with over 20% of these cases being MABSC. Another manifestation of the disease, NTM mycobacterium avium complex (NTM MAC), is also being targeted by AITB. Patients with MAC have a median survival rate of 13 years, and this number gets reduced to only 4.6 years in patients with non-MAC NTM (essentially MABSC), so it is crucial that a safe and effective treatment be developed and implemented to prevent or stifle this fatal disease. Despite the relative surge in the development interest of inhaled NO therapy, there exist only a few companies working in the NTM space, and competitively favorable to AITB, there is currently little to no competition in the MABSC space, creating a generous opportunity for AITB to capitalize on that lucrative market.
AITB is now progressing through clinical studies of their proprietary NO inhalation therapy in cystic fibrosis patients with MABSC, and is reporting promising interim results. In one study, two patients were treated with a regimen designed to fit the specifics of their disease indication, and in both patients, MABSC values notably decreased during and after AITB's inhalation-delivered NO treatment. Before the AITB treatment, both patients received prior care with current standard of care drugs, which is a cocktail of antibiotics known to cause undesirable side effects including blindness, deafness, liver damage, gastrointestinal disturbance, hypersensitivity, and more. Complimenting AITB's Nitric Oxide treatment, however, the study patients experienced no adverse events and were benefited from a significantly reduced load of mycobacterium abscessus. In fact, Patient 2 was determined to be mycobacterium abscessus negative by culture 20 months after the initial eradication with Nitric Oxide treatment. Encouraged by these favorable results, AITB has completed dosing of nine more patients infected with MABSC and is waiting for the data to mature before informing investors prior to the end of this year. The study points for the trial will continue to observe the safety profile and efficacy data from the NO treatment and will scrutinize data to pinpoint the optimal concentration of NO inhalation levels. Again, it is important to note that no other company currently has the technology to replicate the method and delivery properties utilized by AITB, and with interim results demonstrating promising value, AITB is in an enviable position to advance its platform to become a leading provider for treating most all NTM related diseases.
Another Focus Is On Bronchiolitis
Not only has AITB produced promising results in NTM, but they have also reported encouraging results from their Phase 2 trial in treating Bronchiolitis with Nitric Oxide therapy. Bronchiolitis is a lower respiratory tract infection that occurs commonly in infants or the elderly, with over 400,000 hospitalizations per year in the United States alone. Important to note, there are currently no drugs approved to treat Bronchiolitis, limiting hospitals and treatment centers in their ability to assist patients by providing only a steady supply of oxygen and hydration. Sadly, while the total United States market size for a Bronchiolitis treatment is estimated to eclipse $2 billion, there existed no meaningful options available to patients that offered a new and effective treatment - that is, until AITB stepped in.
Understanding that their inhaled NO technology could be a perfect candidate to meet both patient and market needs, the company designed and recently completed their Phase 2 clinical trial in treating Bronchiolitis. And, like their studies with NTM, the early results have proved promising. In a double-blind study, 21 Bronchiolitis patients were placed on a regimen of NO therapy for five days, while another 22 Bronchiolitis patients were treated with only the current standard of care of oxygen and hydration. At the end of the study, the amount of time necessary to reach acceptable oxygen levels was found to be 80% faster with inhaled NO therapy relative to the standard treatment. Additionally, the mean time to oxygenation was only 35 hours in the NO group, while the standard control cohort averaged 63 hours. What's more, is that this expedited rate of recovery shortened the hospital stay of the NO-treated patients by one day – a 34% decrease in hospitalization time compared to the patients treated with standardized care. Also, similar to the results from the NTM testing, patients experienced no significant adverse effects when treated with NO. Translating those findings, they may indicate that AITB's NO therapy has considerable advantages over the current standard of care in treating Bronchiolitis. And, with no other company aggressively exploring or competing in the full Bronchiolitis space, AITB is positioned ideally to capitalize on the recognition, market need, and associated revenue of bringing a viable and valuable treatment to Bronchiolitis patients worldwide.
AITB Is A Forward Thinking, Market Disruptor
Here's where it gets interesting for investors. Not only is AITB perpetuating its potentially revolutionary technology, but the company remains active toward expanding upon their proprietary foundation through accretive acquisitions to further improve and broaden their existing technology and market reach. On November 1, AITB announced it would be acquiring an exclusive license to the eNOGenerator and certain assets from NitricGen, Inc. The acquisition is a potentially massive deal for AITB on several levels, because, with the eNOGenerator incorporated into the AIT NO delivery system, the company is now able to provide the same therapy at an even more efficient, customizable, and cost-effective rate than before. The eNOGenerator ensures the ability to generate NO on demand and deliver it to the lungs at a precise and desired concentration, with a range of 1 ppm to 400 ppm. AITB has previously focused on providing NO at 160 ppm, and adding this innovative technology will allow them to quickly adjust their treatment for indications that may require a different concentration of NO. Next, the acquired device's ability to generate NO on demand eliminates the need for the sizable and high-pressure NO cylinders used in the hospital setting, replacing cumbersome systems with the new AITB generator weighing only 7 pounds. Not only does the reduced scale remove the need for hospitals to acquire additional supporting resources, but it also allows users to receive active treatment within a household setting. Finally, along with the eNOGenerator and the included assets, the agreement also brings two experienced executives to the AITB team, Fred Montgomery and Duncan Bathe. Montgomery and Bathe combine for well over 24 years of experience in researching and developing NO delivery technology, and respectively hold over 30 patents in the NO delivery system space, including the eNOGenerator purchased by AITB. Now able to reap the advantages from this added expertise and industry experience, AITB's mission of improving and replacing the many outdated and inefficient standards of care with their novel method of inhaled NO therapy gets strengthened significantly.
In addition to their acquisition of the eNOGenerator, AITB also has secured many patents of their own, with 19 currently issued patents and over 20 patent applications in process. The company has been awarded patents for both their method and delivery processes of inhaled NO to treat various illnesses, and combined with their recent acquisition, AITB aims to expand upon these current patents to Bronchiolitis and their technological scope and improve upon their already successful treatments. In addition to ongoing studies, AITB is increasing focus to include the use of NO to treat inflammatory airway disease and to potentiate antibiotic therapies. AITB plans to advance through Phase 2/3 clinical trials to target and treat Bronchiolitis and NTM throughout the next few years and is planning to begin studies targeting the NO treatment of Chronic Obstructive Pulmonary Disease, wound healing, and pulmonary hypertension within the next two years. As of November 2, AITB is sitting at $4.96 per share, with 6.04 million shares outstanding and a market cap of $30.22 million. The company has no debt and is likely to secure additional funding for their pivotal U.S. clinical trials in 2018.
Disruption Is Good, And So Is AITB
Overall, investors would be smart to consider a serious look into the potential offered by AITB. Clinical trials have shown the company's technology to substantially improve upon the current standards of care in virtually every respect, and without the adverse side effects brought on by more traditional treatments. There is little to no competition in the markets targeted by AITB, and if their platform proves to be the breakthrough technology it is shaping up to be, the company would undoubtedly have a probable chance at becoming the clear service provider in the industry. Led by a team of experienced professionals with a vision of improving care for those who need it most, AITB deserves the consideration of any investor looking for an emerging company with a strong clinical foundation and market disruptive technology.
This article was originally featured on CNA Finance.
The author has no shares in any stock mentioned herein.