LOS ANGELES--(BUSINESS WIRE)--OtiTopic, Inc. today announced that the U.S. Patent and Trade Office (USPTO) has granted two new patents protecting intellectual property related to its lead candidate, OTI-0726, a novel inhaled rapid-onset aspirin formulation in development for the treatment of suspected myocardial infarction (MI).
U.S. Patent No. 10,149,823, titled, “Dry powder formulations and methods of use,” and U.S. Patent No. 10,195,147 titled, “Dry powder aspirin compositions with magnesium stearate,” protect the ASPRIHALE™ formulation in the US through 2037. Technology related to ASPRIHALE™ is also protected by three previously granted utility patents, two issued by the USPTO and one issued by IP Australia and in Japan.
Approximately 735,000 Americans suffer a MI or “heart attack” every year. MIs are a result of an interruption of the blood flow to the heart caused by a blood clot. With heart muscle degradation being extremely time sensitive every second counts when it comes to a heart attack. Cardiologists have phrased "Time Is Muscle" addressing the importance of receiving treatment quickly. If blood flow is not restored to the heart muscle immediately, irreversible death of the muscle tissue will begin to occur. Most doctors recommend that anyone who thinks they are having a heart attack should take aspirin as soon as possible.
Aspirin is considered to be the standard of care for myocardial infarction risk patients in both the prophylactic and rescue setting. 90% of MI-risk patients are prescribed either daily and/or rescue aspirin, and 45% are prescribed both. Studies have shown improved mortality due to early administration of rescue aspirin upon the onset of MI.
OTITOPIC™ is the only company that has the specific patents, an opened IND and in the clinical trial stages with Dry Powder Inhalation of aspirin. OTITOPIC™ is developing ASPRIHALE™ to be administered at the time of a suspected acute myocardial infarction as a rescue option. ASPRIHALE™ is a portable Dry Powder Inhalation of aspirin that is expected to deliver a proprietary aspirin formulation deep into the lung, where it can be absorbed into the bloodstream significantly faster than an oral tablet. It will provide patients with a faster alternative for management of suspected myocardial infarction (MI). A preclinical study conducted by OTITOPIC™ has demonstrated proof of concept for rapid absorption of the formulation. They are expected to initiate a Phase 1 and Phase 2 dose range study in 2019.
Kambiz Yadidi, founder and CEO commented that, “These new patents contribute to our goal of revolutionizing the management of myocardial infarction, which is the leading cause of death in the United States. Now that we have completed our toxicology safety trial, an open IND and additional patents covering various aspects of manufacturing, particle size, formulation and method of delivery for dry powder inhalation of aspirin, we feel secure moving ahead with our clinical program. Our meetings with the FDA have given us a great deal of confidence regarding our strategy of pursuing the 505(b)(2) regulatory pathway.”
OTITOPIC™ (http://otitopic.com/) is an early stage pharmaceutical company, privately funded drug development company with a track record of success in Pharmaceutical product drug delivery and drug device development. ASPRIHALE™ is a proprietary Dry Powder Inhalation of aspirin formulation delivered via portable dry powder inhaler (DPI) that is expected to enter the bloodstream faster than oral tablets at the time of MI. OTITOPIC™ is on track with the ASPRIHALE™ to file an NDA for a novel drug-device combination product in rescue management of suspected acute myocardial infarction (MI). OTITOPIC™ is committed to provide the high-risk MI patients with a faster alternative for management of suspected myocardial infarction (MI). We have been working on developing this easy-to-use, rapid formulation since 2012 and dedicated to bringing this ASPRIHALE™ to market.