The US Patent and Trademark Office (USPTO) has granted OtiTopic, Inc. two patents covering its Asprihale (OTI-0726) inhaled aspirin formulation, which OtiTopic is developing as a rescue treatment for suspected myocardial infarction (MI), the company announced. According to OtiTopic, the Asprihale DPI is also covered by utility patents from the US, Japan, and Australia.
OtiTopic also said that it has completed a preclinical trial demonstrating that the formulation is rapidly absorbed and that the company expects to begin dose ranging studies in 2019.
The new patents — No. 10,149,823 (“Dry powder formulations and methods of use”) and No. 10,195,147 (“Dry powder aspirin compositions with magnesium stearate”) — provide protection through 2037. According to the company, the USPTO has previously granted two utility patents related to Asprihale, and the company has also been granted patents in Australia and Japan.
OtiTopic Founder and CEO Kambiz Yadidi said, “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.”
Read the OtiTopic press release.
