TIME is MUSCLE
OtiTopic, Inc. is in clinical stage, with a track record of success in pharmaceutical product drug delivery and drug device development. ASPRIHALE® is a proprietary aspirin formulation delivered via portable dry powder inhaler. OtiTopic is pioneering a new class of dry powder inhalation in the cardiovascular field, based on the company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables rapid inhibition of platelet aggregation, aimed at providing powerful new therapeutic capabilities. OtiTopic is dedicated to making better anti-platelet treatment, to provide high-risk MI patients with a faster-acting alternative for management of suspected acute MI. ASPRIHALE is a patient administered, portable single use device that enables oral inhalation of aspirin upon onset of MI symptoms, to reduce the risk of vascular mortality.
Phase II clinical results demonstrated complete platelet inhibition within 2 minutes. OtiTopic plans to start pivotal clinical studies for the MI indication by the end of 2020. The expected faster (2 minutes antiplatelet PD effect) complete inhibition of platelets will potentially save millions of lives after marketing approval is finalized. Regulatory filling is on track for ASPRIHALE® to file an NDA for a novel drug-device combination product in emergency management of suspected acute MI.
Inhalation via the delivery device improves the speed of aspirin bioavailability, due to bypassing first pass metabolism and the proximity of the lungs to the heart. Clinical data indicates A 1.5 fold greater maximum serum concentration (Cmax) of acetylsalicylic acid (ASA) is achieved within 2 minutes when delivered with ASPRIHALE Arachidonic acid induced platelet aggregation is completely and irreversibly inhibited with ASPRIHALE within ~2 minutes post dose, and maintained for 24 hours post treatment. Mean serum thromboxane B2 (TxB2) levels are dramatically reduced over the first ~2 minutes post dose with ASPRIHALE, and maintained for 24 hours post treatment. The immediate anti platelet and inhibitory effects of ASPRIHALE is expected to translate to meaningful clinical benefits for patients at risk for MI