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TIME is MUSCLE


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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

Regulatory Pathway Timeline

  • 2017

    Non Clinical Studies Completed 2017

  • 2018

    IND Filed

  • 2019

    Phase 1 Dose Range PK / PD Clinical Study Completed

  • 2020 Q1

    FDA Type C Meeting

  • 2020 Q1

    Scale Up of Manufacturing

  • 2020 Q4

    Pivotal PK/PD Clinical Studies

  • 2021

    Filing of NDA

Our Mission

Revolutionizing Myocardial Infarction Management


Our mission is to provide patients with a faster alternative for management of suspected acute MI. The estimated annual incidence of MI in the US is 805,000. An estimated 79 million people in the US with cardiovascular risk factors are at high or intermediate risk for MI. Recent American College of Cardiology and American Heart Association guidelines indicate that chewing aspirin at the onset of MI symptoms is preferable to taking daily

We have developed a proprietary formulation delivered via dry-powder inhaler (DPI) for treatment of MI that enters the bloodstream in less than two minutes. We have been working on developing an easy-to- use, rapid formulation since 2012 and are dedicated to bringing this medication to market.

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