Acasti Pharma to Attend BIO 2024

PRINCETON, N.J., May 28, 2024 - Acasti Pharma (Nasdaq: ACST), a biopharma firm focused on late-stage development, has announced its participation in the upcoming BIO International Convention scheduled at the San Diego Convention Center from June 3-6, 2024. The company is putting forth its innovative injectable nimodipine formulation, GTX-104, aimed at addressing critical needs for patients suffering from aneurysmal subarachnoid hemorrhage (aSAH). Chief Executive Officer Prashant Kohli is slated to meet with pharmaceutical executives to discuss potential partnerships and strategic opportunities for the company’s asset portfolio during the conference. Interested parties can request a meeting through the BIO International meeting portal.

Understanding aSAH

Aneurysmal Subarachnoid Hemorrhage (aSAH) is characterized by bleeding over the brain's surface in the subarachnoid space, which houses blood vessels supplying the brain. This condition is often triggered by an aneurysm rupture. Statistically, around 70% of aSAH patients either die or become dependent, with over 30% succumbing within a month post-hemorrhage. Annually, around 50,000 individuals in the United States are diagnosed with aSAH.

Acasti’s GTX-104: A Potential Game-Changer

GTX-104 is designed as an advanced, injectable nimodipine formulation for intravenous infusion, targeting aSAH patients. Utilizing unique nanoparticle technology, GTX-104 allows for an aqueous formulation of nimodipine suitable for standard IV infusion. This innovation aims to simplify nimodipine delivery in Intensive Care Units (ICUs), potentially eliminating the need for nasogastric tube use in unconscious or dysphagic patients. Furthermore, IV delivery of GTX-104 may reduce food effects, drug interactions, and dosing errors, while potentially improving hypotension management.

Clinical trials have shown that GTX-104, administered to over 150 healthy volunteers, is well-tolerated with significantly lower pharmacokinetic variability compared to oral nimodipine. Market research estimates the US market opportunity for GTX-104 at around $300 million, with approximately 60,000 annual cases in the European Union and about 150,000 in China.

Other Promising Assets: GTX-102 and GTX-101

Acasti is also developing GTX-102, a concentrated oral-mucosal spray of betamethasone aimed at ameliorating neurological symptoms of Ataxia-Telangiectasia (A-T), a rare condition without existing FDA-approved therapies. This stable oral spray can be conveniently administered over the tongue, ensuring rapid absorption.

Additionally, GTX-101 is a unique, non-narcotic, topical bupivacaine spray designed to alleviate symptoms of postherpetic neuralgia (PHN). This metered-dose spray forms a bio-adhesive film on the skin, providing a touch-free, non-greasy application. It offers the potential for rapid pain relief onset and sustained pain control for up to eight hours, without causing skin sensitivity, as indicated in Phase 1 trials.

About Acasti Pharma

Acasti Pharma is dedicated to developing novel drug delivery technologies aimed at improving the performance of existing drugs by enhancing efficacy, reducing side effects, and ensuring faster onset of action. The company’s lead assets, including GTX-104, have been granted Orphan Drug Designation by the FDA, offering seven years of market exclusivity in the U.S. post-launch and additional intellectual property protection through more than 40 patents.

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