Acasti Renamed Grace Therapeutics, Inc.

Acasti Pharma Inc., a later-stage biopharmaceutical company, has announced its intention to adopt the name Grace Therapeutics, Inc. from October 28, 2024. This change reflects the company’s extensive scientific heritage and established corporate brand equity. Grace Therapeutics will trade on Nasdaq under the symbol "GRCE." The company is known for advancing GTx-104, an innovative injectable formulation of nimodipine designed to meet significant unmet medical needs for patients suffering from aneurysmal subarachnoid hemorrhage (aSAH).

According to Prashant Kohli, CEO of Acasti, the rebranding to Grace Therapeutics serves to reconnect the company with its foundational roots in scientific innovation. The journey of developing GTx-104 has spanned over a decade of rigorous research performed by a dedicated scientific team. This work initially began when Grace Therapeutics was located in New Jersey, a renowned pharma industry corridor. GTx-104 is currently in the late stages of clinical development, with complete enrollment in the STRIVE-ON trial. The company anticipates data from this trial to be available early in 2025, followed by an expected submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2025.

In the past 18 months, Acasti has undergone significant transformation. The company has restructured itself into a more agile biopharma model, revamped its management team, streamlined its pipeline, divested from legacy assets, and strengthened its financial standing. Furthermore, Acasti has transitioned to being a Delaware corporation, which is expected to enhance its appeal to potential strategic partners and global institutional investors. Kohli expressed pride in the rapid progress made and emphasized that the rebranding to Grace Therapeutics would help fully realize the company's value.

Grace Therapeutics is scheduled to host a Key Opinion Leader (KOL) event on November 20, 2024, entitled "Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage," to discuss the implications and progress of GTx-104. This event will be available for replay for at least 180 days after the webcast.

Acasti's asset portfolio includes GTx-104, a novel, injectable formulation of nimodipine aimed at treating aSAH patients through intravenous infusion. This formulation uses unique nanoparticle technology to allow for a standard peripheral IV infusion, potentially eliminating the need for nasogastric tube administration for unconscious or dysphagic patients. GTx-104 has shown promise in reducing food effects, drug-to-drug interactions, and the risk of dosing errors, while also managing hypotension in aSAH patients. The drug has been administered to over 150 healthy volunteers and demonstrated lower pharmacokinetic variability compared to oral nimodipine. The estimated market for GTx-104 in the U.S. is around $300 million.

Other assets in the company's portfolio include GTx-102 and GTx-101, although their development has been deprioritized to focus resources on GTx-104. GTx-102 is an oral-mucosal spray of betamethasone intended for improving neurological symptoms of Ataxia-Telangiectasia (A-T), while GTx-101 is a topical bio-adhesive film-forming bupivacaine spray for managing postherpetic neuralgia (PHN). Both GTx-102 and GTx-101 might be licensed or sold in the future.

Acasti, now Grace Therapeutics, continues to leverage its innovative drug delivery technologies to improve the performance of existing drugs, aiming for faster onset of action, enhanced efficacy, reduced side effects, and more convenient delivery methods. The company’s lead assets have been granted Orphan Drug Designation by the FDA, providing seven years of market exclusivity post-launch in the U.S. and additional intellectual property protections with over 40 granted and pending patents.