SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Artisan Therapeutics, Inc. (“Artisan”) and Tulex Pharmaceuticals (“Tulex”) today announced encouraging Phase 2a clinical results highlighting the potential of ART-501 for the treatment of autism spectrum disorder (“ASD”)-related conditions. In this pilot, proof-of-concept study, four out of six participants demonstrated meaningful signs of clinical benefit. ART-501 was generally well-tolerated, with adverse events reported as mostly mild and transient, and with no serious adverse events observed.

Behavioral improvements, as measured by the Aberrant Behavior Checklist – Second Edition (ABC-2), were observed in the majority of participants, with notable reductions seen in the ABC-2 subscales for irritability, lethargy/social withdrawal, stereotypic behaviors, and hyperactivity/non-compliance during low-dose ART-501 dosing compared to baseline. The ABC-2 irritability subscale is an established clinical measure that has served as a primary endpoint in FDA-approved therapies for irritability associated with ASD.

The pilot Phase 2a study was a multicenter trial conducted at two U.S. clinical sites that enrolled six adult participants with diagnostically confirmed ASD, five of whom completed treatment. The trial consisted of baseline assessments followed by an open-label period involving low-dose ART-501, then by a blinded, placebo-controlled, crossover period involving higher-dose ART-501.

Dr. Ann Childress, M.D., who was an investigator in the trial, stated, “Autism presents significant challenges for patients and their families, including repetitive behaviors, communication difficulties, and impaired social interactions.” Dr. Childress further commented, “It was very encouraging to see signals of efficacy in several of the participants in the ART-501 study, which supports continued exploration of this use of ART-501 in a larger Phase 2/3 study.”

Dr. Colleen Craig, M.D., Interim Chief Medical Officer (CMO) at Artisan Therapeutics stated, “We are deeply encouraged by the early signs of clinical benefit observed in this Phase 2a study of ART-501. These results highlight the therapeutic potential of our novel extended-release formulation in addressing core symptoms of ASD. At Artisan, our mission is to pursue science-driven innovation for underserved neurodevelopmental conditions, and this milestone represents an important step forward. We look forward to advancing ART-501 into further clinical development in collaboration with Tulex.”

About ART-501

ART-501, formerly known as ARD-501 or TLX-032 for Tulex, is a proprietary oral liquid extended-release formulation of an existing, well-tolerated opioid receptor modulating drug developed through a joint venture between Tulex and Artisan.

About Tulex Pharmaceuticals

Tulex Pharmaceuticals is a U.S. based pharmaceutical company focused on the development of NDA and ANDA products of existing molecules in new dosage forms or new routes of administration. Tulex is a wholly owned subsidiary of Easywell Biomedicals, a publicly listed company in Taiwan (TPEX: 1799.TWO).

About Artisan Therapeutics, Inc.

Artisan Therapeutics, Inc., is a wholly owned subsidiary of Aardvark Therapeutics, Inc. and is focused on the development of ART-501 through a joint venture with Tulex.

Forward-Looking Statements: Certain statements included in this press release that are not historical facts are forward-looking statements. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, Tulex’s belief that its unique expertise in developing oral liquid extended-release formulations enables the optimized delivery of an existing opioid receptor modulator offering a promising new approach for the prospective treatment of autism, the therapeutic potential of the novel extended-release formulation in addressing core symptoms of ASD and Artisan’s plans to advance ART-501 into further clinical development in collaboration with Tulex. These statements are based on current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact:

Carolyn Hawley

Carolyn.hawley@inizioevoke.com