橫幅
18
2025.11
Tulex Pharmaceuticals and Artisan Therapeutics Announce Positive Phase 2a Results for ARD-501, a Novel Oral Liquid Extended-Release Formulation for Autism Spectrum Disorder
Tulex and Artisan Report Positive Phase 2a Results for Autism Drug ARD-501
Tulex Pharmaceuticals (“Tulex”), and Artisan Therapeutics Inc. (“Artisan”) today announced encouraging Phase 2a clinical results highlighting the potential of ARD-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. ARD-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 ARD-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. “Autism presents significant challenges for patients and their families, including repetitive behaviors, communication difficulties, and impaired social interactions,” said James Lee, Ph.D., CEO at Tulex. “We believe Tulex’s 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 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 ARD-501, then by a blinded, placebo-controlled, crossover period involving higher-dose ARD-501.
Dr. Ann Childress, M.D., who was an investigator in the trial, commented, “it was very encouraging to see signals of efficacy in several of the participants in the ARD-501 study, which supports continued exploration of this use of ARD-501 in a larger Phase 2/3 study.”
Dr. Lee also stated “We are deeply encouraged by the early signs of clinical benefit observed in this Phase 2a study of ARD-501. These results underscore 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 ARD-501 into further clinical development in collaboration with Tulex.”
About ARD-501
ARD-501 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. (Nasdaq: AARD) and is focused on the development of ARD-501 through a joint venture with Tulex.
Tulex Pharmaceuticals (“Tulex”), and Artisan Therapeutics Inc. (“Artisan”) today announced encouraging Phase 2a clinical results highlighting the potential of ARD-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. ARD-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 ARD-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. “Autism presents significant challenges for patients and their families, including repetitive behaviors, communication difficulties, and impaired social interactions,” said James Lee, Ph.D., CEO at Tulex. “We believe Tulex’s 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 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 ARD-501, then by a blinded, placebo-controlled, crossover period involving higher-dose ARD-501.
Dr. Ann Childress, M.D., who was an investigator in the trial, commented, “it was very encouraging to see signals of efficacy in several of the participants in the ARD-501 study, which supports continued exploration of this use of ARD-501 in a larger Phase 2/3 study.”
Dr. Lee also stated “We are deeply encouraged by the early signs of clinical benefit observed in this Phase 2a study of ARD-501. These results underscore 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 ARD-501 into further clinical development in collaboration with Tulex.”
About ARD-501
ARD-501 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. (Nasdaq: AARD) and is focused on the development of ARD-501 through a joint venture with Tulex.