AB-2004 / Vertero Therapeutics - LARVOL DELTA

AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=156 | Completed | Sponsor: Vertero Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Autism Spectrum Disorder • Genetic Disorders

AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=156 | Active, not recruiting | Sponsor: Axial Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2023 ➔ Dec 2023

Enrollment closed • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Axial Therapeutics Announces Age Expansion in Global Phase 2b Clinical Trial for Irritability Associated with Autism Spectrum Disorder (ASD) (GlobeNewswire) - "Axial Therapeutics...today announced it is expanding the age eligibility criterion to include children ages 5 to 17 years, previously restricted to ages 13 to 17 years. The age expansion is part of a protocol amendment in the company’s global Phase 2b clinical trial for lead candidate, AB-2004, a gut-targeted, molecular therapeutic that is being studied for alleviating the irritability associated with Autism Spectrum Disorder (ASD). 'We are pleased to announce that children ages 5 to 17 are now eligible to participate in our ongoing Phase 2b clinical trial of AB-2004 for the treatment of irritability associated with ASD, and we look forward to finalizing enrollment later this year.'"

Enrollment status • Trial status • Autism Spectrum Disorder • Developmental Disorders

AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Axial Therapeutics, Inc. | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Axial Therapeutics Expands Clinical Development Capabilities with Key Appointments (GlobeNewswire) - “Clinical development operations focused on ongoing Phase 2b clinical trial of AB-2004 in autism; data anticipated in 2023…Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to the development of gut-targeted, small molecule therapeutics for neurological conditions and oncology, today announced that it is building on its clinical development science and operations capabilities through recent key appointments….‘We are excited to be moving to this next stage of the company’s growth with the addition of these key clinical development team members as we advance our Phase 2b clinical trial for AB-2004 to treat irritability associated with autism…’”

P2b data • Autism Spectrum Disorder • Developmental Disorders

Safety and target engagement of an oral small-molecule sequestrant in adolescents with autism spectrum disorder: an open-label phase 1b/2a trial. (PubMed, Nat Med) - "Here we report that an oral GI-restricted adsorbent (AB-2004) that has affinity for small aromatic or phenolic molecules relieves anxiety-like behaviors that are driven by a gut microbial metabolite in mice...These results from an open-label study (trial registration no. ACTRN12618001956291) suggest that targeting gut-derived metabolites with an oral adsorbent is a safe and well-tolerated approach to improving symptoms associated with ASD, thereby emboldening larger placebo-controlled trials."

Journal • P1/2 data • Autism Spectrum Disorder • Gastrointestinal Disorder • Genetic Disorders • Mood Disorders • Psychiatry

AB-2004 in Treatment of Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=195; Recruiting; Sponsor: Axial Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Autism Spectrum Disorder • Genetic Disorders

AB-2004 in Treatment of Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=195; Not yet recruiting; Sponsor: Axial Therapeutics, Inc.

Clinical • New P2 trial • Autism Spectrum Disorder • Genetic Disorders