AMO Pharma has reported updated positive results from its Phase II TIDE trial evaluating the safety and efficacy of AMO-02 (tideglusib) for the treatment of patients with autism spectrum disorder (ASD).
ASD is a condition that affects an individual's communication and behaviour.
Results showed that the once-daily treatment for the core symptoms of ASD was found to be generally safe and well-tolerated among patients.
Patients receiving AMO-02 recorded improvements over placebo in measures of social withdrawal (ABC-Social) and repetitive behaviours (RBS-R), as well as daily living skills (Vineland), memory (NEPSY) and sleep quality (CSHQ).
No treatment-related serious adverse events were reported in the trial and adverse event rates were generally found to be similar between tideglusib and placebo.
AMO Pharma chief medical officer Dr Joseph Horrigan said: “There has been very little progress in research related to treatment of ASD over the past decade, while the incidence of ASD seemingly continues to rise.
“These results provide a new level of hope that treatment with AMO-02 has the potential to offer meaningful, multi-symptom benefit in ASD and merits further study as a potential treatment for ASD.”
TIDE was a randomised, 1:1 double-blinded study that enrolled 83 adolescents with ASD.
Patients received AMO-02 or placebo over a 12-week treatment period, with follow-up at four weeks.
The trial saw the start of daily dosing at 400mg, which was increased incrementally up to 1,000mg based on the patient’s weight.
Outcome measures of the trial were based on several parameters, including rating scales completed by caregivers and clinicians.
The trial was conducted at three clinical facilities in Canada and was funded by Ontario Brain Institute, Brain Canada and Azrieli Foundation.