Allon Provides Results For Phase-II Schizophrenia Trial

Allon has released top-line results from phase-IIa clinical trial showing that the neuroprotective drug candidate, davunetide intranasal (AL-108), has a positive impact on the ability of schizophrenia patients.

The study demonstrated davunetide to be safe and well tolerated by patients, with adverse events typical of this patient population.

The phase-IIa clinical trial was a randomized, double-blind, placebo-controlled, parallel group study. The trial was intended to assess the effect of davunetide intranasal (AL-108) in patients with schizophrenia-related cognitive impairment. Two doses of davunetide intranasal (AL-108), 5mg once daily and 15mg twice daily, were compared to placebo. Patients were treated for 12 weeks. All patients were on a stable dose of an approved anti-psychotic therapy.

Gordon McCauley, President and CEO of Allon, said: “The trial results demonstrate the potential of davunetide intranasal (AL-108) to be developed and approved as the first drug to improve the cognition of schizophrenia patients. In this small exploratory study and in a disease state where few drugs have shown positive clinical trial outcomes, we believe it is compelling to see an effect on a clinically relevant outcome measure – and one that the FDA considers a validated co-primary outcome.”

“The Phase IIa clinical trial results reconfirm the potential of davunetide intranasal (AL-108) to treat other patient groups suffering from cognitive impairment. In 2008, Allon reported Phase IIa results showing that davunetide intranasal (AL-108) had a positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease (AD),” he added.