January 06, 2006

Saegis completes Phase IIa study

Saegis Pharmaceuticals announced this week that they have successfully completed a Phase IIa study of the new drug candidate identified as "SGS518" , a selective antagonist for the 5-HT 6 subtype of the serotonin receptor that is being developed as a treatment for cognitive impairment associated with schizophrenia (CIAS). Results suggested that they should move onto the next phase of testing - and this additional testing will likely take several more years.

The objective of this study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral doses of SGS518 compared to placebo when given to schizophrenia patients stable on antipsychotic medication.

In the placebo-controlled, blinded study, which was conducted at the Claghorn-Lesem Clinic in Houston, TX, the efficacy measure for cognitive changes during the course of treatment was the Brief Assessment of Cognition in Schizophrenia (BACS). A total of 20 patients aged between 18 to 55 years with a DSM-IV diagnosis of stable schizophrenia were enrolled in the study. Patients were randomised into one of two dose-escalating cohorts of ten subjects each (eight active, two placebo) and remained in residence for 15 days.

Patients were randomised to receive either a low dose-escalating regimen (60/180mg), a high dose-escalating regimen (120/240mg) or placebo. The total duration of treatment was 14 days. Cognition testing using the computerised BACS test was conducted prior to dosing, day 6 prior to escalation and after receipt of the last dose on day 13. The total duration of treatment was 14 days. SGS518 demonstrated dose proportionality with steady state reached within three days. Multiple doses of up to SGS518 240mg once daily were generally well tolerated and did not cause dose-limiting or significant toxicities.

A dose response pattern of improvement observed in the BACS endpoint demonstrated statistical significance at the high dose and no effect in the placebo group. SGS518 appears to be safe and well tolerated with preliminary evidence suggesting improvement in cognition using the BACS in patients with schizophrenia. SGS518 is believed to act by enhancing transmission of chemicals in the brain. Prior preclinical evaluation of SGS518 has shown it to be effective in behavioural studies of learning and memory. Saegis is developing SGS518 in co-operation with Eli Lilly as a treatment for CIAS with some support from the Stanley Medical Research Institute .

Source: Saegis Pharmaceuticals, Inc.


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