Awakn Life Sciences Receives Approval for Groundbreaking Phase III Ketamine-Assisted Therapy Trial
Clinical Trial to Evaluate Effectiveness of AWKN-001 for Treatment-Resistant Depression
Professor David Nutt, Chief Scientific Officer, Expresses Optimism About Trial Results
WEB Awakn Life Sciences, a leading biotechnology company, has announced that it has received clinical trial authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Phase III trial of AWKN-001, a ketamine-assisted therapy.
The Phase III trial, which follows successful Phase II trials, will enroll approximately 200 patients with treatment-resistant depression (TRD). The trial aims to evaluate the effectiveness and safety of a single treatment cycle of AWKN-001, which combines ketamine with psychotherapy.
Professor David Nutt, Chief Scientific Officer of Awakn, expressed his optimism about the trial.
"We are delighted to have received MHRA approval for our Phase III trial," said Professor Nutt. "Ketamine has shown great promise in treating TRD, and this trial will provide us with further evidence of its effectiveness and safety."
The trial will be conducted at multiple sites in the United Kingdom. The trial is expected to start in early 2023 and complete in 2025.
Awakn Life Sciences is committed to developing and delivering innovative treatments for mental health conditions. The company's mission is to improve the lives of people with mental health disorders by providing access to safe and effective therapies.
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