Actinogen Medical (ASX:ACW) gains FDA approval for Fragile X Syndrome trial

• Actinogen Medical (ACW) has gained FDA approval to proceed with a clinical trial under the investigational new drug application
• The Phase 2 protocol will see around 50 patients with the genetic disorder Fragile X Syndrome treated using Xanamem over a 12-week period
• A letter of intent to operationalise the trial has been signed by Worldwide Clinical Trials, with $944,724 granted to enable the activation of clinical sites
• Actinogen Medical dropped 14.5 per cent, trading at 16.3 cents at 12:00 pm AEDT

Actinogen Medical (ACW) has gained FDA approval to proceed with a clinical trial under its Investigational New Drug (IND) application.

Actinogen is a biotechnology company developing a novel therapy for neurological diseases associated with dysregulated brain cortisol.

The company’s lead compound, Xanamem, has been investigated as a new therapy for Alzheimer’s Disease, Fragile X Syndrome, and other neurological diseases where reducing cortisol inside brain cells could have a positive impact.

The US Food and Drug Administration approved the company’s Phase 2 protocol, entitled “XanaFX: A Phase II Double-Blind, Randomized, Placebo Controlled trial, to Assess the Safety, Tolerability, and Efficacy of the 11β-HSD1 Inhibitor Xanamem in Treating Male Adolescents and Young Adults with Fragile X Syndrome.”

The Phase 2 protocol will see the genetic disorder Fragile X Syndrome treated using Xanamem. Around 50 patients will be enrolled over a 12-week treatment period, with results expected in 2023.

A letter of intent to operationalise the trial has been signed by Worldwide Clinical Trials, a research organisation specialising in neurological, paediatric, and rare diseases.

The sum of $944,724 for start-up activities has been granted to enable activation of clinical sites over a 60-day duration.

Actinogen Medical dropped 14.5 per cent, trading at 16.3 cents at 12:00 pm AEDT.