- Actinogen Medical (ACW) appoints a trial manager for its XanaFX phase-two trial in adolescent boys and young adults with Fragile X Syndrome (FXS)
- Clinical research organisation Worldwide Clinical Trials will manage the recruitment of participants and conduct and implement the trial
- Worldwide began operating the XanaFX trial and start-up activities after signing a letter of intent with Actinogen in November 2021 worth $944,724, in advance of negotiating and signing a full work order
- Today’s deal will see the company paid $13.6 million under a full-service contract that appoints Worldwide to globally manage the XanaFX trial
- ACW shares steady at 11.5 cents
Actinogen Medical (ACW) has officially appointed a trial manager for its XanaFX phase-two clinical trial treating adolescent boys and young adults with Fragile X Syndrome (FXS).
The company said clinical research organisation Worldwide Clinical Trials will be responsible for managing the recruitment of participants and conducting and implementing the trial.
Worldwide, a global clinical research organisation specialising in neurological, paediatric and rare diseases, had already begun trial start-up activities after signing a letter of intent with Actinogen in November 2021 worth $944,724, in advance of negotiating and signing a full work order (WO).
Today’s WO agreement will see Worldwide paid a further $13.6 million under a full-service contract that appoints it to globally manage the XanaFX trial, with oversight from Actinogen.
The XanaFX study will assess cognition, anxiety, sleep and behavioural problems in male adolescents and young adults possessing the full genetic features associated with FXS.
The randomised, placebo-controlled 12-week trial will involve 75 patients in North America, Great Britain, Australia and New Zealand receiving five milligrams (mg) and 10 mg oral doses of Actinogen’s novel small-molecule drug Xanamem.
“There are currently no treatments approved anywhere in the world for FXS, and the commencement of Actinogen’s key XanaFX trial is another important step in our quest to help make a material difference to the quality of life for people and their families living with FXS,” Actinogen Managing Director and CEO Dr Steven Gourlay said.
The company anticipates trial results in 2023.
ACW shares were steady at 11.5 cents at 3:07 pm AEDT.