Estimated to affect 1 in every 4,000 boys, there is currently no treatment approved in the world for cognitive disorder Fragile X Syndrome but that could change in the coming years with biotech company Actinogen (ASX: ACW) confirming a manager to oversee the Phase 2 trials of its XanaFX clinical trials. 

Fragile X Syndrome is a genetic disorder most prevalent in young boys which impairs their intellectual capacity with slight distortion of their physical appearance also. The disorder is commonly confused with autism with similar symptoms around social interactions, behavior and delayed speech but unlike autism, FXS is linked to an impairment of the X chromosome. 

Hoping to improve the life quality of those suffering from FXS, Actinogen is set to progress with their trials of Xanamem, appointing clinical research organisation Worldwide Clinical Trials to recruit and conduct the XanaFX Phase 2 trials. 

“We are pleased to finalise a full-service contract with Worldwide Clinical Trials for the management of our Phase 2 Fragile X Syndrome (FXS) trial, the scope of which has recently been expanded to include a larger number of participants and with investigative sites across the USA, UK and NZ in addition to Australia,” said Actinogen CEO, Dr Steven Gourlay. 

“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.” 

Worldwide Clinical Trials will recruit, conduct and manage the trials for a fee of $13.6 million with oversight from Actinogen with the collaborators aiming to release Phase 2 trial results in 2023. 

The XanaFX trial will study cognition, anxiety, sleep and behavioural problems in male adolescents and young adults possessing the full genetic features associated with FXS. 

Funding for the trials will come from Actinogen’s strong balance sheet where the Company had $22.2 million in the bank as of 31 December 2021 following a successful $13.3m capital raise at $0.135 per share. 

In separate trials, Actinogen is also conducting analysis of Xanamem® on disease modifying biomarkers from a prior Phase 2 study conducted in 185 patients with mild Alzheimer’s Disease. Those results are expected to be reported in the second half of CY2022.