The Actinogen Medical Ltd (ASX: ACW) share price has been a strong performer on Wednesday morning.
At the time of writing, the shares of the biotechnology company developing an innovative treatment for cognitive impairment are up 17% to 17 cents.
This means the Actinogen share price is now up an incredible 750% since the start of the year.
Why is the Actinogen share price charging higher?
Investors have been bidding the Actinogen share price higher today after it provided an update on its dealings with the US Food and Drug Administration (FDA).
According to the release, the company has received written supportive US FDA advice in response to its Pre-Investigational New Drug Application (Pre-IND) submission for its fragile X syndrome (FXS) program. FXS is an inherited genetic disease passed down from parents to children that causes intellectual and developmental disabilities.
Actinogen sought a Pre-IND meeting with the FDA to discuss its lead molecule, Xanamem, and the FXS clinical program. Today's release reveals that the advice received indicates that the data package and trial design proposed for the IND submission would be sufficient, subject to final review of all supportive documentation submitted. As a result, the company plans to file the full IND submission during the third quarter of 2021.
In addition, Actinogen advised that the two parties are also in agreement on the proposed Phase II adolescent patient population to be studied. The Phase II XanaFX study will be a randomised, placebo-controlled, double-blind, 12-week trial investigating the safety and efficacy of Xanamem in male adolescents who suffer from FXS.
The study will be conducted in Australia and is expected to commence in the fourth quarter of this year.
Actinogen's CEO and MD, Dr Steven Gourlay, commented: "The FDA's positive Pre-IND advice for FXS marks a significant milestone in the clinical development of our second disease program. It provides greater confidence that we will obtain support from the FDA for the investigation of Xanamem in this disease that has a high unmet medical need for effective therapies."
"There are no currently approved therapies for FXS. The Company is advancing the planning for its Phase II XanaFX trial which is expected to commence by the end of the year. Actinogen is now positioned to progress its clinical programs with multiple Phase II trials and is well funded to advance the development pipeline," he concluded.
