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- Biotech company Actinogen Medical (ACW) has announced two clinical trials and a $10.9 million capital raising
- A phase two clinical trial will evaluate Actinogen’s Xanamem treatment’s safety and efficiency in treating anxiety, sleep and behavioural problems are related to Fragile-X syndrome (FXS)
- Additionally, Actinogen’s new XanaMIA phase two clinical trial aims to prove the safety, tolerability and efficacy of Xanamem on patients with mild cognitive impairment due to Alzheimer’s
- Meanwhile, the company is aiming to raise $6 million in a placement at 2.2 cents per share
- And a one-for-five non-renounceable rights issue offer to shareholders is planned to raise an additional $4.9 million
- On the market this afternoon, Actinogen is down 14.3 per cent and is trading for 2.4 cents per share
Biotech company Actinogen Medical (ACW) has announced two clinical trials and a $10.9 million capital raising.
XanaFX Study
Actinogen is planningto undertake a phase two clinical trial using Xanamen for Fragile X syndrome (FXS) patients.
FXS is a genetic disorder, usually diagnosed at around three to five years of age, causing mild-to-moderate intellectual disability. It affects both males and females, however, females usually have milder symptoms.
Previously, the company has trialled Xanamen in Alzheimer’s disease and since has received interest in evaluating the drug across a range of medical conditions with chronically raised cortisol.
The phase two clinical trial, known as the XanaFX study, will evaluate Xanamem’s safety and efficiency in treating anxiety, sleep and behavioural problems which are related to FXS.
Anxiety and behavioural problems associated with the disease has a significant impact on FXS patients’ daily lives.
The XanaFX study will trial the drug on approximately 40 males, aged between 12 and 18, with FXS. The study also will test the safety and tolerability of Xanamem with two different doses.
“To the company’s knowledge this is the first study to target cortisol inhibition as a treatment for anxiety, sleep and behaviour problems in FXS patients,” Actinogen said.
Additionally, Actinogen plans to submit an orphan drug designation and rare paediatric disease designation to the United States Food and Drug Administration for Xanamem in FXS.
This study is fully funded.
XanaMIA
The company is continuing to focus on the development of Xanamem as a potential treatment for Alzheimer’s disease with another study.
Actinogen’s new XanaMIA phase two clinical trial aims to show the safety, tolerability and efficacy of Xanamem on patients with mild cognitive impairment due to Alzheimer’s.
These patients are at the early stages of Alzheimer’s and presents a significant unmet medical need, with no effective treatment currently available.
The company will start recruiting patients in the early months of 2021 and the trial is expected to be completed within 24 months after commencement date.
Proceeds from the capital raising will be used to fund the XanaMIA study.
Capital Raise
Actinogen is aiming to raise $10.9 million through a placement and entitlement offer.
Under the placement, the company will issue around 272 million shares at 2.2 cents per share to raise $6 million.
In addition, the entitlement offer includes a one-for-five offer to existing shareholders to raise $4.9 million.
CEO and Managing Director, Dr Bill Ketelbey, is pleased to embark on this new trial program and is excited to announce FXS as a new indication for Xanamen.
“The company is committed to advancing Xanamem’s clinical development to find an effective treatment for a number of devastating medical conditions and the upcoming FXS trial expands the potential clinical applications for Xanamem,” he said.
“In addition, significant support has been demonstrated by existing shareholders and new investors to fund a phase two trial targeting early stages of Alzheimer’s disease, and we are pleased to announce an entitlement offer to eligible shareholders on the same terms,” he added.
On the market this afternoon, Actinogen is down 14.3 per cent and is trading for 2.4 cents per share at 1:52 pm AEDT.
