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Actinogen Medical Demonstrates Novel Approach to Treating Cognitive Impairment

Announced in October 2019, results from the XanaHES trial showed significant improvement in cognition amongst trial participants.

XanaHES is a Phase I, randomized, single-blinded, central reader blinded, placebo-controlled dose escalation study. It was conducted to assess the safety and tolerability of Xanamen, a novel drug designed to inhibit cortisol production in the brain, to treat cognitive impairment and potential treatment for Alzheimer’s disease, mood disorders and schizophrenia.

The results demonstrated statistically significant cognitive improvements in health elderly subjects dosed with 20 milligrams of Xanamen daily in the XanaHES dose escalation study. Serum cortisol level showed statistically significant reduction following treatment of 20 milligrams of Xanamem.

Daily dose of 20 milligrams of Xanamem exhibited a good safety profile over the 12 weeks of treatment, with no reports of serious adverse events.

Professor Micheal Woodward from Austin Health in Melbourne and one of the leading investigators in the XanADu trial said:” It is just so pleasing and encouraging to see this positive efficacy data for Xanamem, following the disappointment of the XanADu trial. There have been so many past failures with the development of Alzheimer’s drugs, so these promising results offer renewed hope for a treatment breakthrough for this devastating disease”.

Done previously, the XanADu trial to assess the safety, tolerability, and efficacy of 10 milligrams daily of Xanamem on subjects with mild dementia due to Alzheimer’s disease showed that it was safe and altered the cortisol pathway, however, did not demonstrate an improvement in cognition.

The XanaHES trial also included an exploratory assessment of cognition to evaluate the cognitive efficacy of Xanamem, using the industry standard Cogstate Cognitive Test Battery.

Actinogen CEO Dr Bill Ketelbey said: “As we gather and analyse more date from XanaHES and other ongoing studies, we are building a much clearer picture of Xanamem’s pharmacology, potential efficacy, safety, and mechanism of action; all of which will aid substantially in planning the future clinical development and commercialization strategy for the drug.”

“We look forward to sharing Actinogen’s future development plans for Xanamem once they have been reviewed alongside these very pleasing results.” [APBN]