Actinogen Obtains FDA Approval to Commence Alzheimer’s Disease Clinical Trial

Actinogen Medical announced today (3/01/17) that the US Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application to recruit for the XanADu, Phase II for the clinical trial of Xanamem™ which will target patients with mild Alzheimer’s disease, in the US.

The trail is tilted: XanADu: A Phase II Double-Blind, 12-Week, Randomised, Placebo-Controlled Study to assess the safety, tolerability and efficacy of Xanamem™ in subjects with mild dementia. XanADu will enrol 174 patients at clinical sites across the USA, the UK and Australia. The trail is registered on www.clinicaltrials.gov.

The IND approval follows an extensive in-depth review by the FDA of past research and clinical data on Xanamem™ and of Phase II of the XanADu clinical trial. This IND approval provides strong endorsement by the FDA for Xanamem™ development in Alzheimer’s disease. Xanamem™ is different from the existing products on the market for Alzheimer’s disease. Xanamem™ has been specifically designed to block excess production of cortisol (the stress hormone), in the areas of the brain most affected by Alzheimer’s disease. The idea of raised cortisol has been strongly associated with Alzheimer’s disease, and with research has now become an important target for treating the disease.

Dr Bill Ketelbey, CEO of Actinogen Medical said: “We are delighted with the IND approval as it represents a major milestone for Actinogen Medical in the development of Xanamem™ in the treatment of Alzheimer’s disease. New treatment options are desperately needed for Alzheimer’s disease and this IND approval is a significant step forward in demonstrating that Xanamem™ is an effective treatment option for this devastating disease.”

Actinogen is currently awaiting to receive similar approvals from authorities in Australia and the UK within the next two months, and for the trail to begin actively recruiting patients by Q2, 2017.

XanADu, is currently the largest global Alzheimer’s disease study conducted by an Australian biotech company. Nearly half planned sites have been scheduled for the US and will represent around 50% of the market for Alzheimer’s medication.