Actinogen Medical is an ASX-listed Australian biotech developing lead asset Xanamem, a specific 11beta-HSD1 inhibitor designed to treat cognitive impairment that occurs in chronic neurological and metabolic diseases.
On 1 October 2019, Actinogen announced results from its Phase I XanaHES trial (Xanamem 20mg daily in healthy elderly subjects). This trial was designed to assess the safety of high doses of Xanamem but, in addition to standard safety endpoints, Actinogen included exploratory endpoints to assess the effect on cognition. A positive surprise was the finding that three of six domains in Cogstate Cognitive Test Battery showed an improvement in cognition. This followed results from the Phase II XanADu trial in AD patients announced in May 2019. The safety of the drug was confirmed and the data showed Xanamem was pharmacologically active. However, the 10mg dose of Xanamem (half that used in the XanaHES trial) was not effective in the efficacy endpoints. Following the positive XanaHES results, Actinogen indicated that it will analyse the data and make a decision on future steps once all analyses are complete and results from other supporting trials are available.
The unmet need in Alzheimer’s disease is vast and the size of the market has attracted interest from almost every player in CNS drug R&D over the past 30 years with very limited success so far. With so many late-stage failures, we believe that ‘non-mainstream’ technologies, such as Xanamem, may attract renewed interest from potential partners.