Actinogen’s Phase 2a clinical trial for depression treatment fails to meet primary endpoint, shares tank

Shares in drug development company Actinogen Medical (ASX: ACW) have plummeted following the results release of their Phase 2a clinical trial seeking a treatment for depression which has failed to meet its primary endpoint. 

In our fast-paced world, balancing a busy work schedule with life’s inevitable ups and downs can be challenging. Drugs for cognitive and mood disorders aim to manage stress and enhance well-being, offering hope for many. Companies like Actinogen are pursuing results to evaluate the efficacy of these drugs in supporting mental health although success is never guaranteed.

Actinogen focuses  on developing innovative therapies for cognitive and mood disorders. Xanamem, Actinogen’s lead drug candidate, targets the 11β-HSD1 enzyme to modulate cortisol levels in the brain, with the goal of treating conditions like major depressive disorder and Alzheimer’s disease. 

The study did not meet its main goal of improving attention scores but the Company drew attention to Xanamem still showing some benefits in reducing depression compared to a placebo. Despite the mixed results, the trial also confirmed that Xanamem was well-tolerated, with no serious adverse events reported, and the safety profile was consistent with previous trials. 

Dr Steven Gourlay, Actinogen’s CEO said: “The Actinogen team has done an outstanding job to deliver this trial aimed at acute symptom improvement in depressed patients suffering from cognitive dysfunction.

“Our primary objective remains the current XanaMIA Phase 2b trial designed to measure Xanamem’s ability to slow or halt Alzheimer’s disease progression over 36 weeks.”

The XanaCIDD trial was a randomised study with 167 participants who had both major depressive disorder (MDD) and cognitive issues. 

Dr Dana C Hilt, Actinogen’s Chief Medical Officer, said: “We will continue to examine these topline data in detail and the larger dataset to better understand the complete results and determine next steps for the depression program. The unexpected cognition placebo effect appears to have impaired the ability of Xanamem to show the pro-cognitive effects that we have observed in three previous studies.”

The trial results in depression management could enhance investor confidence and potentially drive up the Company’s financial position. Conversely, the failure to meet the primary cognitive endpoint may have tempered investor expectations with ACW shares hitting a low of $0.025 in early morning trade before recovering to around $0.033 which is still a 56% decline on their previous $0.076 close prior to the Xanamem data being released. 

For the June 2024 quarter, Actinogen reported operating cash outflow of $5.1 million, bringing their year-to-date operating cash outflow to $22.1 million.

As of 30 June 2024, the Company had $9.5 million in cash on hand.