• Actinogen doubled on positive Phase 2a results for Xanamem
  • Xanamem’s durability leads to a Phase 2b Alzheimer’s trial
  • PharmAust’s monepantel showed promising ALS results

 

Actinogen doubles on promising Phase 2a trial data

Actinogen Medical (ASX:ACW)’s stock price more than doubled this morning after announcing promising results from its XanCIDD phase 2a trial.

The latest data shows that ACW’s lead drug, Xanamem, has consistently helped improve symptoms of depression across various endpoints at a 10mg dose.

This supports the conclusion that Xanamem is effective in managing brain cortisol levels, and that it has antidepressant activity.

The trial results highlighted several key points.

The Montgomery–Åsberg Depression Rating Scale (MADRS) score, a common measure for depression severity, improved significantly with Xanamem treatment, and these improvements were observed in five out of six patient groups.

Additionally, the Patient Global Impression of Severity (PGI-S) data, another measure of clinical function in depression, corroborates the positive MADRS findings.

The new analysis also showed that, at Week 10, there was a 50% higher rate of depression remission with Xanamem compared to the placebo. This suggests that Xanamem provides a durable therapeutic effect, lasting beyond the end of the six-week treatment period.

This durability matches how cortisol affects the brain’s biology, suggesting that Xanamem may be helping to manage stress in the brain for a long time.

“The data on depression are incredibly good news for Actinogen, and for the many patients who may benefit from Xanamem in the future,” said Actinogen’s CEO, Dr Steven Gourlay.

“While the anti-depressant market is competitive, Xanamem’s safety profile stands it apart from the competitors and the durability of benefit seen is intriguing.”

Actinogen will now be focusing on enrolling participants for the XanaMIA Phase 2b trial, which aims to assess Xanamem’s potential to slow or halt Alzheimer’s disease progression over 36 weeks.

Interim results from this trial are expected in mid-2025.

 

PharmAust’s Monepantel shows strong ALS results

PharmAust (ASX:PAA) has shared promising interim results from the ongoing Open-Label Extension (OLE) study for Amyotrophic Lateral Sclerosis (ALS) using its drug, monepantel (MPL).

The study showed that MPL, administered at a daily dose of 10mg/kg, continues to be well tolerated and effectively slows disease progression while improving survival rates.

Compared to untreated ALS patients from a historical database, those on MPL experienced significantly longer survival, an 80.3% reduced risk of death, and a 43.2% slower rate of functional decline.

Crucially, 56% of the patients showed no functional decline at all.

Some patients have been on MPL for up to 23 months, and the ongoing positive results are encouraging for the upcoming Phase 2/3 study within the HEALEY ALS Platform Trial, which is expected to start enrolling participants next quarter.

 

 

 

At Stockhead we tell it like it is. While PharmAust is a Stockhead advertiser, it did not sponsor this article.

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