Yahoo

Actinogen Medical: XanaMIA results due in November

Actinogen Medical Ltd managing director and CEO Dr Steven Gourlay talked with Proactive about the company's progress toward the topline results from its pivotal XanaMIA Alzheimer's disease clinical trial, which are expected in November.

The company made significant progress during the quarter, with the final patient visit completed in September. The trial involved 247 patients across two countries and included a 36-week treatment period, generating a substantial volume of clinical data that is now being cleaned and finalised ahead of the readout.

Gourlay also discussed a new scientific paper examining the rationale for controlling cortisol in the brain and the potential role of Xanamem. He said excess cortisol levels are strongly associated with Alzheimer's disease and its progression, while also pointing to previous company data showing activity in depression.

The company ended the period with a pro-forma cash position of around A$21.9 million, which gives Actinogen flexibility as it approaches the clinical results and considers potential strategic partnerships.

If the November results are positive, the company will look to engage with a global pharmaceutical partner with established clinical trial and commercial capabilities.

Visit Proactive's YouTube channel for more interviews and market updates. If you found this video useful, give it a like, subscribe to the channel and enable notifications so you don't miss future content.

#ActinogenMedical #Xanamem #XanaMIA #AlzheimersDisease #AlzheimersResearch #ClinicalTrials #Biotechnology #Biotech #DrugDevelopment #HealthcareInvesting #ASX #ACW #Pharmaceuticals #Neuroscience #ProactiveInvestors

00:00 Dr. Steven Goulay

And why we have belief that this clinical trial uh in November has a really good chance of reading out uh very positively.

00:13 Jonathan

Actinogen medical closed the September quarter with its pivotal Xanamem Alzheimer's disease trial on track for top-line results in November and a pro-forma cash position of around 21.9 million.

00:26 Jonathan

With me to discuss the quarter's milestones is managing director and CEO, Dr. Steven Goulay. Steven, good to see you again.

00:33 Dr. Steven Goulay

Uh Hi, Jonathan. Thanks for having me.

00:35 Jonathan

It's a pleasure. So, yeah, talk us through these key achievements for the quarter, especially as we come to this November deadline.

00:43 Dr. Steven Goulay

Yeah, so, uh, look, we're very excited to detail, you know, the pretty amazing progress over the last few months as we get closer to the clinical trial result. The top line results in November. It's no trivial exercise doing a pivotal trial.

01:00 Dr. Steven Goulay

247 patients across two countries, a 36 week long treatment period, many visits, a lot of data, all of which uh has culminated now in the last patient visit uh in September, and of course, the data will be cleaned and scrubbed, so we have super high quality data when we finally get to open the envelope, if you like in November. But until then, the trial results are completely confidential.

01:31 Dr. Steven Goulay

Nobody knows the results. This is what a double blind randomized trial does. So, yeah, very excited about that.

01:38 Jonathan

Yeah, we're not November's not far away now, but uh uh, in in the meantime and a new scientific paper, clinical and translational neuroscience. Um, it's looking at how Zana or Xanamem controls cortisol in the brain. How is how important is that paper to you?

01:58 Dr. Steven Goulay

Yes. So um, you know, we were uh a number of authors from the company but also a very important professor from Edinburgh, Jonathan Sele who's a real expert in 11 beta21 in ambition this is the target cortisol synthesis. high of the rational between tackling cortisol and particularly the the really attractive way of being able to inhibit this enzyme to inhibit tissue cortisol synthesis,

02:27 Dr. Steven Goulay

control uh excess levels of cortisol in the brain that are so strongly associated with Alzheimer's and the progression of Alzheimer's and probably many other diseases. And we showed in our own data, depression data as well, some activity as an anti-depressant. So it's the first time it's really detailed why Xanamem is such an intelligent and appropriate approach to cortisol.

02:45 Dr. Steven Goulay

And why we have belief that this clinical trial uh in November has a really good chance of reading out uh very positively.

02:54 Jonathan

Mhm. And the quarter also uh delivered 21.9 million uh proformer cash position. Um talk talk us through the options that gives you as as you approach the results and beyond.

03:06 Dr. Steven Goulay

Yes. So the board and the and the management have been striving to create as much optionality as possible. Uh and we raised a bit of money earlier in the year. Um and then can together with the option exercises of some unlisted options, uh which brought in another 5 million and the tax credit due at any time. You know, that's the proformer of 21.9, which is a great position to be in going into results.

03:32 Dr. Steven Goulay

We're not in a hurry to do anything. Uh we have money to talk to the relevant strategic potential strategic partners who could be very critical, of course, to the future of the company and the development of Xanamem. If we do have the holy grail for Alzheimer's in our hands in November, the right thing to do, obviously, is to recruit a global pharmaceutical company with established uh clinical trials capabilities and and commercial launch capabilities as a partner. And uh we'll be going straight into those discussions.

04:06 Dr. Steven Goulay

And we have the optionality to uh hold back on phase three spending, uh discuss the design of the trials and the partnership with those people and then um move forward as we need to.

04:16 Jonathan

Yeah, Stephen, lots to look forward to especially as November's only a few weeks away as well. Um thanks for your time this morning and uh yeah, good luck with it all.

04:24 Dr. Steven Goulay

Thanks so much.

Mobilize your Website
View Site in Mobile | Classic
Share by: