The Daily Populous Monday November 1st, 2021 night edition
Authored by themarketherald.com.au and submitted by a_Ninja_b0y

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Incannex Healthcare (IHL) spikes on the ASX today after landing important regulatory approvals to trial a psychedelic-based treatment for severe anxiety

Alongside researchers from Monash University, Incannex’s trial will test the safety and effectiveness of using psilocybin to treat General Anxiety Disorder

Psilocybin is a naturally-occurring psychedelic found in certain species of fungi often known simply as “magic mushrooms”

Meanwhile, Incannex says it is progressing talks with the US FDA around a potential Investigational New Drug (IND) application for the psychedelic treatment therapy

Shares in Incannex Healthcare are up 4.11 per cent and trading at 38 cents each

Incannex Healthcare (IHL) has spiked on the ASX today after landing important regulatory approvals to trial a psychedelic-based treatment for severe anxiety.

At the same time, the company has progressed talks with the US Food and Drug Administration (FDA) around potentially receiving Investigational New Drug (IND) status for the psychedelic treatment therapy.

Incannex this morning said the Monash University Human Research Ethics Committee (MUHREC) had greenlit the second-phase clinical trial to treat General Anxiety Disorder (GAD) with a mixture of psilocybin and specialised therapy.

Psilocybin is a naturally-occurring psychedelic found in certain species of fungi often known simply as “magic mushrooms”.

Incannex’s clinical trial will be the first in the world to examine the safety and effectiveness of using this psychedelic to help treat GAD.

Monash University Head of Clinical Psychedelic Research Paul Liknaitzky, who is leading the trial, said this was an exciting step for the emerging field of psychedelic medicine.

“This is a solid step in the development of what we hope will be a highly effective treatment for people suffering under the weight of severe anxiety,” Dr Liknaitzky said.

Interestingly, it’s not just the trial patients that will be administered psychedelics under the Incannex trial; the study has been approved to give trial therapists the option to experience the effects of psilocybin under controlled conditions as part of their training.

“For the first time ever, we’re able to provide supported psilocybin sessions to research trial therapists to better equip them to accompany our clinical participants through profoundly unfamiliar terrain, potentially improving treatment outcomes,” Dr Liknaitzky said.

The study is slated to kick off with patient recruitment early next year.

Incannex said it included an overview of its psychedelic GAD treatment program in a pre-IND meeting with the FDA.

While the IND application process is still in its early stages, Incannex said responses received from the FDA so far — both written and via a recent teleconference — were “positive, constructive, and supportive”.

According to Incannex, the FDA confirmed the therapeutic strategy for psilocybin-assistant therapy for GAD was appropriate. Moreover, the FDA allegedly gave Incannex some guidance on the company’s proposed long-term development strategy as far as landing successful FDA approval and market authorisation is concerned.

Incannex said the FDA feedback will help shape the next stage of its phase-two trials, which the company plans to use as its opening study for its IND application.

Shares in Incannex Healthcare were up 4.11 per cent and trading at 38 cents each at 11:35 am AEDT. The company has a $441.1 million market cap.

gravitywellll on October 31st, 2021 at 15:32 UTC »

I’m diagnoses psychosis and I’ve micro dosed. It doesn’t make things worse but I’m not convinced it helps either. Hard to tell. It doesn’t ever reach a noticeable head or body high, it’s just a micro dose. It helps compared to stuff like Prozac or Zoloft. And just dosing once ever week or two is all it takes.

I haven’t had a serious episode in over a year but that’s not just because of the micro dosing. My whole life changed bc of Covid and I was able to purge some negative things in my life that helped. Environment plays a huge role and I think a lot of the time I got prescribed things as a crutch to cope when my environment problems couldn’t be helped. Sometimes a crutch makes all the different though.

If anyone has questions I can try to answer. No It’s not legal, I’m in the US.

Cloakmyquestions on October 31st, 2021 at 12:57 UTC »

Are there some psych disorders where the psylo could make things worse?

unfnknblvbl on October 31st, 2021 at 12:03 UTC »

As an Australian with GAD (along other mental health issues), I welcome this news with open arms. Even if there's nothing behind the anecdotes about psilocybin being good for mental health issues, it's good that it's being taken seriously instead of just "hurrr drugs are bad" and sidelined.