EMD releases positive MDMA trial data for PTSD

Today, our psychedelic assisted therapy Investment, Emyria (ASX: EMD) released positive results from its ongoing trial testing the efficacy of MDMA assisted therapy as a treatment for moderate to severe PTSD.

The trial results look impressive to us - showing a statistically significant and sustained improvement in quality of life as measured by ReQoL-10 scores.

ReQoL stands for Recovering Quality of Life which is a questionnaire that has been developed to assess the quality of life for people with different mental health conditions - and in this case PTSD.

The results show ReQoL scores increasing by an average of 23.5 points from Baseline to the 3-month follow-up:

(Source)

Meanwhile PTSD symptoms (measured by PCL-5 scores) decreased by an average of 29.6 points from baseline to 3-month follow-up:

(Source)

One of the most interesting aspects of the trial data was the sustained improvements in both PTSD symptoms and quality of life even three months after completing treatment.

In short: the treatment has dramatically improved PTSD patients’ overall quality of life over a sustained period.

Data like this helps build the case for EMD’s treatment in the eyes of regulators and the general public - there are an estimated 800,000 Australians who suffer from PTSD.

We covered early results from the PTSD trial in our latest EMD note below:

Data shows EMD’s PTSD program is working, Australia leading the US

Today’s EMD update also gave us a taste of what could be to come - discussing EMD’s potential to deliver psilocybin treatments for treatment resistant depression.

This could be one avenue which EMD pursues in order to scale its business.

How does this news impact our EMD Investment Memo?

We see this news as moving EMD closer to completing the trial, which is our #1 Objective from our EMD Investment Memo:

Objective #1: Gather important data from MDMA mental health trial

We want to see EMD deliver its MDMA assisted therapy. EMD has already recruited its first patient and secured key approvals from the Office of Drug Control and Therapeutic Goods Administration.

Milestones
✅Begin treatment on first patient (MDMA)
🔄Complete patient recruitment for Phase 2b trial (MDMA)
🔲Complete Phase 2b trial for MDMA

Source: 4 September 2023 EMD Investment Memo

What’s next for EMD?

We are increasingly looking ahead to EMD’s ability to scale its therapy clinics after new Executive Chairman Greg Hutchinson took the reins of the company after investing $1M in the most recent EMD raise:

EMD completes raise, Chairman invests $1M

Hutchinson is well-known for his significant success as CEO of Sonic HealthPlus over the past 14 years.

Sonic HealthPlus is part of Sonic Healthcare (ASX: SHL) and the company re-rated from a share price of ~$12 20 years ago to a peak share price of $47 at the end of 2021 - it's currently a $13BN company.

Sonic HealthPlus is Australia’s leading provider of occupational healthcare and general medical services so Hutchinson is well versed in scaling medical clinics.

So we see Greg’s new role as leveraging his ability to quickly scale EMD’s business.

Looking ahead, we want to see the following bits of progress for EMD:

🔄Animal study results for fast-acting MDMA analogue

EMD is developing its own analogues (modified versions of the drug that work better). These tests are currently being run on animals and we want to see if EMD publishes positive results here.

🔄Approval for ketamine assisted therapy protocol

EMD has a pending application for a ketamine assisted therapy trial.

🔲Secure a major payer partnership (we see this as a major catalyst)

If EMD is able to secure a payer for its treatments, we think this would be a major catalyst for the company.