Emryria receives endorsement from NHMRC ethics committee
Today, our psychedelic treatment and care delivery Investment, Emryia (ASX: EMD) announced that its lead psychiatrists had received endorsement from an NHMRC ethics committee allowing them to advance their Authorised Prescriber (AP) applications with the Therapeutic Goods Administration (TGA).
Why is this important?
The development today allows EMD to progress the applications to final consideration.
More psychiatrists operating under the AP system means EMD can more quickly scale its operations.
The regulatory regime EMD is operating under in Australia operated by the TGA requires EMD’s psychiatrists to meet stringent standards to administer the psychedelic treatments.
EMD has previously already secured 16 AP approvals for its cannabinoid program.
EMD has recently dosed its first patient in its MDMA trial - which we’re expecting good results from given the latest MAPS study data.
Read more about EMD in our latest note.
What’s next for EMD?
EMD has a heap of newsflow to come…
MDMA-AT Phase 2b patient recruitment updates 🔄
We want to see EMD recruit all 72 patients into the trial so that we will have a timeframe on results.
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 key approvals for psilocybin use 🔄
EMD has a pending application for psilocybin use in an assisted therapy trial.
Recommence Phase 3 trial of low-dose CBD for stress & anxiety 🔄
EMD is part-way through a Phase 3 trial for a low-dose CBD product targeting Schedule 3 over-the-counter use in Australia.
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. Any agreement that provides financial support to patients to pursue these treatments would be significant validation for EMD and its strategy.
