PDP-19: [Funding] Next Gen Empathogens

Applicants: Dr. Greg Dwulet, Dr. Matthew Cowan, Dr. Scott Cameron Deal Shepherd: Steven Fülle

Overview

The goal of this project is to develop a new class of MDMA prodrugs to overcome the safety limitations and regulatory hurdles of MDMA-assisted therapy, such as cardiovascular risks, neurotoxicity, and abuse potential.

The project's novelty lies in building an entirely new approach to prodrugs using metal-coordination complexes. This method involves coupling an amino acid to MDMA and then binding a biocompatible metal (e.g., zinc) to the amino acid. This creates a two-step release mechanism. The central hypothesis of this research is that this unique mechanism will allow for greater temporal control over the drug's release. This could lead to a safer pharmacological profile with a more gradual onset and fewer side effects.

If successful, this platform could be generalized to improve the safety and tunability of other centrally active small molecules, opening new avenues for prodrug development across therapeutic areas.

Research Plan, Timeline, and Budget

The project is structured as a single proposal with a total budget of $50,000, which will be disbursed in two tranches tied to milestone completion.

$30,000 Budget Deliverables:

• Phase 1 (4 months): Synthesize and characterize a library of 5-10 MDMA-derived coordination complexes.
• Phase 2 (2 months): Screen the complexes for chemical and metabolic stability to identify 3-5 promising candidates to advance.
• Phase 3 (2 months): Conduct preliminary ADME (absorption, distribution, metabolism, excretion) and toxicology testing on the top candidates.

$50,000 Budget Deliverables:

• Includes all goals of the $30k budget.
• Expands the initial synthesis phase, allowing for a larger library of compounds.
• Phase 4 (2 months): Conduct in vivo pharmacokinetic (PK) validation in rats to demonstrate modulation of drug release kinetics.
• Allocates funds for IP costs, such as converting the existing provisional patent.

The budget primarily covers a part-time salary for Dr. Cameron, lab supplies, and costs for outsourcing biological assays to a CRO (Pharmaron). Dr. Dwulet and Dr. Cowan do not require salaries.

Signed MoU and Benefits to PsyDAO

PsyDAO and University of Canterbury have executed a signed Memorandum of Understanding for this project. Under the MoU, PsyDAO receives:

• Exclusive license to the foundational MDMA-metal complex IP from University of Canterbury.
• Right to tokenize this project as an IPT, enabling community participation and governance.
• Right of first refusal to partner on any future IP-producing research arising from this work.
• Regular progress updates and milestone reports shared with the PsyDAO community.
• Platform technology ownership that could extend to other psychedelic compounds (mescaline, ibogaine, etc.).

Funding requested from PsyDAO: $50,000

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Please visit the following link to view the full proposal details: https://docs.google.com/document/d/1nhRO_d2MzEyvEfcCSeSJiezQQoVuecKo6ozfFfmy2Z8/edit?usp=sharing