Remedi Therapeutics

Actual: Jan 1, 2008

CX157 Phase 1 programme completed under CeNeRx BioPharma: 65 healthy volunteers across multiple studies. Compound was safe and well-tolerated. Rapid absorption (Tmax ~0.5h), plasma half-life ~6h. PET imaging confirmed selective MAO-A occupancy in human brain (Nature Neuropsychopharmacology 2010).

Why it matters: Comprehensive Phase 1 safety/PK data for the RIMA component is already in hand — de-risks the combination development significantly vs. novel RIMA compounds. Brain penetration and MAO-A target engagement confirmed by PET.

Actual: Sep 1, 2008

CX157 Phase 2 MDD trial (NCT00739908) completed under CeNeRx: 360 patients (182 CX157, 178 placebo). Failed primary endpoint (p=0.58). Post-hoc analysis suggested site-based MADRS scoring variability rather than drug inefficacy. Separately, Phase 2 TRD trial (NCT01246908) enrolled 285 patients.

Why it matters: Although CX157 failed as a standalone antidepressant, the extensive safety dataset from 360+ MDD patients is invaluable for the Remedi combination approach. The failure as monotherapy is actually consistent with the hypothesis that CX157's value is as an MAO-A enabler for tryptamine oral bioavailability, not as a standalone therapeutic.

Actual: Jun 1, 2010

CX157 tyramine pressor study (NCT01633437) completed: 12 subjects, CX157 125 mg BID was NOT associated with a tyramine reaction. Confirms no dietary restrictions required — a critical differentiator from irreversible MAOIs and traditional ayahuasca harmaline.

Why it matters: Eliminates the "cheese effect" safety concern that has historically limited MAOI adoption. For a pharmahuasca formulation, this means patients would not need the dietary restrictions required with traditional ayahuasca or pharmaceutical MAOIs.

Actual: Jan 1, 2022

Remedi Therapeutics LLC formed. Tom Spector (PhD Yale Pharmacology, ex-Wellcome/GlaxoWellcome) joins as Scientific Partner and Principal Inventor. Company acquires rights to develop CX157 in combination with tryptamine psychedelics.

Why it matters: Repurposes a well-characterised RIMA with extensive human safety data (~700+ subjects) for a novel application: enabling oral psychedelic therapy. Spector brings 50+ years of drug development experience from Wellcome/GSK.

Actual: Nov 17, 2023

PCT patent WO2024108195A1 filed: "Combinations of monoamine oxidase inhibitors and serotonin receptor agonists and their therapeutic use." Covers CX157 + DMT, 5-MeO-DMT, DPT, psilocin, psilocybin, and deuterated variants. Published May 23, 2024. Claims micro-, psycholytic, and psychedelic dosing regimens.

Why it matters: Broad IP covering the entire RIMA + tryptamine pharmahuasca concept. If granted, creates a defensible position for pharmaceutical-grade oral psychedelic formulations across multiple tryptamines and indications (MDD, TRD, PTSD, anxiety, OCD, neurodegeneration, pain, inflammation).