Serotonergic Psychedelic Mechanism
Our approach to developing novel therapeutics is inspired by decades of psychedelic research demonstrating promising results for a variety of mental health conditions. Our proprietary serotonergic psychedelic drug candidates aim to deliver safe, fast-acting, short duration therapies that provide lasting benefits to patients underserved by available treatment options.
Our development pipeline is focused on drug candidates that target serotonin (5HT-2A), a neurotransmitter known to regulate mood, appetite, sleep, learning, memory, and many other biological and physiological functions. Due to these key functions, serotonin reuptake inhibitors (SSRIs)—the most commonly prescribed drugs to treat depression—modulate serotonin receptor concentrations in the brain. However, SSRIs often have delayed and/or poor response rates, notable side effects, and require continuous dosing.
INDICATIONS
Postpartum Depression
We plan to evaluate our lead clinical-stage drug candidate, RE104, in postpartum depression (PPD), which is estimated to affect about 10-15% of all mothers of newborns. PPD is a form of major depression that can severely impact women and their families. Women suffering from PPD often experience significant changes in mood, appetite and sleep contributing to feelings of hopelessness, lack of concentration, loss of energy, poor self-esteem and maternal disinterest.
The only regulatory approved therapy indicated for PPD requires significant time away from family and newborn. SSRIs, which are often prescribed off-label, take a long time for onset and only show limited efficacy, representing a concern for the safety, well-being and long-term development of the child.
We believe there is a significant unmet need for a safe, fast-acting, short duration therapy for women who suffer from PPD. In addition to PPD, our development strategy includes evaluating RE104 and other development candidates for the treatment of other depressive and mental health disorders.
PIPELINE
Promising New Science: Serotonergic Psychedelics
Direct agonism of the serotonin-2A (5HT-2A) receptor via serotonergic psychedelic therapy has shown immediate and durable clinical outcomes after a single dosage. We’re working to advance the initial discoveries of 5HT-2A compounds and develop new agents with safe, effective profiles.
RE104
RE104 is a patented, clinical-stage drug candidate designed as a short duration serotonergic psychedelic therapeutic to provide a fast-acting and durable antidepressive effect. RE104 aims to provide a safe and effective new therapeutic option for the large population of underserved patients suffering from postpartum depression and potentially other mental health indications.
RE104 rapidly converts to the clinically-active serotonergic form of the drug, 4-OH-DIPT (4-hydroxy-N,N-diisopropyltryptamine) after administration. Our Phase 1 clinical data indicate that RE104 produces a pharmacology similar to psilocybin with a reduced duration of the psychoactive experience.
We have completed our Phase 1 clinical trial and have identified a recommended Phase 2 dose where RE104 was shown to be safe and well tolerated, with no serious or severe adverse events. In addition, RE104 showed robust and pervasive pharmacodynamic effects with a short duration (3-4 hours) psychedelic experience. Plans are underway to start a Phase 2 clinical trial in PPD and in the future we may evaluate RE104 in terminally ill cancer patients who suffer from end-of-life distress, patients who suffer from treatment resistant depression (TRD) and/or other mental health indications.
Download the June 1, 2023 ASCP Phase 1 Poster Presentation (PDF)
RE200s
Our RE200 series of drug discovery candidates are structurally similar to classical psychedelics. They are designed to have selective potency at the target serotonin 2A receptor (5HT2A) and are devoid of off-target 5HT2B receptor agonism.
PUBLICATIONS
Barrett FS, Johnson MQ, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015;29(11):1182-1190. Read more
Gatch MB, Hoh A, Carbonaro TM. Discriminative stimulus effects of typtamines in rats. ACS Pharmacol Transl Sci. 2021;4(2):467-471. Read more
Haijen E, Kaelen M, Roseman L, et al. Predicting responses to psychedelics: A prospective study. Front Pharmacol. 2018;9:897. Read more
Hirschfeld T and Schmidt TT. Dose-response relationships of psilocybin-induced subjective experiences in humans. J Psychopharmacol. 2021;35(4):384-397. Read more
Klein AK, Chatha M, Laskowski J, et al. Investigation of the structure-activity relationships of psilocybin analogues. ACS Pharmacol Transl Sci. 2021;4(2):533-542. Read more
Waters K. Pharmacologic similarities and differences among hallucinogens. J Clin Pharamcol. 2021;61(S2):S100-S113. Read more
Yaden DB and Griffiths RR. The subjective effects of psychedelics are necessary for their enduring therapeutic effects. ACS Pharmacol Transl Sci. 2021;4(2):568-572. Read more