Our Approach

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 are evaluating RE104 as a potential treatment for women suffering from 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 viable regulatory approved therapy indicated for PPD has side effects that include sedation (with Black Box warning) and potential addiction and embryo-fetal toxicity. 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 solution that offers a faster onset of action, greater efficacy after only a single dose, with limited interruption in breast feeding and a faster return to normal daily activities.

Psychiatric Distress in Cancer

We are also planning to evaluate RE104 as a potential therapy solution for psychiatric distress in cancer (PDC). It is estimated that 23.4% of cancer patients suffer from depression and 19.1-19.9% suffer from anxiety. PDC is one of the initial indications studied by researchers on psychedelic treatment and several clinical trials indicate the potential for rapid and meaningful improvements in depression and anxiety with durable changes in attitude and behavior.

Cancer patients under psychological distress have reduced compliance with treatment and prolonged hospitalizations. Psychosocial distress interferes with the ability to cope effectively with cancer, its physical symptoms and treatment. This in turn can contribute to poor outcomes in patients.

We believe there is a significant unmet need for a rapid acting solution for these cancer patients to positively impact cancer treatment compliance, hospitalization time and improved quality of life.

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.