The psychedelic developed by Reunion Neuroscience has been shown to mitigate the effects of postpartum depression in a phase 2 trial, and now the biotech is preparing to conduct a late-stage trial in 2023.
The medication under consideration is RE104, a pseudo drug of 4-OH-DiPT, the effect of which is intended to achieve a similar effect to that of the magic mushroom extract psilocybin within a shorter period. Reunion was acquired by MPM BioImpact in 2023 and has been assessing RE104 in 84 adult female participants with moderate to severe postpartum depression (PPD). At least 50 percent improvement in a depression score on Day 7 occurred in 77.1 percent of patients on an active control candidate and a 30-mg subcutaneous dose of RE 104, compared to 61.6 percent of patients on an active control arm taking 1.5 mg of RE 104, as noted in the Reunion note.
The 30-mg cohort revealed an average decrease of 23 points on the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to the baseline, to 17.2 in the control arm. By comparison, when it came to patients who achieved a reduction in MADRS score to 10 or lower, defined as entering remission, 71.4 percent of patients on the RE104 arm had reached this indicator by Day 7, compared to 41 percent of the control cohort.
The biotech observed that the response and remission rates remained even after a follow-up at Day 28 for patients.
Secondary endpoints, including a self-reporting measure of overall maternal functioning, also supported the primary endpoint win, Reunion added.
Concerning safety and tolerability, nausea was reported in nearly 44 percent of patients, and a headache in 34 percent. But, Reunion noted: these events were generally mild to moderate in severity, predominantly on the day of treatment and experienced spontaneous resolution, and are consistent with those reported with other agents in the class.
Ninety-two-point seven percent of the patients were also ready to go home within four hours of their treatment, as the company explained. A lactation study in the meantime, already had some preliminary data that indicated that mothers could go back to breastfeeding their children faster, and Reunion added that that was again, rapidly.
The results of our Reconnect phase 2 trial are encouraging, and this provides excellent clinical confirmation of the potential of RE104 as a low-side-effect, fast-acting, and effective treatment option that provides patients with rapid PPD relief, with little interference to daily routines,” said Mark Pollack, Chief Medical Officer of Reunion in the press release.
Pollack added, these data on RE104 confirm our proposed path to pivotal trials with the start of a phase 3 trial projected in 2026.
The company also expects to initiate a phase 2 trial of RE104 in a few weeks that would be used to treat adjustment disorder (AjD)-how individuals feel about and react to the stressful event-in cancer and other disease patients. It is penciled in the first quarter of 2026 as another phase 2 in an unspecified significant mental health indication.
Pollack commented, we highly believe that RE104 can provide a step change in the standard of care in debilitating conditions like PPD and AjD, and we are excited by the prospect of putting it to further use in the treatment of a variety of underserved mental health-related disorders.
Reunion has been able to finance its RE104 strategy through a series A funding of 103 million in May 2024. The executives cited at the time an average effect duration of the drug, which is less than four hours during a phase 1 study, compared to a six to eight-hour average of Compass Pathways’ psilocybin study. This saved on administration time, and this was one of the main features of Reunion because Reunion was able to attract large-name investors such as Novo Holdings to fund Series A.
Executives also asserted then that the psychedelic industry had enjoyed the precedent of the intranasal S-ketamine therapy Spravato made by Johnson & Johnson, which is approved as an adjunctive treatment of patients with treatment-resistant depression. Medical workers are requested to supervise patients for not less than two hours following the Spravato intake.
One recent development worth noting in the psilocybin space is Compass. In June, it received phase 3 approval in treatment-resistant depression of its synthetic version of the magic mushroom extract called COMP360. But the figures seem to disappoint investors.
