Pills are generally superior to injections and infusions when it comes to drug formulations. They are more convenient for the patient because administration does not require a visit to a clinical site. But in depression, a pill version of the psychedelic compound psilocybin may not work optimally. In a push for more oral depression medications, Eleusis is developing a psilocybin-infused formulation it says could overcome the limitations of oral psilocybin.As the biotech prepares to conduct the first human test of its drug, it has signed a Merger transaction That injected $288 million into it.
Eleusis, which maintains operations in London and New York, announced Thursday that it had reached an agreement with publicly traded Silver Spike Acquisition Corp. II, a special purpose acquisition company or SPAC. The boards of directors of both companies have approved the transaction, which is expected to close in the second or third quarter of this year.
Psilocybin is a psychoactive chemical found in certain mushrooms.industry and Academic Research Studies have shown that drugs containing psilocybin as the active ingredient can have an effect on depression.However, Eleusis said in an article Investor introduction These studies also showed differences in the way drugs are absorbed and metabolized by the body — even when given to patients in the same dose. This variability may require higher doses, which in turn can lead to unpredictability in how the drug is absorbed and processed. In addition, these drugs require prolonged treatment, and patients taking these drugs must be observed for up to six hours. Eleusis believes that these properties of oral psilocybin prevent the drug from being widely available, even if the drug is approved by the FDA.
Eleusis’ lead drug candidate, ELE-Psilo, is formulated to deliver the active ingredient in psilocybin by intravenous infusion. As an infusion, the drug offers the potential for more consistent treatment effects and shorter treatment times, the company said in the presentation. The infusion takes 10 to 30 minutes, followed by monitoring in the clinic for two hours or less. In addition, Eleusis says its formulation can be tailored to the patient by adjusting the intensity of the treatment by changing the infusion rate.
Although infusions are not as convenient as pills that can be taken anytime, anywhere, Eleusis aims to make infusions more accessible through Andala, a subsidiary of the company that operates drug treatment clinics. The clinics already administer doses of mental health medications, including J&J’s depression drug Spravato. that medicine, Approved in 2019 as a nasal spray for ketamine, a compound that can produce dissociation.
If ELE-Psilo enters the market, Andara Clinic will provide patients with access to treatment. Eleusis said it expects to sell all or part of its stake in Andala before the FDA approves ELE-Psilo or any of the biotech’s other drug candidates.
In an investor presentation, Eleusis said it plans to begin evaluating a Phase 1 study of ELE-Psilo in the second quarter of this year. The study will test the drug first in healthy volunteers and then in patients with major depressive disorder. The results of the study are expected in the second half of this year.
Eleusis was founded in 2013. The biotech’s CEO and founder, Shlomi Raz, said in a company video that the company’s intellectual property is part of a broader drug discovery effort that has been underway since 2017. David Weiner, vice president of pharmaceuticals at Eleusis, found, said in the video, that the main receptors for psychedelics are found throughout the body, offering the potential to expand psychedelics beyond psychiatry. The company’s research has resulted in a topical drug candidate, ELE-102, for preclinical development in eye diseases. Potential applications for the drug include glaucoma, tear secretion, allergic conjunctivitis and uveitis, an inflammation of the eye, Weiner said.
The combination of Eleusis and Silver Spike will allow the biotech to receive up to $287.5 million from the SPAC’s account to fund its drug development programs. Eleusis shares held by its existing shareholders will become equity interests in the combined company, with a one-year lock-up period. After the transaction closes, these Eleusis shareholders will own approximately 49% of the combined company. Silver Spike’s shareholders and sponsors of the SPAC will own 51% of the combined company as long as those shareholders do not sell their shares.
Eleusis isn’t the only biotech company trying to develop better psychedelic drugs.Headquartered in Boston last September Delix Therapeutics announces $70 million in Series A financing to support development of oral psychedelics that do not cause hallucinations and other side effects. The company said it expects to begin clinical trials in 2022. London-based Compass Pathways is developing an oral psilocybin drug for depression. In November, the company report The results of an interim study aimed at finding the right dose to enter Phase 3 testing.
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