Psychedelics therapies – serotonin 2 A receptor agonists – are trying to enter mainstream medicine for depression and as anti-inflammatory or neuroprotective treatments.
A scientist peers into a microscope in an Eleusis lab/courtesy Eleusis
Psychedelics therapies – serotonin 2 A receptor agonists – trying to enter mainstream medicine for depression and as anti-inflammatory or neuroprotective treatments.
At Eleusis, “We’re focused on how to make investigational psychedelic therapies compatible with the current healthcare system,” Shlomi Raz, CEO, told BioSpace. “We’re in the midst of an epidemic, and depression is public enemy No. 1. There is a constellation of unmet needs in mental health. Transforming promising psychedelic therapies, like psilocin – the active ingredient in psilocybin – into viable FDA-approved treatment options could revolutionize how depression is treated. Psilocin may have the potential to enable patients to have less severe symptoms while avoiding the side effects of traditional antidepressants.”
Making psilocybin-based therapeutics compatible with the current healthcare system requires two things: drug development and a bespoke care delivery system, he said. Eleusis is active on both fronts.
On the drug development side, Eleusis plans to initiate Phase I trials of ELE-Psilo in the U.K. in the first half of 2022, with delivery via infusion. Treatment is anticipated to take about two hours from start to finish, including post-administration monitoring to ensure the patient has recovered sufficiently from any perceptible effects of the drug.
“We do expect ELE-Psilo to induce a perceptible effect during infusion,” Raz explained. “We expect that, within about two minutes of starting the infusion, the participant will perceive hallmark perceptual and cognitive effects commonly associated with psychedelics. Our hypothesis is that the intensity of these effects could be correlated with any observed antidepressant effect, but it isn’t yet known whether the perceptible effects of the treatment contribute to the potential for antidepressant effects, or whether they are incidental biomarkers of the therapeutic effects observed in third party studies.” He added that the perceptual effects are anticipated to persist for about 20 to 40 minutes after the infusion, based on results from prior third-party academic research.
“Preclinical studies and limited human clinical trials suggest the previously-observed therapeutic effects could last at least a week, if not months. In animal models, the therapeutic effects of one infusion of psilocybin lasted up to 45 days,” Raz said. A comparable dose of ketamine, in contrast, lasts only a few days in the same animal model of depression.
The other potential benefit of investigational psychedelic therapies like ELE-Psilo is that the therapeutic benefits may become evident more quickly than the three weeks typical of commonly prescribed antidepressants – selective serotonin reuptake inhibitors (SSRIs). Therefore, “We intend to initially explore a rapid-acting antidepressant label. In the future, we will evaluate the potential of ELE-Psilo as a monotherapy.”
In the U.K., the company has been granted an Innovation Passport Designation for ELE-Psilo for the treatment of adult treatment-resistant depression. Similar to the U.S. Food and Drug Administration‘s Fast-Track designation in the United States, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) Innovation Passport provides the company access to specialist advice throughout the drug development process with the potential of enabling an accelerated and more efficient development process.
“We’re also addressing the last-mile delivery challenges,” he said. That includes developing a sister company, Andala, which will focus on managing clinics to facilitate patient access to currently-available psychoactive drugs for interventional psychiatric drug therapy covered and reimbursed by third-party payors.”
“Investigational drugs like ELE-Psilo aren’t something a patient would take at home,” Kathy Kaluhiokalani, president of Andala, told BioSpace. The FDA likely will require a risk evaluation and mitigation strategy (REMS) that will include patient monitoring during therapy, an assessment of when patients can leave the clinic and a strategy to ensure the drug is stored safely before administration. “We believe a dedicated point-of-care delivery infrastructure could make ELE-Psilo, if approved by the FDA, accessible by addressing the pinch points, including reimbursement.”
Andala seeks to establish a network of managed clinics that are focused on providing access to care that would be eligible for insurance reimbursement. The aim is to make FDA-approved therapies like SPRAVATO (esketamine) accessible and affordable today and enable access to any future FDA-approved psychedelic drug therapies.
“Andala is working with large insurance providers in Texas so insured patients can access FDA-approved therapies like SPRAVATO,” Kaluhiokalani continued. She was part of the leadership team that built MedExpress from a 60-site urgent care provider to one of the largest urgent care networks in the U.S. If Andala succeeds in Texas, a larger rollout is expected.
A dedicated network of managed clinics may be necessary to overcome the practical barriers to access, Raz pointed out. “I’m struck by how many (depression) patients never see a psychiatrist. They’re treated by primary care physicians,” but most small- and medium-sized psychiatric group practices lack the staff and resources to deliver SPRAVATO on-premises. “I believe having a dedicated place where patients can receive interventional therapy will have a huge role in the future of mental health therapy,” he said. “Eventually, we plan to spin-out Andala as a separate company.”
Eleusis, founded in 2013, also has announced plans to go public via a NASDAQ special purpose acquisition corporation (SPAC) with Silver Spike Acquisition Corp. II. As Raz said, “We have an exciting pipeline and have assembled a top team of experienced leaders in drug development and healthcare.” For Example, Rob Conley, SVP for clinical development, recently retired from Eli Lilly, where he was CSO for late-phase neuroscience. David Weiner, M.D., V.P. of drug discovery, joined Eleusis after a career that included serving as CMO at Lumos Pharma, interim CEO at Proteostasis Therapeutics, and heading EMD Serono’s global early clinical development programs in neurology.
Milestones for this year include plans to initiate a Phase I trial for ELE-Psilo with a safety readout and a Phase IIa study in depressed patients to compare results with those reported previously in peer-reviewed studies. In 2023, he added, “We aim to see a positive cash flow from Andala, which will show this approach is self-sustaining and so can be expanded nationally. As we prove we can deliver on milestones…we can begin to execute on the next aspects.”
Those aspects may include a new investigational drug the company is developing to be delivered as a topical eye drop – without anticipated perceptual effects – to address ocular inflammation, he suggested. “Psychedelics could have profound potential in mental health and in other applications that don’t give rise to perceptible effects.
“We have an opportunity to do good and to do well,” Raz said. “ELE-Psilo has exciting potential as a treatment for depression and a realistic egalitarian endgame.”
