Toad You So: RTP’s Lusaris Plunks $60M Into Psychedelic Drugs to Fight Depression

Lusaris logo

A biotechnology startup – soon to be housed in Research Triangle Park – has launched with $60 million in funding and the aim of finding an effective therapy for treatment-resistant depression and other debilitating neuropsychiatric disorders.

Lusaris Therapeutics has announced plans to set up shop in RTP to work on its lead program – LSR-1019 – a proprietary, naturally derived and fast-acting serotonergic psychedelic compound. The company’s pipeline also includes two additional early stage drug candidates for migraine and cluster headache and other neuropsychiatric and neurological disorders.

Lusaris’ early funding comes from a Series A round of financing led by RA Capital Management, which also formed and incubated the business. RA Capital’s managing director, Andrew Levin, M.D., Ph.D., will serve as interim CEO while the new company looks for a permanent leader.

Neuropsychiatric and neurological disorders are among the world’s most prevalent and underserved health problems. And treatment-resistant depression (TRD) – defined as depression inadequately treated by two earlier lines of therapy – remains an unmet medical need. Psychedelic compounds are growing in popularity as potentially better behavioral therapies.

“Major depressive disorder is a severe, debilitating and inadequately treated disease resulting in millions of patients progressing to TRD,” Levine said. “Psychoplastogens have emerged as a promising treatment approach supported by compelling scientific evidence in patients with TRD and other severe neuropsychiatric conditions. We believe LSR-1019…has the potential to provide an important therapeutic advance for patients with severe depression who lack effective treatment options.”

Sonoran Desert Toad
Sonoran Desert Toad.

LSR-1019 is a sublingual (under-the-tongue) formulation of 5-Methoxy-N, N-dimethyltryptamine – or 5-MeO-DMT – a serotonergic psychedelic. It is found in the secretions of some plants and in the glands of the Sonoran Desert toad. Lusaris said clinical data suggest that 5-MeO-DMT has the potential to offer best-in-class effectiveness for people suffering with TRD.

If the psychedelic is administered orally, it becomes pharmacologically inactive because enzymes in the gut and liver metabolize it, the company said. So Lusaris has entered a strategic collaboration with Catalent for the exclusive worldwide license to Catalent’s Zydis fast-dissolving tablet technology for 5-MeO-DMT. The compound is designed to be placed under the tongue where it rapidly dissolves and is absorbed by the body. Catalent has a major presence in North Carolina.

Lusaris’s new drug’s psychedelic effect wears off quickly, but its benefit to the patient lasts much longer, Levin said. “A very high percentage of patients with a single administration can get dramatically better. How long that effect lasts, we don’t know for any individual."

The LRS-1019 program is in the preclinical stages. But Lusaris says it should move into a Phase 1 clinical study soon, with top-line data expected by mid-2023. Lusaris plans additional tests for other indications as well.

“We aim to develop best-in-class neurotherapeutics that have the potential to reach more patients in need by decreasing the treatment burden on both patients and physicians,” said Neil Buckley, Lusaris’ chief operating officer.

“With encouraging preclinical data, a proven delivery technology, and an expected rapid and short psychotropic experience, LSR-1019 has the potential to be a transformative treatment for patients suffering from TRD and other serious mood disorders.”

At launch, Lusaris said it had eight employees, about half of them in North Carolina and the others working virtually. The company says it expects to grow soon to 15 or 20.

Bryant Haskins, NCBiotech Writer
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