Biotechnology and pharmaceutical companies have a long history of mining the world’s flora and fauna for substances they can turn into drugs.
The latest to do so, a startup called Lusaris Therapeutics that emerged Wednesday, aims to develop a compound found in the glands of the Sonoran Desert toad into a fast-acting psychedelic that can treat depression and other psychiatric conditions.
Backed by RA Capital and several other investors, Lusaris launches with $60 million in funding and plans to move quickly into clinical testing with an under-the-tongue formulation of the compound, called 5-MeO-DMT. Also found in plants, 5-MeO-DMT is well known as a psychoactive substance and has been used as a holistic treatment.
Another biotech company, called GH Research and backed by RA Capital as well, has been developing an inhaled version of 5-MeO-DMT. It has completed two Phase 1 studies in healthy volunteers, as a well as a small Phase 1/2 study in people with treatment-resistant depression that suggested a potent antidepressant effect.
The team behind Lusaris was excited by that finding, said interim CEO Andrew Levin, but thought it could be better delivered with a simpler method of administration. In GH’s study, dosing of the inhaled 5-MeO-DMT formulation was individualized, and titrated for up to three doses over the course of a day.
“The problem we're solving for, relative to other 5-MeO-DMT companies, is a single administration of a single tablet under the tongue, and ultimately the potential for a more consistent treatment effect with that one administration,” said Neil Buckley, chief operating officer at Lusaris.
Lusaris has partnered with Catalent and secured license to the contract company’s “Zydis” fast-dissolving tablet technology to develop its 5-MeO-DMT treatment. According to Buckley, the Zydis tablet will be Lusaris’ primary formulation, although he said the company will do some bridging research beforehand.
The company plans to start a Phase 1 study “imminently” and has plans for multiple Phase 2 trials, including a randomized controlled test in treatment-resistant depression. The $60 million will fund that work and the company’s broader operations “well into 2025,” Levin said.
Levin, who is also a partner and managing director at RA Capital, will lead the company for the time being, although Lusaris will look to fill the CEO role permanently next year.
In addition to its lead 5-MeO-DMT program in treatment-resistant depression, Lusaris is also planning to develop drugs for other neurological conditions, including migraine and cluster headache.
Joining RA in funding the company are Venrock Healthcare Capital Partners, Deep Track Capital, Boxer Capital and one other undisclosed investor.