Sublingual psychedelic startup nets $60M for depression trials

Investors are betting sublingual drug delivery can unlock the potential of a psychedelic, pumping $60 million into Lusaris Therapeutics to support clinical trials of a depression candidate.

The psychedelic molecule, 5-methoxy-N,N-dimethyltryptamine, is pharmacologically inactive when given orally because it is rapidly metabolized by enzymes in the gut and liver. To get around the limitation of the candidate, Lusaris has secured an exclusive worldwide license to use Catalent’s Zydis fast-dissolving tablet technology with the molecule.

Lusaris expects the technology to result in a formulation that dissolves under the tongue within seconds and is absorbed without the need for water. By opting for a sublingual approach, the biotech believes it is eliminating the need for burdensome drug delivery systems, simplifying administration and offering “the potential for more consistent exposure and more predictable therapeutic benefit in patients.”

RA Capital Management has stepped up to help Lusaris learn whether the theory holds up in the clinic. Having incubated the biotech, RA Capital led the series A round with assists from Venrock Healthcare Capital Partners, Deep Track Capital, Boxer Capital and an additional undisclosed investor.

The syndicate’s support will enable Lusaris to start phase 1 clinical trials of the candidate, LSR-1019, imminently with a view to delivering top-line data around the middle of next year. The biotech will study its candidate in treatment-resistant depression (TRD) and other severe neuropsychiatric disorders. Earlier work suggests 5-MeO-DMT is a psychoplastogen that promotes structural and functional neural plasticity.

“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, our proprietary sublingual formulation of 5-MeO-DMT, has the potential to provide an important therapeutic advance for patients with severe depression who lack effective treatment options,” Andrew Levin, M.D., Ph.D., interim CEO of Lusaris and partner and managing director at RA Capital, said in a statement.