CAMBRIDGE, Mass. — Enveric Biosciences reported new preclinical data that it said further supports the non-hallucinogenic profile of EB-003, its lead drug candidate for psychiatric and neurological disorders.
The biotechnology company said EB-003 was evaluated using the GloSensor cAMP assay, a sensitive live-cell test designed to detect receptor signaling responses in real time.
Researchers compared EB-003 with known hallucinogenic and non-hallucinogenic compounds. According to Enveric, EB-003 consistently produced results within the range associated with non-hallucinogenic compounds.
The findings were consistent with previously reported data from a separate bioluminescence resonance energy transfer, or BRET, assay, the company said.
Enveric also said the results aligned with research published in Nature that identified signaling characteristics that may distinguish hallucinogenic compounds from those expected to be non-hallucinogenic in humans.
That research linked activation of a specific signaling pathway through the serotonin 5-HT2A receptor with hallucinogenic effects. Enveric said EB-003 did not demonstrate the level of signaling associated with hallucinogenic compounds in its testing.
“These new findings further support our previous studies regarding the differentiated design of EB-003 and its non-hallucinogenic profile,” CEO Joseph Tucker, Ph.D., said.
“The consistency of the data across multiple independent assay platforms provides important validation of our approach as we prepare to advance EB-003 into Phase 1 clinical development,” Tucker added.
Enveric is developing EB-003 as a neuroplastogenic therapy intended to promote changes in brain connectivity without producing a hallucinogenic experience. The company plans to advance the drug into a first-in-human Phase 1 clinical trial.
The company said a non-hallucinogenic treatment could potentially avoid some of the clinical and operational challenges associated with psychedelic therapies, including intensive patient monitoring, psychotherapy requirements and difficulties maintaining blinded clinical trials.
The U.S. Food and Drug Administration has issued guidance addressing the clinical and regulatory considerations involved in developing hallucinogenic psychedelic drugs.
Enveric said that if EB-003’s non-hallucinogenic profile is confirmed in human studies, the candidate could potentially be administered through a more conventional outpatient treatment model and be easier to evaluate in blinded clinical trials.
