Enveric Biosciences reports no phototoxicity risk for EB-003 candidate
Enveric Biosciences (NASDAQ: ENVB) announced that preclinical testing showed no photoreactive potential for its lead neuroplastogen candidate EB-003, according to a company statement.
The phototoxicity analysis evaluated whether EB-003 could become harmful when exposed to UV light. The testing is required by regulatory agencies including the FDA under ICH S10 guidelines for pharmaceutical compounds in development.
EB-003 is designed to engage both 5-HT2A and 5-HT1B receptors and is being developed for treatment of neuropsychiatric disorders including depression, anxiety and post-traumatic stress disorder. The compound is intended for chronic treatment of these conditions.
"The demonstration of limited potential for phototoxicity enhances the favorable safety profile of EB-003," said Joseph Tucker, CEO of Enveric Biosciences. "We continue to de-risk EB-003 as we look forward to initiating first-in-human Phase 1 clinical trials."
Some photoactive chemicals can cause reactions similar to severe sunburn, rashes or blistering in sun-exposed tissues such as eyes and skin, which can limit pharmaceutical product utility.
The Cambridge, Massachusetts-based biotechnology company focuses on developing small-molecule neuroplastogenic therapeutics for psychiatric and neurological disorders. The company states that EB-003 represents the first known compound designed to selectively target both receptor types mentioned.
Enveric plans to submit an investigational new drug application to initiate Phase 1 clinical trials for EB-003.
