Skye Bioscience Completes THCVHS IND-enabling In Vitro Genotoxicity Studies
August 10th, 2021
THCVHS shows no signs of chromosomal or gene mutations in preclinical studies
SAN DIEGO, CA, Aug. 10, 2021 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye”), a biopharmaceutical company developing proprietary, synthetic cannabinoid-derived molecules to treat diseases with significant unmet need, has successfully completed genotoxicity studies of THCVHS required prior to beginning its planned Phase 1 clinical study in Australia. Skye is initially developing THCVHS as a treatment of glaucoma.
Genotoxicity safety studies are required by both the Australian Therapeutic Goods Administration and the U.S. Food & Drug Administration prior to initiating human trials and were completed at BioReliance Corporation under Good Laboratory Practices regulations, which meet the standards for both agencies. BioReliance is the world’s leading provider of safety testing services and includes among its customers many of the largest pharmaceutical, biopharmaceutical, and chemical companies around the globe.
“Genotoxicity data are a prerequisite to enter into human trials in all major markets. Although the safety profile for the active pharmaceutical ingredient, THC, is well-recognized, this was the first time these studies were performed with our proprietary molecule THCVHS, a prodrug of THC,” said Punit Dhillon, CEO of Skye Bioscience. “We are pleased to have successfully completed these studies and continue to advance our nonclinical requirements prior to initiating our first-in-human trial, as well as future clinical trials in the US.”
Two studies were carried out to assess the genotoxicity potential of THCVHS. The first was a mammalian cell micronucleus assay, which is designed to determine a compound’s ability to generate chromosomal aberrations and considered to be one of the most reliable assays in determining genotoxicity. The second study was a reverse bacterial mutagenesis assay, also referred to as the Ames test, which assesses the ability of a compound to generate gene mutations. Both assays produced negative results indicating that THCVHS is not a genotoxic compound, clearing a key step to allow for human trials.
THCVHS, a proprietary prodrug of tetrahydrocannabinol (THC), is a topical formulation under development to treat glaucoma. Through the application of rational drug design, Skye has chemically modified THC to create a unique synthetic molecule with the intent to safely realize the known positive effects of THC. THCVHS enables enhanced local delivery of the drug into the eye, provides significant lowering of intraocular pressure, minimal systemic exposure, and potential for neuroprotection.
About Skye Bioscience
Skye Bioscience Inc. is a biopharmaceutical company unlocking the pharmaceutical potential of cannabinoids through the development of its proprietary, cannabinoid-derived molecules to treat diseases with significant unmet needs. The company’s lead program, THCVHS, is focused on treating glaucoma, a disease with no cure and the world’s leading cause of irreversible blindness. For more information, please visit: www.skyebioscience.com.
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