– Positive 7-day continuous delivery of CBD in rabbits equivalent to 35 mg/kg/day oral rabbit dose
– Positive skin irritation score
– Significantly lower AUC (drug exposure)
VANCOUVER, British Columbia, June 14, 2022 (GLOBE NEWSWIRE) — Pike Therapeutics Inc., a pre-clinical biotechnology company focusing on transforming synthetic cannabinoids and psychedelics with its proprietary continuous transdermal delivery, has completed a preliminary pharmacokinetic rabbit study with its CBD formulations that yielded positive early results. This study demonstrated that Pike’s continuous delivery technology delivered a sustained CBD blood level over 7 days equivalent to oral dosing and achieved an acceptable skin irritation score.
Pike’s goal is to leverage our proprietary delivery technology and these early findings to develop an approach that delivers the oral equivalent of 20 mg/kg/day and that could be equal or potentially superior in efficacy to the FDA approved CBD prescription product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet Syndrome (DS), or Tuberous Sclerosis Complex (TSC). In humans, this product has a dose to toxicity response which demonstrates that higher exposure is associated with higher toxicity and discontinuance. This would infer that lower AUC (exposure) would then lower toxicity and potentially improve tolerability. Pike’s objective is to use a dose that is significantly lower and achieve a target blood level that is efficacious. In Pike’s animal study we were successful in demonstrating a measurable lowering of exposure.
Potential benefits of Pike’s continuous delivery technology
- The FDA-approved CBD seizure product side effect profile is dose-related, and dose escalation stops when patients can no longer tolerate it or due to toxicity. Dose escalation monitors drug tolerability and toxicity, starting with 5 mg/kg/day and moving to a target 20 mg/kg/day. Pike’s early findings offer the possibility to skip dose-escalation administration and move directly to the target maintenance dose.
- Pike will be delivering a measurable amount of less drug continuously, which may offer an opportunity to push the target dose higher offering an increased therapeutic effect.
Brad Miles, CEO, said, “We feel that the data from this animal study is significantly pertinent to our current stage of development and provides Pike with a strong base to move our platform forward.”
Pike intends to proceed with full development of our transdermal patch in multiple indications. Our next steps include finalizing the transdermal patch development so that we can enter the clinical stage.
About Pike Therapeutics
Pike is a pre-clinical stage biotechnology company that is focused on transforming synthetic cannabinoids and psychedelics using our proprietary transdermal technology platform that uses significantly lower drug exposure combined with continuous delivery to target increased efficacy and tolerability.
To learn more, visit www.piketx.com
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