Pike Therapeutics Inc said it has completed a preliminary pharmacokinetic rabbit study with its CBD formulations that yielded positive early results.
The company said the 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 US Food & Drug Administration (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. The company said 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 the animal study Pike was successful in demonstrating a measurable lowering of exposure.
Potential benefits of continuous delivery technology
The company said 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 noted that its early findings offer the possibility to skip dose-escalation administration and move directly to the target maintenance dose.
The company said it 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.
In a statement, Brad Miles, the company's 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."
The company said it intends to proceed with full development of the transdermal patch in multiple indications. Its next steps include finalizing the transdermal patch development so that it can enter the clinical stage.
Pike Therapeutics is a pre-clinical stage biotechnology company that is focused on transforming synthetic cannabinoids and psychedelics using its proprietary transdermal technology platform that uses significantly lower drug exposure combined with continuous delivery to target increased efficacy and tolerability.
Contact the author at jon.hopkins@proactiveinvestors.com