- DeFloria, a joint venture between Charlotte’s Web (TSX:CWEB), Ajna BioSciences and British American Tobacco, yielded positive results from a phase-1 dose trial of AJA001, its cannabis-based drug candidate to treat symptoms of autism spectrum disorder
- Results show that AJA001 was well-tolerated with a favorable pharmacokinetic profile
- Charlotte’s Web specializes in wellness products made from hemp extracts including CBD and CBN
- Charlotte’s Web stock has given back 46.43 per cent year-over-year and 98.69 per cent since 2019
DeFloria, a joint venture between Charlotte’s Web (TSX:CWEB), Ajna BioSciences and British American Tobacco, yielded positive results from a phase-1 dose trial of AJA001, its cannabis-based drug candidate to treat symptoms of autism spectrum disorder (ASD).
The phase-1 randomized, double-blind, placebo-controlled trial evaluated the tolerability and pharmacokinetic (PK) / pharmacodynamic (PD) profile of several dose levels in 70 healthy volunteers between 19 to 55 years old.
Results show that AJA001 was well-tolerated up to 680 mg per day as a single dose and up to 660 mg per day administered twice daily.
In all cases, the drug candidate displayed dose-proportional PK for CBD and THC “that matched or exceeded the plasma concentrations of the comparable cannabinoid therapeutics dronabinol, nabiximols and Epidiolex,” according to Thursday’s news release. PK data after multiple doses showed minimal accumulation of CBD or THC after 7 days.
AJA001’s PD profile is dose-dependent and correlated with peak plasma concentrations of THC and its active metabolite, 11-OH-THC, following single doses.
Responses from the trial’s drug effects questionnaire characterize AJA001’s effects as moderate and transient, granting it dosing flexibility.
Adverse events during the trial included somnolence, anxiety, dizziness and headache. A participant receiving 906.4 mg of AJA001 experienced anxiety qualifying as a serious adverse event, which was resolved the following day with no sequalae.
DeFloria believes phase-1 results support doses from 100 mg to 660 mg of AJA001 per day for phase-2 trials in children, adolescents and adults with ASD.
Leadership insights
“We are extremely encouraged by these results from our phase-1 single and multiple ascending dose trial, which demonstrate that AJA001 is well-tolerated across a range of doses and provides a favorable pharmacokinetic profile for both cannabidiol and tetrahydrocannabinol,” Marcel O. Bonn-Miller, chief scientific officer at Charlotte’s Web and board member at DeFloria, said in a statement. “Importantly, the results from this trial inform the doses to be evaluated in upcoming phase-2 clinical trials of AJA001 in children, adolescents and adults with ASD.”
“We are excited to present this important data and look forward to initiating two phase-2 trials of AJA001 in ASD in the second quarter of 2025,” added Jared Stanley, DeFloria’s chief executive officer. “Despite its prevalence, ASD remains a difficult condition to treat. Moreover, currently available treatments for ASD are not well tolerated, making patient compliance a challenge. DeFloria is committed to supporting the ASD community and developing AJA001 to treat the behavioral symptoms associated with ASD with a drug product that is designed to provide broad therapeutic efficacy.”
About Charlotte’s Web Holdings
Charlotte’s Web specializes in wellness products made from hemp extracts including CBD and CBN. The company is the official CBD provider of Major League Baseball and the Premier Lacrosse League.
Charlotte’s Web stock (TSX:CWEB) is unchanged trading at C$0.15 per share as of 9:48 am ET. The stock has given back 46.43 per cent year-over-year and 98.69 per cent since 2019.
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(Top photo: Charlotte’s Web Holdings)
