Dr. Karolina Urban reports

AVICANNA ANNOUNCES SPONSORSHIP OF UNIVERSITY OF CALGARY THC DOSE FINDING CLINICAL TRIAL

Avicanna Inc. has initiated new phase I randomized, double-blinded, placebo-controlled, dose-finding clinical trial led by researchers at the University of Calgary's Cumming School of Medicine.

Study overview

The trial is led by Dr. Leah Mayo, assistant professor, and supported by Dr. Matthew Hill, professor at the University of Calgary. This single site, randomized, double-blind, placebo-controlled crossover trial will enroll 24 healthy adult participants. Participants will receive single oral doses of THC across separate study visits at six milligrams, nine mg and 15 mg, as well as placebo, with washout periods between dosing sessions. Primary end points focus on validated psychometric assessments of anxiety and subjective response. Secondary end points include measures of mood and intoxication, cardiovascular parameters, circulating stress biomarkers, endocannabinoid system markers and pharmacokinetic profiling. The trial is designed to generate high-resolution dose response data to better define the therapeutic window of oral THC and to characterize interindividual variability in response.

Investigational product

The trial utilizes Avicanna's proprietary AVCN319301b THC capsules which utilize the company's solid self-emulsifying drug delivery system (SEDDs) technology. Due to the highly lipophilic nature and poor water-solubility of cannabinoids, typical cannabis formulations have poor absorption and variability of onset. Avicanna's oral delivery systems offer an effective route for non-invasive and non-inhalation administration of cannabinoids. The proprietary capsules are also enrolled in a previously announced pilot phase II randomized controlled trial (RCT) for osteoarthritis with the University Health Network. Avicanna's SEDDs technology has demonstrated robustness and versatility through different drug delivery formats including several commercial products such as liquid infuser drops, capsules and an extensive pipeline of products currently in commercialization stage.

"We are pleased to be expanding our clinical collaborations with the University of Calgary and to be working alongside Dr. Hill and Dr. Mayo, who are internationally recognized for their contribution to cannabinoid science and anxiety research. This trial represents our second randomized controlled trial that is evaluating our proprietary capsule and marks another important step in advancing our pharmaceutical development pipeline through rigorous, investigator-led research," stated Dr. Karolina Urban, executive vice-president of medical and scientific affairs at Avicanna.

About Avicanna Inc.

Avicanna is a commercial-stage international biopharmaceutical company focused on the advancement and commercialization of cannabinoid-based products and formulations for the global medical and pharmaceutical market segments. Avicanna has an established scientific platform including R&D (research and development) and clinical development leading to the commercialization of more than thirty proprietary, evidence-based finished products and supporting four commercial stage business pillars.

• Medical Cannabis formulary (RHO Phyto): The formulary offers a diverse range of proprietary products including oral, sublingual, topical and transdermal deliveries with varying ratios of cannabinoids, supported by continuing patient and medical community education. RHO Phyto is an established brand in Canada currently available nationwide across several channels and expanding into new international markets.
• Medical cannabis care platform (MyMedi.ca): MyMedi.ca is a medical cannabis care platform formed with the aim to better serve medical cannabis patients' needs and enhance the medical cannabis patients' journey. MyMedi.ca is operated by Northern Green Canada Inc. and features a diverse portfolio of products and bilingual pharmacist-led patient support programs. MyMedi.ca also provides specialty services to distinct patient groups such as veterans and collaborates with public and private payers for adjudication and reimbursement. MyMedi.ca provides educational resources to the medical community to facilitate the incorporation of medical cannabis into health care regimens.
• Pharmaceutical pipeline: Leveraging Avicanna's scientific platform, vertical integration and real-world evidence, Avicanna has developed a pipeline of proprietary, indication-specific cannabinoid-based candidates that are in various stages of clinical development. These cannabinoid-based candidates aim to address unmet needs in the areas of dermatology, chronic pain and various neurological disorders.
• Active pharmaceutical ingredients (Aureus Santa Marta): Active pharmaceutical ingredients supplied by the company's majority owned subsidiary, Santa Marta Golden Hemp SAS (SMGH), is a commercial-stage business dedicated to providing various forms of high-quality CBD, THC and CBG to the company's international partners for use in the development and production of food, cosmetics, medical and pharmaceutical products. SMGH also forms part of the company's supply chain, and is a source of reliable input products for its consumer retail, medical cannabis and pharmaceutical products globally.

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