XPhyto Therapeutics Corp. (CSE:XPHY, OTCQB:XPHYF) has provided an update on the development of its fast-dissolving CBD oral strips, noting that its European human CBD bioavailability study will start in January 2022.
In a statement, Professor Thomas Beckert, managing director of XPhyto’s German narcotics manufacturing company Vektor Pharma TF GmbH, said: "The clinical trial of our CBD product is aiming to demonstrate the efficient and precise dosing of the treatment.”
“If successful, this could make a significant difference to epilepsy patients, and we are excited to commence the trial next year," added Dr. Beckert, who spearheads the management of XPhyto's drug formulation and diagnostics business.
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XPhyto said it is developing a hybrid-generic CBD prescription drug formulation that employs the company's proprietary oral dissolvable (ODF) platform to deliver precise and efficient CBD dosages for the treatment of certain forms of childhood epilepsy.
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved CBD-based medical products from other companies for the treatment of severe childhood forms of epilepsy, including Dravet syndrome and Lennox-Gastaut syndrome.
The currently approved and registered formulation of CBD is a lipophilic solution in sesame oil with a standard dosage of 750 mg a day. “Due to low bioavailability (approximately 5%) the formulation could be considered highly inefficient compared to the XPhyto ODF platform,” said the company.
XPhyto noted that for carrying out its clinical study, a slew of important activities have been completed and resulted in the firm having a product development report, investigational medicinal product dossier, a permit for clinical study, manufacture of clinical product samples, and a product specification file. The firm has also rounded out a monitoring agreement and an import authorization to the location of the FDA-inspected clinical research center.
Pending success in the CBD pilot study, the company expects to carry out a pivotal clinical study in the second half of 2022, said XPhyto.
The company's CBD-based epilepsy treatment program is one of several dissolvable oral drug delivery programs. Oral thin film drug delivery is a large and growing international industry that provides an alternative to conventional solid and liquid oral dosage forms.
The global market for thin-film drug manufacturing will be worth US$15.98 billion by 2024, rising at a 9.0% compound annual growth rate (CAGR) between 2019 and 2024, according to Transparency Market Research. XPhyto's additional oral thin film drug delivery programs include both cannabinoid and non-cannabinoid products for pain, neurology, and infectious disease. The cannabidiol market revenue is estimated to be worth over US$89 billion by 2026, according to Global Market Insights Inc.
XPhyto is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities. It has research and development operations in North America and Europe, with an operational focus in Germany.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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