XPhyto Reports Development Update for its Drug Delivery Business
- Rotigotine transdermal skin patch optimization and pivotal study planning underway
- Rotigotine patch manufacturing, sales and marketing in preparation
- Cannabinoid oral dissolvable film (ODF) programs advanced, CBD ODF ready for pilot study
- Prioritization of additional near-term drug formulation programs underway
"XPhyto's strategy is to advance its thin-film technology platform to develop innovative formulations of generic and hybrid-generic drugs. In 2021, we have completed the pilot study for our lead program and are expecting to complete pilot studies for our three cannabinoid drug formulation programs in Q4 2021 and Q1 2022," said
Based on its human bioavailability pilot study completed in
Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome in
According to
XPhyto is currently advancing three hybrid-generic oral dissolvable ("ODF") cannabinoid products: CBD, THC, and 1:1 CBD:THC. The chemical similarities between the three related ODF formulas have led to research and development efficiencies as knowledge gained in each program has been utilized in the others, including patentable technological advancements in the Company's ODF platform. Due to the harmonization of regulations between certain jurisdictions within the EU and changing documentation requirements, XPhyto's contract research organization ("CRO") is awaiting approval for the import of clinical materials to carry out human bioavailability pilot studies planned for 2021. Import approval is expected in
The
XPhyto's strategy is to develop a portfolio of generic and hybrid-generic drug products. The Company is reviewing its development pipeline for selection of its next near-term drug formulation candidate. As the Company looks to expand its near-term product pipeline it is reviewing numerous transdermal and oral dissolvable opportunities. The Company is also advancing its psychedelic medicine program and expects to make announcements with respect to API production and drug formulation in due course.
XPhyto's drug formulation business is carried out primarily by its 100% owned, German subsidiary,
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Forward-Looking Statements
This news release includes statements containing forward-looking information within the meaning of applicable Canadian securities law ("forward-looking statements"). Forward-looking statements are frequently characterized by words such as "develop", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "potential", "propose" and other similar words, or statements that certain events or conditions "may" or "will" occur, and in this release include the statement regarding the Company's goal of building a successful diagnostic, drug delivery, and medical cannabis company. Forward-looking statements are only predictions based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements, including: that the Company may not succeed in developing a commercial product; that the sale of products may not be a viable business; that the Company may be unable to scale its business; product liability risks; product regulatory risk; general economic conditions; adverse industry events; future legislative and regulatory developments; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; currency risks; competition; international risks; and other risks beyond the Company's control. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this news release.
SOURCE:
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https://www.accesswire.com/667674/XPhyto-Reports-Development-Update-for-its-Drug-Delivery-Business
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