XPhyto Therapeutics Corp. (CSE:XPHY, OTCQB:XPHYF) announced that its drug formulation and development business is advancing “multiple generic and hybrid-generic programs” for neurotherapeutics.
In a development update, XPhyto said its drug formulation business is focused on “scalable, low-cost” development opportunities that have “expedited pathways” to regulatory approval.
"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 4Q 2021 and 1Q 2022," XPhyto CEO Hugh Rogers said in a statement.
READ: XPhyto advances its Rotigotine drug delivery system for Parkinson's skin patches to a pivotal human trial
"We are also looking to expand our near-term product pipeline beyond neurotherapeutics and are expecting considerable synergies with other XPhyto business lines by applying our drug delivery expertise to psychedelic compounds and to delivering biosensors via our proprietary oral dissolvable platform."
XPhyto said its German subsidiary Vektor Pharma TF GmbH focused on a human bioavailability pilot study of Rotigotine transdermal patches for Parkinson's disease during the first quarter. Based on the study completed in March, XPhyto has advanced its generic neurologic drug Rotigotine transdermal product to formula optimization.
“The optimization process, expected to be completed in 4Q 2021, is carried out to finalize the product in anticipation of a pivotal clinical study in 2Q 2022,” said the company.
Data from the pivotal trial will form the basis for the company's European regulatory application. “Preparation for contract manufacturing, sales and marketing is being done simultaneously to ensure rapid and efficient market launch, subject to a successful pivotal trial,” it said.
Rotigotine is approved for the treatment of Parkinson's disease and restless legs syndrome in Europe and the United States. Rotigotine, the active pharmaceutical ingredient, is a generic "off-patent" drug that is typically formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours.
The global transdermal skin patches market reached nearly US$6.5 billion in 2020, having increased at a compound annual growth rate of 3.9% since 2015, according to Research and Markets. The market is expected to grow to US$7.9 billion in 2025 and reach US$9.39 billion in 2030.
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 R&D efficiencies as knowledge gained in each program has been utilized in the others, including patentable technological advancements in the company's ODF platform,” said XPhyto.
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, it added. Import approval is expected in November 2021 with the CBD pilot study to start immediately thereafter. Study planning and clinical product manufacturing is complete.
The US Food & Drug Administration and European Medicines Agency have approved CBD-based medicines for treating childhood epilepsy, specifically Dravet syndrome and Lennox-Gastaut syndrome. THC-based medicines have also been approved for nausea associated with cancer chemotherapy and for the treatment of anorexia associated with AIDS patients.
“The registered formulation for CBD is a lipophilic solution in sesame oil and for THC it is a soft gelatin capsule filled with THC in a sesame oil carrier,” said the company.
The company said it is 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 by its German subsidiary Vektor Pharma TF GmbH based in Biberach, Baden-Württemberg. It is a leader in thin film drug formulations, particularly transdermal patches, and oral strips for the delivery of pharmaceutical ingredients for treating pain and neurological conditions.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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