Specialty pharmaceutical company iX Biopharma has released updates on two of its key strategic growth drivers: Wafermine, sublingual ketamine wafers; and iXB 401, sublingual semaglutide wafers.
On the back of the group’s termination of its licensing agreement with Seelos Therapeutics earlier this year, iX Biopharma says in a Sept 16 bourse filing that it has made “significant strides” in advancing Wafermine’s out-licensing efforts.
According to the group, these efforts include the preparation of comprehensive marketing collateral, establishing a secure data room, selecting the right licensing advisors to assist in global out-licensing for Complex Regional Pain Syndrome (CRPS) and depressive disorders.
Following an “extensive” search, the group has since appointed Kybora, a US-based global life sciences advisory firm with expertise in licensing transactions, fundraising, and mergers and acquisitions (M&A), as advisor for the out-licensing of Wafermine.
With the appointment, iX Biopharma will begin engaging potential partners in the US, Europe and other key markets over the next quarter to explore licensing opportunities for Wafermine.
As CRPS is a rare condition, the group adds that the need for effective treatment is crucial due to the lack of approved existing therapies. As such, the group says that Wafermine’s potential to address this unmet medical need is underscored by its Orphan Drug Designation from the US Food and Drug Administration (FDA), which secures a seven-year market exclusivity post approval and development incentives.
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The group says: “Our strategy to focus Wafermine’s development on CRPS has been validated in discussions with advisors; prospective partners could include large pharmaceutical and specialty pharmaceutical companies focused on central nervous system (CNS) therapeutics, drug repurposing and/or rare diseases.”
Meanwhile, the group announced that it has made “meaningful progress” in the development of iXB 401, its sublingual semaglutide wafer for Type 2 diabetes and obesity.
The group has since developed various formulations using proprietary combinations of mucoadhesives, permeation enhancers and surfactants, and is now preparing to commence preclinical testing.
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A clinical research organisation has been appointed to conduct pharmacokinetic and pharmacodynamic studies using established in-vivo C57BL/6 and diabetic mouse models.
According to the group, these studies will help determine the optimal formulations to advance to human trials. Positive results in the mice studies will be significant in advancing the out-licensing of iXB 401 or securing partnerships to fund its next human clinical study.
Semaglutide, a GLP-1 receptor agonist, has been proven effective in managing Type 2 diabetes and obesity.
While the GLP-1 drug market is forecasted by GlobalData to reach US$125 billion ($161.90 billion) by 2030 due to strong demand, existing treatment options face challenges in patient preference, and bioavailability and variability, respectively.
The group says that iXB401 offers a solution to these concerns, while addressing the issue of growing demands for injectable GLP-1 medications outstripping supply.
iX Biopharma adds: “iXB 401 offers a novel solution that could address these issues, whilst enhancing patient compliance and reducing environmental impact.”
Shares in iX Biopharma closed flat at 2.6 cents on Sept 16.
