Cipher Pharmaceuticals Inc., a company specializing in pharmaceuticals and boasting a wide range of commercialized as well as early to advanced stage products, has disclosed that its collaborator, Moberg Pharma AB, has released a statement indicating that MOB-015, a treatment intended for nail fungus, did not successfully meet its main goals in the phase 3 study conducted in North America by Moberg.
The outcomes of this North American phase 3 trial, as reported by Moberg, align with initial projections shared earlier by the company, resulting in a corresponding announcement from Cipher on September 13, 2024.
During the North American phase 3 trial, the treatment regimen was altered – consisting of daily doses for 8 weeks followed by weekly maintenance for an additional 40 weeks, in contrast with continuous daily dosing throughout. The primary objective, to attain a full cure of the patient’s target toenail within 52 weeks, was not met. Achieving a complete cure necessitates both a visibly clear nail and a mycological cure.
Through a licensing agreement dated September 18, 2018, Cipher holds exclusive Canadian marketing rights for Moberg’s MOB-015, empowering them to commercialize, promote, sell, and distribute the product within Canada. Cipher bears no additional financial responsibilities related to the Agreement should the necessary development and regulatory milestones not be accomplished.
Cipher plans to assess and analyze the full trial outcomes once provided by Moberg, guiding their decision about advancing with this particular product. Nonetheless, this does not impact the current revenue and profit structure of Cipher’s established operations.
The company remains dedicated to its recent procurement of the Natroba business from ParaPRO LLC, announced on July 29, 2024, alongside exploring other growth possibilities. Cipher perceives considerable growth potential for Natroba in the US and other international arenas. Integrating this venture into its prosperous North American framework and pursuing further growth prospects remain central to Cipher’s strategic priorities in the forthcoming period.