Immunic Inc (NASDAQ:IMUX) announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) covering dose strengths of its lead asset, vidofludimus calcium (IMU-838), for the treatment of progressive multiple sclerosis (PMS).
The patent, tied to application 18/529,946, protects daily dosing of about 10 mg to 45 mg of vidofludimus calcium, including other salt and free acid forms, for patients with primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS).
It is expected to remain in force until 2041, with the possibility of extension.
"Allowance of this new key patent represents a significant advancement for our vidofludimus calcium program in PMS and further strengthens its robust, multi-layered intellectual property portfolio," Immunic CEO Dr Daniel Vitt said
This marks the fifth US patent granted to Immunic directed toward vidofludimus calcium in multiple sclerosis.
The company said the drug candidate is already supported by multiple layers of intellectual property across the US, Europe and other markets.
These include patents covering composition-of-matter for salt forms of vidofludimus, treatment of both relapsing and progressive MS at specific dose strengths, dosing regimens tested in clinical trials, as well as composition-of-matter for a polymorph of vidofludimus calcium and a related production method. According to Immunic, these protections extend into 2041 or beyond.
A separate pending application covering the use of vidofludimus calcium for neurodegenerative diseases could, if approved, provide coverage until 2044. The company also noted additional undisclosed applications remain under review.
In addition to patent exclusivity, Immunic said vidofludimus calcium, classified as a new chemical entity, should qualify for regulatory data protection in the US and other jurisdictions.
“We look forward to continuing to discuss the opportunity with healthcare authorities to determine next steps toward our goal of bringing this novel and exciting approach to patients with progressive forms of multiple sclerosis, where there continues to be a significant unmet medical need,” Dr Vitt concluded.