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Immunic, Inc. (NASDAQ:IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 18/529,946, entitled, "Treatment of multiple sclerosis comprising DHODH inhibitors."
Specifically, the resulting patent covers dose strengths associated with lead asset, vidofludimus calcium (IMU-838), and other salt forms as well as free acid forms, at a daily dose of about 10 mg to 45 mg, for the treatment of progressive multiple sclerosis (PMS), including the sub-groups primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS). The patent is expected to provide protection into 2041, and potential Patent Term Extension may offer additional market exclusivity in the United States.
"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," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The patent comes at a pivotal time, closely on the heels of our positive phase 2 CALLIPER trial data in PMS. Vidofludimus calcium continued to demonstrate neuroprotective potential by delaying time to 24-week confirmed disability worsening (24wCDW), supporting its ability to slow disease progression in multiple sclerosis patients, with or without focal inflammation. These findings also reinforce the reductions in the annualized rate of thalamic brain volume loss and volume of new/enlarging T2 lesions seen in the CALLIPER trial. Given that 24wCDW would be an acceptable regulatory endpoint of a pivotal phase 3 trial, 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."
Vidofludimus calcium is covered by several layers of granted patents in the United States, Europe and other jurisdictions around the world. These patents are directed towards composition-of-matter for salt forms of vidofludimus, including the specific calcium salt form used in Immunic's clinical trials; the treatment of relapsing multiple sclerosis and progressive multiple sclerosis with a specific dose strength used in the clinical trials; the dosing regimens, including those used in clinical trials for the treatment of multiple sclerosis, as well as composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material. In the United States, these patents provide protection into 2041, or even beyond. In addition, a pending application is directed towards the use of vidofludimus calcium and other salt forms as well as free acid forms for treating neurodegenerative diseases. If granted, this application could provide protection up to 2044, unless extended further. Finally, further undisclosed patent applications dedicated to strengthening the exclusivity period are currently in process. On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection.
Posted In: IMUX
