#United States #New York #Multiple Sclerosis #Immunic #Vidofludimus

Immunic's Latest Patent Approval: A Game Changer for Multiple Sclerosis Treatment

Immunic, Inc., a prominent player in biotechnology, has recently achieved a significant milestone in its efforts to combat chronic inflammatory and autoimmune diseases. The company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled "Treatment of multiple sclerosis comprising DHODH inhibitors," notably covering the effective dose strengths of its lead candidate, Vidofludimus Calcium (IMU-838), in treating progressive multiple sclerosis (PMS).

This patent grants Immunic protection over various dosages, ranging from 10 mg to 45 mg of Vidofludimus Calcium, specifically for treating both primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS). With patent coverage extending to 2041, Immunic ensures that it holds a robust market position in the treatment of these often debilitating conditions.

Significance of the Patent

Daniel Vitt, CEO of Immunic, expressed that the allowance of this patent bolsters the company's comprehensive intellectual property strategy, highlighting the strong and multi-layered nature of their portfolio. This approval comes in the wake of promising results from the phase 2 CALLIPER trial, where Vidofludimus Calcium demonstrated potential neuroprotective effects by delaying significant deterioration in patients’ conditions. This data not only marks a pivotal point for the treatment of PMS but also aligns with the regulatory standards needed for advancing to a pivotal phase 3 trial.

Clinical Implications and Next Steps

The CALLIPER trial revealed significant reductions in brain volume loss and the appearances of new or enlarging lesions, reinforcing the therapeutic potential of Vidofludimus Calcium. The positive outcomes related to the 24-week confirmed disability worsening (24wCDW) benchmark highlight the necessity for further discussions with healthcare authorities to strategize the pathway towards making this innovative treatment available to patients suffering from progressive forms of multiple sclerosis, where there remains a critical medical gap.

Vidofludimus Calcium: A Closer Look

Vidofludimus Calcium is a first-in-class oral therapy aimed at progressive forms of multiple sclerosis and other chronic autoimmune diseases. It employs a dual mode of action, providing not just neuroprotective but also anti-inflammatory and anti-viral benefits by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). This distinct approach allows it to target the multifaceted nature of multiple sclerosis effectively.

The drug has shown promising results in previous trials, having treated around 2,700 patients with an excellent safety profile. In addition to its clinical efficacy regarding relapsing forms of MS, Vidofludimus Calcium has exhibited substantial benefits in patients with progressive forms, demonstrating significant correlations with reduced disability and improvements in brain health.

The Bigger Picture

Immunic has diligently built a protective wall around Vidofludimus Calcium, with various granted patents in jurisdictions across the US and Europe. Aside from the current patent extending coverage into 2041, another application aims to secure protection until 2044 depending on future developments. This proactive approach illustrates Immunic's commitment to safeguarding its innovations and the potential they hold for the future of MS treatment.

As awareness grows surrounding autoimmune disorders and the needs of affected individuals, Immunic’s strategic advancements offer hope and could soon lead to a breakthrough in how progressive multiple sclerosis is treated. With an eye on the horizon for further clinical trials and potential market approval, Immunic is poised to be at the forefront of developing innovative therapies that effectively address the shifting landscape of patient care in this area.

To find out more about Immunic, Inc. and the exciting developments concerning Vidofludimus Calcium, visit their website at www.imux.com.