The U.S. Food and Drug Administration (FDA) has granted clearance for NovelMed Therapeutics’ ruxoprubart (NM8074), an investigational drug, to begin an efficacy Phase II trial to treat dermatomyositis (DM).
This announcement follows the successful completion of a Phase I clinical trial involving 40 healthy volunteers, where ruxoprubart demonstrated promising results and a clean safety profile, with no serious adverse events reported.
“Our team is thrilled with the early success of ruxoprubart in clinical trials,” says Rekha Bansal, PhD, Founder and CEO of NovelMed Therapeutics, in a news release. “Dermatomyositis is a condition that causes significant physical and emotional suffering for patients, and we believe Ruxoprubart has the potential to offer real hope for improved treatment outcomes. This is a pivotal step in our mission to advance therapies for rare diseases and extend our leadership in complement-based therapeutics.”
Current treatment options for DM remain limited, with corticosteroids and immunosuppressive agents, which carry significant side effects. While the FDA has approved intravenous immunoglobulin (IVIg) in combination with corticosteroids for DM, there remains a critical need for safer and more effective therapies.
“The FDA’s IND approval for our Phase II trial in Dermatomyositis is an exciting milestone,” adds Mr. Robert Bard, VP of Regulatory Affairs at NovelMed Therapeutics. “Current treatments rely heavily on corticosteroids and immunosuppressive agents, which come with significant safety risks. Ruxoprubart has the potential to redefine the standard of care by targeting a key driver of inflammation while avoiding broad immunosuppression.”
