CLINICAL TRIAL – FirstFlash

July 21, 2025 - Sun Pharmaceutical Industries, India's largest drug maker, announced today that its psoriasis medication ILUMYA has successfully completed two major clinical trials for treating psoriatic arthritis, a painful joint condition that affects millions worldwide. The positive results from the INSPIRE-1 and INSPIRE-2 studies represent a significant milestone that could lead to expanded treatment options for patients suffering from this debilitating autoimmune disease. Psoriatic arthritis is a chronic inflammatory condition that causes swelling, pain, and stiffness in joints and surrounding tissues. Unlike regular arthritis, this disease is linked to psoriasis, a skin condition that causes red, scaly patches. About one in three people with psoriasis also develop psoriatic arthritis, though the joint disease can occur regardless of how severe the skin symptoms are. The condition affects approximately 2.4 million Americans, but experts believe more than 15% of psoriasis patients may have undiagnosed psoriatic arthritis. The disease can develop at any age and significantly impacts patients' quality of life and mobility. ILUMYA (pronounced "ih-LOOM-yah") is currently approved in the United States and other countries for treating moderate-to-severe plaque psoriasis. The drug works by targeting a specific protein called interleukin-23 (IL-23) that plays a key role in inflammatory responses. The medication is what scientists call a "monoclonal antibody" - essentially a laboratory-created protein designed to bind to and block specific targets in the immune system that drive inflammation. By inhibiting IL-23, ILUMYA helps reduce the inflammatory cascade that causes both skin and joint symptoms. Trial Results The two Phase 3 clinical trials enrolled over 800 adult patients from medical centers across the United States, Europe, and Asia. Participants were randomly assigned to receive either ILUMYA or a placebo (inactive treatment) every 12 weeks for 24 weeks. The studies measured success using the ACR20 response - a standard benchmark in arthritis research that looks for at least 20% improvement in both joint tenderness and swelling, plus improvement in three additional measures like pain levels and physical function. Key findings: Both studies met their primary goal of showing statistically significant improvement compared to placebo Patients receiving ILUMYA experienced greater reductions in joint pain and swelling at 24 weeks The safety profile was consistent with the drug's known effects from psoriasis treatment No new safety concerns were identified The INSPIRE-1 trial specifically studied patients who had previously tried anti-TNF medications (another class of arthritis drugs), while INSPIRE-2 included patients who had never used these treatments. "We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints," said Dr. Marek Honczarenko, Senior Vice President and Head of Global Specialty Development at Sun Pharma. "These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis." The results are particularly significant because psoriatic arthritis can be challenging to treat, and patients often need multiple medication options. Currently available treatments include anti-TNF drugs, other biologics, and traditional disease-modifying drugs, but not all patients respond to these therapies or can tolerate their side effects. What Happens Next Sun Pharma plans to present the complete study data at upcoming medical conferences and submit the findings to peer-reviewed medical journals. The company indicated these results support a potential regulatory submission to the U.S. Food and Drug Administration (FDA) for approval of ILUMYA in treating psoriatic arthritis. However, patients should note that ILUMYA is not currently approved for psoriatic arthritis treatment, and the drug's safety and effectiveness for this condition have not yet been evaluated by regulatory authorities. If approved, ILUMYA would provide another treatment option in an area where patients often struggle to find effective therapies. The drug's every-12-week dosing schedule could also offer convenience advantages over some existing treatments that require more frequent injections. Sun Pharma is a global pharmaceutical company headquartered in Mumbai, India, with operations spanning six continents. The company is the world's leading specialty generics manufacturer and India's largest pharmaceutical company. It also ranks as a leading generic drug company in the United States and other emerging markets. The company's specialty portfolio, which includes innovative products in dermatology, ophthalmology, and cancer treatment, accounts for about 20% of its sales. Sun Pharma's medicines are trusted by physicians and consumers in over 100 countries. The pharmaceutical industry has seen significant advances in treating autoimmune conditions like psoriatic arthritis over the past two decades. The success of ILUMYA in these trials adds to the growing arsenal of targeted therapies that offer hope for patients with these chronic, debilitating conditions. For patients currently managing psoriatic arthritis, these results represent potential future treatment options, though regulatory approval and market availability remain pending. Healthcare providers emphasize the importance of working with rheumatologists and dermatologists to optimize current treatment strategies while monitoring developments in new therapies.

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