Anifrolumab-FNIA

The full results from AstraZeneca's phase 3 Tulip-SC trial build on the interim results that earned the drug a European approval last month. Fresh off of a European approval for a subcutaneous version of Saphnelo, AstraZeneca is doubling down on the benefits of the self-administered drug formulation in lupus patients with a positive phase 3 showing.In the phase 3 Tulip-SC trial, 56.2% of patients with systemic lupus erythematosus (SLE) who received a subcutaneous dose of Saphnelo experienced a reduction in disease activity at week 52, the company reported Tuesday. In the placebo group, the result was 37.1%.The readout adds more detail to the trial's prior interim analysis, which confirmed a statistically significant result for subcutaneous Saphnelo and a safety profile on par with the currently marketed intravenous infusion version. Subcutaneous Saphnelo also met the bar across a range of secondary endpoints in the trial, many of which use the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) as a measure of disease activity.AstraZeneca found that more patients (41.5%) achieved a faster BICLA response with SC Saphnelo than with placebo, and that those in the treatment group had a longer delay to their first disease flare-up.Additional pre-specified secondary and exploratory endpoints, 40.1% of patients on treatment attained low-level disease activity and 29% achieved DORIS remission at week 52, as did 14.7% on placebo. Recently revised treatment guidance for SLE positions DORIS remission, which is a remission definition established by the DORIS Task Force, as the primary goal of care, AstraZeneca notes.“These results reinforce Saphnelo’s unique approach of targeting the type 1 interferon receptor to reduce disease activity, with the added convenience of subcutaneous self-administration,” Sharon Barr, EVP of R&D at AstraZeneca, said in a company release. “The TULIP-SC findings build on the compelling body of evidence for Saphnelo, which has helped patients achieve remission and significantly reduce reliance on oral corticosteroids—further reinforcing our ambition to transform lupus care.” Tapering toward chronic oral corticosteroids (OCS) discontinuation is another recent addition to lupus treatment recommendations, putting AZ’s results in line with the key changes to the global standards, the company explained in the release. Saphnelo, as an IV infusion, won FDA approval in 2021, breaking a 10-year treatment drought in SLE after GSK’s 2011 nod for Benlysta. The nod came after a phase 3 trial found that Saphnelo didn’t outperform placebo on a disease response measure called the SLE Responder Index 4, prompting AZ to pivot to the BICLA marker for its next study.Over 3.4 million people globally are impacted by SLE, and the disease is one of the leading causes of death in young women in the U.S., according to the company. AZ hopes to reach more of those patients through its more convenient, subcutaneous version of Saphnelo. European regulators were the first to approve Saphnelo as a once-weekly, pre-filled pen in December, while regulatory applications in other countries, including the U.S. and Japan, are under review.The new formulation could be key to catching up with GSK’s Benlysta, which was approved as a self-injectable treatment option in 2017. With a ten-year lead on Saphnelo, Benlysta remains the one to beat in the SLE field, touting blockbuster sales in 2024 compared to Saphnelo’s $474 million.However, Spherix Global Insights analysts note that the lupus treatment landscape is “poised for evolution,” noting that Biogen’s experimental litifilimab is an “especially strong competitor” to the two existing offerings from AZ and GSK. 

The Fund Will be Managed by Experienced Life Sciences Investor Nishant Rastogi NEW YORK, Jan. 6, 2026 /PRNewswire/ -- Today, the Lupus Research Alliance, the world's largest private funder of lupus research, announced the formation of a new philanthropic venture fund Lupus Ventures. The Fund is dedicated to advancing treatments and diagnostics for systemic lupus erythematosus (SLE), its manifestations, and related autoimmune conditions. Continue Reading Lupus Ventures aims to accelerate the development of new treatments and diagnostics that can improve the standard of care and deliver meaningful value to the millions of people living with lupus worldwide. Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. Treatment development stagnated for years after the U.S. Food and Drug Administration approved Benlysta® in 2011. However, with the approvals of Saphnelo® and Lupkynis® in 2021, and Gazyva® in October 2025, the tides are turning. Innovative treatments like engineered cell therapies are showing great promise, and there are over 140 lupus therapies in clinical trials today from more than 120 companies. With that promise, philanthropic investment in higher-risk, early-stage companies is increasingly powerful. Lupus Ventures aims to bridge the gap between innovative science and commercial reality. "The Lupus Research Alliance has spent years building a research engine that supports every part of the scientific process — from basic and translational research through clinical development," Albert T. Roy, President & CEO of the Lupus Research Alliance, said. "Launching Lupus Ventures is the natural — and critical — next step. It allows us to strategically deploy resources and catalyze solutions for people living with lupus, ensuring promising ideas don't sit on a shelf simply for lack of funding." Nishant Rastogi will serve as the Fund's inaugural Managing Director. Mr. Rastogi is an accomplished life sciences investor with more than a decade of biotech venture capital and private equity experience. He has served as a Board Director and operating partner for multiple biotech and medtech companies throughout his career. Before joining Lupus Ventures, Mr. Rastogi served as Vice President and Head of Transactions at New Rhein Healthcare Investors. He played an integral role in all aspects of the firm's evolution and growth — including investment activities, portfolio management, team building, and operations. He was involved in New Rhein's investments in Corsair (Director), Theranica, Alveus, American Injectables, Butterfly Medical, Softhale (acquired), Neuraptive, and others. Earlier in his career, Mr. Rastogi was an investor at Broadview Ventures and an analyst at Fidelity Investments. He has advised several disease research foundations — including Beyond Celiac, 90/10 Institute, and Parent Project Muscular Dystrophy — on venture fund formation and the role of philanthropy and private investment in advancing new medicines and health equity. Mr. Rastogi earned his BA from Dartmouth College and his MBA from Northwestern University. "I am grateful to the Lupus Research Alliance for the opportunity to build this platform," Mr. Rastogi said. "As the world's only investment fund dedicated to SLE, we are uniquely positioned to support companies developing potential therapies in this area to benefit people living with lupus globally. The combination of recent scientific advancements and investor and industry interest makes this a perfect time to launch the Fund." All companies — regardless of modality or stage of development — are being considered for investment. In addition to capital, the companies will also receive counsel and guidance, leveraging the Lupus Research Alliance's depth of knowledge gained through its industry leadership. To date, the Lupus Research Alliance has awarded more than $284 million across 650+ research grants, and clinical affiliate Lupus Therapeutics is involved in 25-30% of active clinical trials. The Fund will be overseen by the Investment Committee that includes Mr. Rastogi, Mr. Roy and Ira Akselrad, President and CEO of The Johnson Company, Inc. and Chair of the Lupus Research Alliance Board of Directors. Teodora Staeva, PhD, Chief Scientific Officer of the Lupus Research Alliance, will serve on its Scientific Advisory Board. The Fund plans to recruit additional experts to the Investment Committee, Scientific Advisory Board, and investment team in 2026. To learn more about Lupus Ventures, visit . About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body's own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs, and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15-45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus. About Lupus Ventures Lupus Ventures (dba "The Lupus Venture Fund") is the venture investment fund of the Lupus Research Alliance. The Fund is dedicated to advancing treatment and diagnostic options for systemic lupus erythematosus (SLE), its manifestations, and related autoimmune conditions. The Fund defines success as improving the standard of care and delivering meaningful value to the millions of people living with lupus worldwide. Visit for more information. About the Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering scientific talent, and driving discovery toward better diagnostics, improved treatments and, ultimately, a cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. For more information or to donate to lupus research, visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram. SOURCE Lupus Research Alliance 21% more press release views with Request a Demo