Press Release: EADV: Sanofi's brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study

EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study In phase 2a study, brivekimig led to clinically meaningful improvements in primary and key secondary endpoints in biologic-naïve patients compared to placebo at week 16Dual-target Nanobody® VHH inhibiting TNF and OX40L being explored across a range of immune-mediated diseasesReaffirms Sanofi’s commitment to addressing underlying inflammation across complex, heterogeneous chronic skin diseases Paris, September 17, 2025. New data from the HS-OBTAIN phase 2a study (clinical study identifier: NCT05849922) show that treatment with brivekimig led to clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) in patients naïve to biologics with moderate-to-severe hidradenitis suppurativa (HS). Brivekimig was well tolerated, with no serious adverse events. The results will be shared in an oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris. HS is a chronic and debilitating inflammatory skin disease characterized by painful cutaneous nodules, abscesses and draining tunnels. Approximately 196,000 adults in the EU live with HS. “Despite the debilitating impact of HS, treatment options are unfortunately limited,” said Alexa B. Kimball, MD, MPH, Professor of Dermatology, Harvard Medical School. “The phase 2a results presented at EADV indicate targeting TNF and OX40L pathways together with brivekimig may offer a promising strategy to reduce underlying inflammation, leading to improvement in HS symptoms.” Key resultsThe HS-OBTAIN phase 2a study is a randomized, double-blind, placebo-controlled, proof-of-concept study assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS. The primary analysis population included biologic-naïve HS patients who were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks. The following was observed at 16 weeks: HiSCR50, defined as ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline, median response rates were 67% in the brivekimig arm (n=48) versus 37% (n=23) in the placebo arm (Bayesian primary analysis with estimated difference of 29%; 90% credible interval: 10%–47%; probability of superiority: 99.28%).Clinically meaningful improvements were also seen in more stringent secondary efficacy endpoints of HiSCR75 and HiSCR90 for brivekimig versus placebo.54% of patients treated with brivekimig achieved HiSCR75 versus 22% with placebo (estimated difference of 29%; 90% confidence interval [CI]: 11%–48%; p=0.0171).HiSCR90 was achieved by 31% of patients treated with brivekimig versus 9% with placebo (estimated difference of 20%; 90% CI: 5%–34%; p=0.0576).The mean percent change from baseline in draining tunnel count was -56.0% for brivekimig versus +10.9% for placebo (estimated difference of -67.0%; 90% CI: -105.2% to -28.8%; p=0.005). The most frequent adverse events (occurring in >10% of participants, and more frequent with brivekimig than with placebo) were nasopharyngitis and headache. “The positive early-stage results for brivekimig in HS presented at EADV exemplify our deep understanding of pathway biology and commitment to exploring novel platforms and technologies with the goal of delivering new treatment options that can address the complex, heterogeneous nature of chronic inflammatory skin diseases,” said Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. “We are encouraged by these results and look forward to continuing to explore brivekimig, and the impact of dual TNF and OX40 ligand inhibition, on the inflammation driving the burdensome symptoms of HS.” The use of brivekimig to treat HS is investigational and has not been evaluated by any regulatory authority. About brivekimig Brivekimig is a dual-target Nanobody® molecule inhibiting the tumor necrosis factor and OX40-ligand, key immune regulators. It is being investigated for potential uses across a range of immune-mediated diseases and inflammatory disorders. About the HS-OBTAIN StudyHS-OBTAIN (clinical study identifier: NCT05849922) is a randomized, double-blind, placebo-controlled, proof-of-concept phase 2a study assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS. Patients were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks for 16 weeks, followed by a 12-week open-label period and an 8-week safety follow-up. The primary efficacy endpoint was the percentage of biologic-naïve participants achieving HiSCR50 at week 16. The primary analysis was based on a Bayesian logistic regression model adjusted for Hurley Stage. Additional endpoints included HiSCR75, HiSCR90, and draining tunnel count at week 16 (with adjusted estimates and nominal p-values). About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Investor RelationsThomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Dr. Kimball receives compensation for consulting and unpatented licensing fees from Sanofi. Press Release

Press Release: EADV: Sanofi's brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study

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