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Pictured: Bayer's office in Berlin, Germany/iStock, Elenasfotos Bayer reported another Phase III win for its menopause drug candidate Tuesday, linking the molecule to improved outcomes in a long-term study and setting the stage for approval filings. The clinical trial evaluated the safety and efficacy of elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, in the treatment of hot flashes associated with menopause over 52 weeks. Bayer reported a pair of 12-week Phase III studies met their coprimary endpoints in January 2024, but still needed a hit on the third trial to show the long-term effects of the molecule. Bayer’s topline readout revealed that the trial met its primary endpoint, which tracked the mean change in the frequency of moderate to severe hot flashes after 12 weeks of oral daily dosing with elinzanetant or placebo. The company also said the safety pro across 52 weeks of dosing was consistent with the results of previously published studies including its Phase 2b dose-finding trial. The company plans to include data from all three clinical trials in applications for approval. If Bayer wins approval, it will face competition from Astellas’ rival NK3 receptor antagonist Veozah (fezolinetant). The FDA approved Veozah for the treatment of vasomotor symptoms, the medical term for hot flashes, due to menopause in May 2023. Bayer is keeping back data from all three trials to present at upcoming scientific congresses, making it impossible to assess how elinzanetant compares to Veozah. Astellas reported 3.6 billion yen ($24 million) of Veozah sales over the first nine months of its financial year and has run ads during the Super Bowl and the Oscars to promote the product. Elinzanetant may have an advantage over Veozah because it targets NK1 and NK3, rather than just the latter receptor. Some studies have suggested NK1 antagonists may improve sleep. Bayer’s long-term trial looked at changes in sleep disturbances, which are frequently associated with hot flashes, but the company has yet to release the data. The details of the readout will shape the prospects of an important molecule for Bayer. The company has 10 programs in Phase III development but CEO Bill Anderson has warned the “late-stage pipeline is thin relative to the patent losses we have in the next years,” telling the Financial Times that the problems stem from historical under-investment. Having stopped a Phase III trial of the investigational factor XIa inhibitor asundexian in November 2023, Bayer is looking to elinzanetant and late-phase prostate cancer and chronic kidney disease prospects to drive growth and offset the upcoming loss of patent protection for Xarelto (rivaroxaban). Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

SAN DIEGO & SHANGHAI--(BUSINESS WIRE)-- Sirius Therapeutics, announced it has dosed the first subject in a Phase 1, first-in-human clinical trial in Australia of SRSD107 on January 30th 2024, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. SRSD107 is the second clinical candidate in the company’s portfolio of next generation siRNA therapeutics to treat cardiovascular diseases. The company recently began clinical trials of SRSD101 in China for the treatment of dyslipidemia following IND clearance from the China National Medical Products Administration. “This trial is based on in vivo studies that demonstrated a nearly 100% reduction of FXI levels for up to 6 months, without bleeding events, after a single subcutaneous dose,” said Dr. Qunsheng Ji, Sirius Therapeutics’ Chief Executive Officer. “The trial will provide an opportunity to evaluate SRSD107’s potential as a differentiated therapeutic for these common disorders globally.” The SRSD107 Phase 1 study, which is being conducted in healthy volunteers in Australia, will evaluate SRSD107’s safety, tolerability, pharmacokinetics, and pharmacodynamics at single ascending doses and multiple ascending doses. About Thromboembolic Disorders Thrombosis, or blood clot formation, is the common underlying mechanism of most cases of myocardial infarction, ischemic stroke, and venous thromboembolism. According to a study in The Lancet of regional and global mortality, thromboembolic disorders are estimated to cause 1 in 4 deaths worldwide1. About SRSD107 SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed by Sirius Therapeutics, SRSD107 specifically targets coagulation factor XI (FXI) mRNA and inhibits FXI protein expression, thereby blocking the intrinsic coagulation pathway and promoting anticoagulant/anti-thrombotic effects. SRSD107 has been engineered for the potential to enable once or twice-a-year dosing. About Sirius Therapeutics Sirius is an innovative, clinical stage biotech company developing next generation siRNA therapy for global markets. We are dedicated to discovering and developing new treatment options for cardiovascular disease patients. Our most advanced products are SRSD107 for the treatment of thromboembolic disorders, and SRSD101 for the treatment of dyslipidemia. Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovative discovery center in the United States and translational medicine center in China. Sirius has raised nearly US$100 million funding to date from OrbiMed, Creacion Ventures, Hankang Capital, Delos Capital, and the leadership team. [1] Lozano R, Naghavi M, Foreman K, et al. Lancet. 2012;380, 2095-1128. View source version on businesswire.com: Contacts info@siriusrna.com Official Website: Source: Sirius Therapeutics View this news release online at:

Pictured: Bayer's office in Berlin, Germany/iStock, Elenasfotos Bayer on Wednesday revealed a new operating model meant to cut back on bureaucracy and hierarchies, as well as streamline the company’s structures, in an effort to boost its operational efficiency. The model, dubbed Dynamic Shared Ownership (DSO), is designed to “make the company much more agile,” according to Bayer’s announcement. The restructuring initiative will include job cuts over the next couple of months to be completed by the end of 2025, at the latest. “In line with the principles of DSO, the implementation will be largely decentralized, meaning that its scope cannot be quantified for the time being,” according to the company. Bayer employs some 22,200 staff in Germany and, as of the end of 2023, had a global headcount of more than 101,000. Though Bayer has not specified how many posts the layoffs will affect, Barbara Gansewendt, chairwoman of the Group Executives’ Committee at the company, said in a statement that it “will come at the expense of many managerial employees.” The committee represents the interests of manager-level staff at Bayer. Gansewendt called these layoffs an “extremely bitter development” for Bayer, adding that there is “no viable alternative” for the company. Affected staff will receive an “attractive” severance pay and will be given adequate support to help them find “new employment as quickly as possible,” she said. The new DSO operating model comes after new Bayer CEO Bill Anderson hinted at major structural changes during its third-quarter earnings report in November 2023. At the time, Anderson was expressed disappointment in the company’s performance, pointing to its “zero cash flow” which he called “simply not acceptable.” A Roche alum, Anderson won his seat at Bayer in February 2023, with the unanimous support of the company’s supervisory board. He formally assumed the helm in June 2023. Anderson inherits from the previous CEO—Werner Baumann, who had served Bayer for 35 years—a company reeling from the disastrous acquisition of the agricultural giant Monsanto. The buyout, signed in September 2016 for $66 billion, was at the time touted by Baumann as a “major step forward” for the company’s crop science business. In the years that followed, however, Monsanto’s weed-killer Roundup would be plagued by claims of cancer, ultimately racking up more than 42,000 lawsuits for Bayer. In its third-quarter 2023 financial report, Bayer posted a net debt of around $42.18 billion. Beyond the Monsanto debacle, Bayer’s pharmaceuticals business also suffered major setbacks last year. In November 2023, the company voluntarily pulled its follicular lymphoma therapy Aliqopa (copanlisib) from the U.S. market after it failed its confirmatory Phase III study. Aliqopa was given accelerated approval in September 2017. A few days later, Bayer decided to pull the plug on the Phase III OCEANIC-AF study of its inhibitor factor XIa asundexian after an Independent Data Monitoring Committee found that it had “inferior efficacy” to BMS and Pfizer’s Eliquis (apixaban). Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.