Sibofimloc

A phase 2 study of sibofimloc was terminated in March due to recruitment difficulties. Takeda may have caught attention recently for ending work on its early-stage gene therapy R&D, but a close reading of the Japanese pharma’s latest earnings report reveals it has also culled a couple of gastrointestinal assets. The most notable removal in the full-year presentation (PDF) is Crohn’s disease candidate sibofimloc, which was being investigated in a phase 1 trial for the luminal version of the inflammatory bowel disease as well as a phase 2 study of Crohn’s disease of the ileum occurring after surgery. The phase 2 study was terminated due to an inability to recruit enough patients, according to the ClinicalTrials.gov entry, which was last updated in March. The gut-restricted, small-molecule FimH-blocker was designed to treat the underlying cause of Crohn's disease. The therapy was first created by Vertex Pharmaceuticals before being in-licensed by French biotech Enterome, to which Takeda paid $50 million upfront in 2018 to co-develop the therapy. Enterome has gone quiet on sibofimloc since 2021, when the company highlighted research into the drug demonstrating that “blocking the adhesion of overabundant FimH-expressing bacteria to the gut wall is a promising therapeutic mechanism that effectively disarms these virulent bacteria without killing them.” At the time, Takeda’s senior medical director for gastroenterology Vijay Yajnik, M.D., said the research showed “a very promising finding that it exerts its local anti-inflammatory action by blocking pathogenic bacteria without disrupting the commensal gut microbiome.” The demise of sibofimloc is far from the end of Takeda’s Crohn’s ambitions, however. The company, which already has Entyvio on the market for the condition, is planning to launch a phase 2b trial in Crohn’s for its potential psoriasis and arthritis treatment TAK-279 later this year. The other GI asset dumped from Takeda’s pipeline is TAK-954, which was in phase 2 development for postoperative gastrointestinal dysfunction. In an SEC filing to accompany its own earnings results this week, Theravance Biopharma—which licensed the drug to Takeda in 2016—explained that the two companies had mutually agreed to discontinue development of the selective 5-HT4 receptor agonist back in February after it failed the phase 2 study. Takeda’s full-year earnings documents also reaffirmed that the company is dropping its early-stage R&D work in adeno-associated virus-based gene therapies. It was revealed this week that as many as 186 jobs in the pharma’s Massachusetts sites are set to go as a result. The gene therapy retreat could also have an impact on some of Takeda’s partners. In its own earnings report this week, Poseida Therapeutics said it was “in discussions with Takeda about our collaboration following the news that they have made some strategic decisions in their research priorities and will update when appropriate.”

Headline results for the fourth fiscal quarter: Revenue: JPY 956.2 billion ($7.1 billion), up 9.5% Profit: JPY 31.1 billion ($231 million), versus a loss of JPY 11.4 billionNote: All changes are versus the prior-year period unless otherwise statedWhat the company said:Chief financial officer Costa Saroukos noted that "our top-line and profit performance was driven by our growth and launch products, which grew 19% at constant exchange rate." Saroukos added "I'm pleased to report that Takeda delivered or exceeded management guidance in FY2022 and booked a record core operating profit of almost JPY 1.2 trillion."Other results: Gastroenterology product sales: JPY 237 billion, up 12.9% Entyvio: JPY 154.9 billion, up 22.5% Takecab/Vocinti: JPY 24.2 billion, up 0.6% Rare diseases product sales: JPY 169.8 billion, up 14.5% Rare haematology product sales: JPY 72.1 billion, flat versus the prior year Advate: JPY 26.1 billion, down 10.6% Rare genetics product sales: JPY 97.8 billion, up 28.3% Takhzyro: JPY 34.9 billion, up 40.7% Plasma-derived therapy/immunology sales: JPY 176 billion, up 22.5% Neuroscience product sales: JPY 160.6 billion, up 34.2% Vyvanse/Elvanse: JPY 123.8 billion, up 50.9% Trintellix: JPY 20.4 billion, up 5.7% Oncology product sales: JPY 93.8 billion, down 14.5% Ninlaro: JPY 16.8 billion, down 18.1% Adcetris: JPY 18.2 billion, up 4.3% Velcade: JPY 3 billion, down 88.2% Full-year revenue: JPY 4 trillion, up 12.8% Full-year profit: JPY 317 billion, up 37.8%Looking ahead:CEO Christophe Weber said "while we expect to face temporary headwinds in FY2023 from generic entrants and lower demand for coronavirus vaccines, we are confident that strong momentum in our growth and launch products will drive a return to growth in the near-term."Takeda expects sales in fiscal year 2023 of JPY 3.8 trillion ($28.2 billion), representing a 4.7% decline versus the prior 12-month period, with revenue from Entyvio jumping 15% to JPY 788 billion ($5.8 billion). Meanwhile, operating profit is forecast to fall 28.8% to JPY 349 billion ($2.6 billion).($1 = JPY 134.730)