The data show the rapid and sustained suppression of free TL1A, confirming the target engagement of anti-TL1A (TEV-'574), and show a well-tolerated safety profile in patients with asthma, which support continued clinical investigation for moderate-to-severe inflammatory bowel disease (IBD); this includes ulcerative colitis (UC) and Crohn's disease (CD).1-3 These findings will be presented at the 19th Annual
'These results from the first-in-human trials of anti-TL1A (TEV-'574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated. This aligns with our extensive pre-clinical evidence and further supports ongoing clinical investigations of anti-TL1A (TEV-'574) in IBD, where TL1A plays a prominent role in amplification of immune response leading to burdensome inflammation and fibrosis in the gastrointestinal tract,' said Dr.
First-in-human pharmacokinetic and safety data for anti-TL1A (TEV-'574) from a Phase 1 study in healthy volunteers and patients with mild asthma and a Phase 2 study in patients with severe asthma show: Dose-proportional increases in anti-TL1A (TEV-'574) exposure and minimal accumulation after multiple dosing every two weeks.
A rapid and prolonged decrease in free TL1A levels indicating successful target engagement. This decrease was sustained up to two months after the last dose despite low or undetectable anti-TL1A (TEV-'574) levels.
A favorable safety profile and well tolerated up to doses of 2300mg.
Also to be presented at ECCO 2024 is the study design of the RELIEVE UCCD Phase 2 trial investigating the efficacy and safety of anti-TL1A (TEV-'574) in patients with moderate-to-severe UC or CD.3 This first-ever basket study design for an IBD trial offers an efficient approach to help advance anti-TL1A (TEV-'574) to Phase 3 studies.
On
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is the term for two conditions Crohn's disease (CD) and ulcerative colitis (UC) characterized by chronic inflammation of the gastrointestinal (GI) tract.5 CD and UC are chronic inflammatory conditions in the GI tract characterized by repetitive cycles of relapses and remission. Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction. Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss. No cure exists for IBD the goal of treatment is to induce and maintain remission and prevent flares.6 Globally, 4.9 million cases of IBD have been identified, with incidence rising in several regions.7
About RELIEVE UCCD
RELIEVE UCCD is a 14-week Phase 2b, randomized, double-blind, dose-ranging study to determine the pharmacokinetics, efficacy, safety, and tolerability of anti-TL1A (TEV-'574) in adults with ulcerative colitis (UC) or Crohn's disease (CD). In the trial, patients who meet pre-specified inclusion criteria are randomized to subcutaneously receive either one of two anti-TL1A (TEV-'574) dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis [UC or CD] and previous exposure to advanced IBD therapy [biologics and small molecules]) for 14 weeks. Participants who complete the 14-week induction period have the option to enter the long-term extension (LTE), consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints for both the 14-week and 44-week LTE study are number of participants with moderate-to-severe UC who show clinical remission (as defined by the modified Mayo score) and the number of participants with moderate-to-severe CD who show an endoscopic response (as defined by the endoscopic score for CD). The trial includes sites in the
About Anti-TL1A (TEV-'574)
Anti-TL1A (TEV-'574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-'574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-'574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-'574) have not been reviewed by any regulatory authority.
About Teva
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully compete in the marketplace, including our ability to achieve expected results from investments in our product pipeline including to successfully develop and commercialize our anti-TL1A (TEV-'574) asset for the treatment of ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease; our exclusive collaboration with
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