ELEVATE UC 52 met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints
– Etrasimod demonstrated a safety profile consistent with previous studies
Pfizer Inc. (NYSE: PFE) today announced positive top-line results from a second Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23.
In this 52-week study, also known as ELEVATE UC 52, etrasimod patients achieved statistically significant improvements in the co-primary endpoints of clinical remission at weeks 12 and 52 when compared to placebo. Statistically significant improvements were attained in all key secondary endpoints at both 12 and 52 weeks. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial.
The global Phase 3 multi-center, randomized, double-blind, placebo-controlled study enrolled 433 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Participants received etrasimod 2 mg or placebo once-daily. ELEVATE UC 52 utilized a treat-through design in which patients were eligible to continue with their randomized treatment independent of whether they reached the objective criteria of clinical response at week 12.
“For patients suffering with moderate to severe ulcerative colitis, these most recent data further demonstrate the substantial potential benefits of this medicine and clearly confirm its ability to achieve significant induction of remission at 12 weeks and now clinical remission at week 52. These data underscore etrasimod’s potential, if approved, as a best-in-class therapy,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “Etrasimod can potentially provide a new, once-daily, oral option with a rapid onset of action and without first dose titration.
Full results from the studies will be submitted for future scientific publication and presentation. These data, along with results from ELEVATE UC 12 and the long-term extension from these two trials (ELEVATE UC OLE), are expected to form the basis for planned future regulatory filings.
Etrasimod was developed by Arena Pharmaceuticals, which was recently acquired by Pfizer.
Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. It is being investigated for a range of immuno-inflammatory diseases including ulcerative colitis, Crohn’s Disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.
In a Phase 2, randomized, placebo-controlled, dose-ranging study (OASIS) in moderate to severe UC patients, most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46, with etrasimod 2 mg in the open-label extension. Etrasimod also demonstrated a favorable benefit/risk profile, consistent with safety findings reported in the double-blind portion of OASIS.
About ELEVATE UC 52
ELEVATE UC 52 is one of two pivotal trials that are part of the ELEVATE UC global Phase 3 registrational program. ELEVATE UC 52 is a 2:1 randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of etrasimod 2 mg once-daily in participants with moderately-to-severely active UC. This is a one-year trial evaluating clinical remission at 12 weeks, or induction, and at 52 weeks. ELEVATE UC 52 utilized a treat-through design in which patients were eligible to continue with etrasimod independent of whether they reached clinical response at week 12.
About Ulcerative Colitis
UC is a chronic and often debilitating inflammatory bowel disease1 that affects many people worldwide, including an estimated 3.8 million people in North America and Europe.2 Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss.3,4 UC can have a significant effect on work, family and social activities.4
About Pfizer Inflammation & Immunology
At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients living with immuno-inflammatory diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.
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