Pfizer, Lilly, and Janssen Report Positive Clinical Trial Results in Inflammatory Bowel Disease at DDW 2022

Compiled by Dine

From May 21 to May 24, the Digestive Disease Week (DDW) 2022 was held in San Diego, USA, in a combined online and offline format, comprehensively presenting the current state of global gastroenterology research. During the event, several pharmaceutical companies, including Pfizer, Eli Lilly, and Johnson & Johnson, announced updates on their investigational therapies for various digestive diseases.

01Pfizer

Pfizer Announces Results from Two Pivotal Trials, Including the ELEVATE UC Phase III Registration Program, Evaluating Etrasimod, a Selective Sphingosine 1-Phosphate (S1P) Receptor Modulator, for Moderate to Severe Active Ulcerative Colitis. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P) receptor modulator currently under investigation for multiple indications, including UC, atopic dermatitis, Crohn’s disease, alopecia areata, and eosinophilic esophagitis.

In the 52-week ELEVATE UC 52 study, the clinical remission rate at week 12 was 27% for patients taking etrasimod compared to 7.4% for the placebo group, while the clinical remission rate was 32.1% at week 52 versus 6.7%. In the second trial, ELEVATE UC 12, the clinical remission rate was 24.8% for patients receiving etrasimod and 15.2% for those receiving placebo.

It is worth mentioning that Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer in March 2022.

02Eli Lilly and Company

At the conference, Eli Lilly announced positive results from a Phase 3 clinical trial of its monoclonal antibody mirikizumab, which targets the p19 subunit of IL-23. Compared to patients receiving a placebo, those treated with the drug maintained significant improvements after one year. The study met its primary endpoint of clinical remission and all key secondary endpoints, including the severity of bowel urgency.

Specifically, among patients who responded to 12 weeks of mirikizumab induction therapy, 49.9% reported clinical remission after one year, compared to only 25.1% in the placebo group. Among those who achieved remission at week 12, approximately 63.6% maintained this status after one year, versus 36.9% for those on placebo. Interestingly, up to 97.8% of patients taking mirikizumab and achieving clinical remission after one year had been steroid-free for at least three months prior to the end of the maintenance treatment period.

In addition, in the first quarter of 2022, Eli Lilly submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) and a marketing authorization application for mirikizumab for UC to the European Union. Regulatory agencies are expected to make a decision in 2023.

03Janssen

Janssen Pharmaceuticals, a Johnson & Johnson company, announced new data from the Phase 1 GALAXI trial of TREMFYA® (guselkumab) in adult patients with moderate to severe active Crohn's disease (CD), as well as three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STLARA® (ustekinumab).

GALAXI 1 data show that study participants who had an inadequate response or were intolerant to conventional therapies and/or biologics treated with TREMFYA achieved high levels of clinical biomarker response a (47.5-66.7%), endoscopic response b (44.3-46%), and clinical remission with C-reactive protein (CRP) ≤3 mg/L or fecal calprotectin ≤250 μg/g (39.3-66.7%) across dose groups at week 48.

TREMFYA is not approved in the United States for the treatment of adult patients with CD or UC. A pooled analysis of long-term safety data for STLARA-treated biologic-naïve and biologic-failure CD/UC patients demonstrated a favorable safety profile, consistent with the analysis of the overall inflammatory bowel disease (IBD) population and the approved safety profile for the indication.

In addition, a pooled safety analysis of STELARA across 13 studies for all approved indications (including data from up to one year in psoriatic arthritis [PsA], 2 UC studies, 5 CD studies, and plaque psoriasis [PsO]) showed no increased rate of malignancy (adjusted for follow-up time) with STELARA treatment compared to placebo.

Reference Source:

1.Pfizer and Lilly Zero in on Success in Ulcerative Colitis

2.Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA (guselkumab) and Long-Term Safety Profile for STELARA (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week 2022

3.After COVID and new global disruptions, Eli Lilly does victory lap with UC data