Everest Medicines' Licensing Partner Pfizer Announces U.S. FDA Approves Etrasimod for Adults with Moderately to Severely Active Ulcerative Colitis

Rhea-AI Summary

Everest Medicines announces FDA approval for VELSIPITY™ (etrasimod) for ulcerative colitis

Positive

• FDA approves VELSIPITY™ (etrasimod) for ulcerative colitis, a significant milestone for patients in need of new treatments.
• VELSIPITY™ provides a once-daily pill option for moderately to severely active UC patients with a favorable benefit-risk profile.

Negative

• None.

SHANGHAI, Oct. 15, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK) announced today that its licensing partner, Pfizer Inc. (NYSE: PFE) has received approval from the U.S. Food and Drug Administration (FDA) for VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). Importantly, VELSIPITY™'s label does not include the "titration is required for treatment initiation" language found in other S1P modulator's label. Everest is conducting a multi-center Phase 3 clinical trial of etrasimod in Asia and aims to file New Drug Application as soon as possible.

"We congratulate our partner for achieving this significant milestone for UC patients who are in urgent need of new and effective treatment options, and prefer the convenience of a once-daily pill. Etrasimod is a proven advanced treatment with a favorable safety profile." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Everest will advance our late-stage study as quickly as possible towards registration in China and other Asian markets as the incidence of ulcerative colitis has been rapidly increasing in the region in recent years."

"Etrasimod's FDA approval marks an important milestone for moderately to severely active UC patients who need new treatments for this chronic condition. Etrasimod provides those patients with the treatment option of an oral, once-daily pill that has a favorable benefit-risk profile," said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod's clinical trial in Asia. "The Asia Phase 3 clinical trial has completed patient enrollment and we look forward to having etrasimod available in China and other Asian countries to benefit more patients."

The number of UC patients in China is expected to more than double from 2019 to reach approximately one million by 2030, highlighting the need for novel treatments for the disease. Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer in 2022. Everest Medicines obtained exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017.

The U.S. FDA approval was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.0% for patients receiving placebo at week 12 (20.0% differential, P˂.001) and was 32.0% compared to 7.0% at week 52 (26.0% differential, P=˂.001). In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving etrasimod compared to 15.0% of patients receiving placebo (11.0% differential, P=<.05). All key secondary efficacy endpoints were met at week 12, including endoscopic improvement and mucosal healing. The safety of etrasimod was consistent with previous studies, with the most common adverse reactions being headache, elevated liver tests, and dizziness (incidence ≥ 5%).

About Etrasimod

Etrasimod is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory applications for VELSIPITY in ulcerative colitis have been submitted to countries around the world for review, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for etrasimod, with a decision anticipated in the beginning of 2024.

About ELEVATE UC 52 and ELEVATE UC 12

ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials that are part of the ELEVATE UC Phase 3 registrational program.

ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial that utilized a treatthrough design comprising of a 12-week induction period followed by a 40-week maintenance period. Subjects were randomized to VELSIPITY or placebo and continued on treatment without re-randomization for the entire duration of the study. Beginning at week 12, all patients could continue their randomized treatment; patients whose disease had not improved or had worsened compared to baseline could discontinue and, if eligible, enroll in an open-label extension study. The primary objective of this trial was to assess the safety and efficacy of etrasimod 2 mg once daily on clinical remission after both 12 and 52 weeks. The primary endpoint is based on the 3-domain, modified Mayo score (MMS). In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.0% for patients receiving placebo at week 12 (20.0% differential, P˂.001) and was 32.0% compared to 7.0% at week 52 (26.0% differential, P˂.001). Statistically significant improvements were attained in all key secondary endpoints, including endoscopic improvement and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52.

ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of etrasimod 2 mg once-daily in subjects with moderately-to-severely active UC. The primary objective of this trial was to assess the safety and efficacy of etrasimod on clinical remission at 12 weeks assessed by the FDA-required, 3-domain, MMS. In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving etrasimod compared to 15.0% of patients receiving placebo (11.0% differential, P <.05). All key secondary endpoints were met at week 12, including endoscopic improvement and mucosal healing.

In ELEVATE UC 12, a similar proportion of patients experienced treatment-emergent adverse events (AEs) between etrasimod 2 mg and placebo treatment groups, while in ELEVATE UC 3 52, it was higher in the etrasimod 2 mg group compared to placebo. The proportion of patients experiencing serious AEs was similar between treatment groups in both trials. The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache, elevated liver tests, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. Data support that initiation of etrasimod treatment does not require a complex up-titration regimen.

Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, were naïve to biologic or JAK inhibitor therapy.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include cardio-renal diseases, autoimmune disorders, and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

View original content:https://www.prnewswire.com/news-releases/everest-medicines-licensing-partner-pfizer-announces-us-fda-approves-etrasimod-for-adults-with-moderately-to-severely-active-ulcerative-colitis-301956907.html

SOURCE Everest Medicines

FAQ

What is the FDA approval for?

The FDA has approved VELSIPITY™ (etrasimod) for adults with moderately to severely active ulcerative colitis.

Who is Everest Medicines' licensing partner?

Everest Medicines' licensing partner is Pfizer Inc.

What is the incidence of ulcerative colitis in Asia?

The incidence of ulcerative colitis has been rapidly increasing in Asia in recent years.

What were the results of the Phase 3 clinical trial for etrasimod?

The Phase 3 clinical trial showed that etrasimod achieved clinical remission in UC patients, with a favorable safety profile.

What are the common adverse reactions to etrasimod?

The most common adverse reactions to etrasimod are headache, elevated liver tests, and dizziness.