Everest Medicines Licensing Partner Pfizer Announces FDA and EMA Acceptance of Regulatory Submissions for Etrasimod for Ulcerative Colitis

CARRY OFF, December 21, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK) today announced that its licensing partner, Pfizer Inc. (NYSE: PFE) has received acceptance from the US Food and Drug Administration (FDA) to review a New Drug Application (NDA) for etrasimod for people living with moderately to severely active ulcerative colitis (UC). The FDA decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision expected in the first half of 2023. 2024. The FDA approval will be the first approval of etrasimod globally.

“We congratulate our partner for making significant regulatory advances to lead etrasimod as a potential best-in-class therapy for patients with ulcerative colitis,” said Rogers Yongqing Luo, CEO of Everest Medicines. “Our goal is to complete patient enrollment for our Phase 3 study in Asia in the first half of 2023 and, if approved, we hope to bring this novel treatment to the Asian population as soon as possible.”

Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer earlier this year. Everest Medicines obtained exclusive rights from Arena to develop, manufacture and market etrasimod in biggest china Y South Korea in 2017. The incidence of UC is continuously increasing in Porcelain in the last decades. The number of patients with UC in Porcelain it is expected to more than double from 2019 to reach more than 900,000 by 2030, highlighting significant unmet demand for novel treatments for the disease. According to the Frost & Sullivan report, the size of the UC market was 3.4 billion RMB in 2019 in Porcelain and it is estimated that it will expand to 8.1 billion RMB by 2024, representing a compound annual growth rate of 18.9%.

Pfizer’s NDA submissions were based on previously announced results from the ELEVATE UC Phase 3 registration program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once daily in clinical remission in patients with UC who had previously failed or were intolerant of at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Both randomized, double-blind, placebo-controlled studies achieved all key primary and secondary endpoints, with a safety profile consistent with previous studies. In the ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P≤0.001 ) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P≤.001). In ELEVATE UC 12, clinical remission was achieved in 24.8% of patients receiving etrasimod compared with 15.2% of patients receiving placebo (9.7% differential, p=0.0264) .

About Etrasimod

Etrasimod is an oral, once daily, selective sphingosine 1-phosphate (S1P) receptor modulator designed to optimize the pharmacology and engagement of S1P 1, 4, and 5 receptors. In addition to UC, it is being investigated for a variety of other immunoinflammatory diseases.

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 registration program.

ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial that used a continuous treatment design comprising a 12-week lead-in period followed by a 40-week maintenance period. As of week 12, all patients could continue with their randomized treatment; patients whose disease had not improved or worsened compared to baseline could discontinue and, if eligible, enroll in an open-label extension study. The primary objective of this trial was to evaluate the safety and efficacy of etrasimod 2 mg once daily in clinical remission after 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 7.4% for patients receiving placebo at week 12 (19.8% difference, P≤0.001) and was 32.1% compared to 6.7% at week 52 (25.4% difference, P≤.001). Statistically significant improvements were achieved in all key secondary endpoints, including endoscopic improvement, symptomatic remission 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 evaluate 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 evaluate the safety and efficacy of etrasimod in clinical remission at 12 weeks as assessed by the FDA-required 3-domain MMS. In ELEVATE UC 12, clinical remission was achieved in 24.8% of patients receiving etrasimod compared with 15.2% of patients receiving placebo (9.7% differential, p=0.0264) . All key secondary endpoints were met at week 12, including endoscopic improvement, symptomatic remission, and mucosal healing.

In ELEVATE UC 12, a similar proportion of patients experienced treatment-emergent adverse events (AEs) between the etrasimod 2 mg and placebo treatment groups, whereas in ELEVATE UC 52, it was higher in the etrasimod 2 mg group compared with placebo. the placebo group. The proportion of patients experiencing serious adverse events 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 any of the trials were headache, UC worsening, COVID-19 infection, dizziness , pyrexia, arthralgia, abdominal pain and nausea. There were no reports of bradycardia or atrioventricular block as serious adverse events. Data supporting initiation of treatment with etrasimod do not require a complex dose escalation regimen.

Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, had not received JAK inhibitor or biologic therapy.

About Everest Medications

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceuticals that address the unmet critical medical needs of patients in Asian markets. Everest Medicines’ management team has a wealth of experience and extensive track records from both major 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 best-in-class or first-in-class molecules, many of which are in advanced stages of clinical development. The Company’s therapeutic areas of interest include cardiorenal diseases, autoimmune disorders and infectious diseases. For more information, visit their website at www.everestmedicines.com.

Forward-Looking Statements:

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SOURCE Everest Pharmaceuticals

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