Dec 3, 2024, 11:20 PM
Dec 3, 2024, 11:20 PM

Everest Medicines achieves positive clinical trial results for EVER001

Highlights
  • Everest Medicines conducted a Phase 1b/2a clinical trial of EVER001 in China to evaluate its effectiveness in treating Primary Membranous Nephropathy.
  • Preliminary results showed that in the low-dose cohort, 81.8% achieved overall clinical remission, while in the high-dose cohort, 85.7% achieved overall clinical remission.
  • The positive results position EVER001 as a promising treatment option for autoimmune renal diseases.
Story

On December 4, 2024, Everest Medicines shared positive preliminary results from a Phase 1b/2a clinical trial of EVER001, a novel Bruton's tyrosine kinase (BTK) inhibitor intended for treating Primary Membranous Nephropathy (pMN). The clinical trial, taking place in China and approved by the Center for Drug Evaluation of the National Medical Products Administration in September 2022, aimed to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in patients presenting with glomerular diseases characterized by proteinuria. The results indicated significant efficacy in both the low-dose and high-dose cohorts of patients. In the low-dose group, out of 11 patients who completed 36 weeks of treatment, 9 patients (81.8%) achieved overall clinical remission, while 10 patients (91%) achieved immunological complete remission. In the high-dose group, 6 out of 7 patients (85.7%) reached overall clinical remission, and all patients achieved immunological complete remission by week 24. These findings support the potential of EVER001 as a leading option in the treatment landscape for autoimmune renal diseases. The importance of this trial is amplified considering the estimated 2 million individuals affected by pMN in China, along with significant patient populations in the United States, Europe, and Japan. The data were disclosed publicly in a move that marks the first time Everest Medicines has shared results from its global pipeline, emphasizing their commitment to developing innovative treatments for unmet medical needs. The results build on findings from a preliminary completed phase 1 trial conducted with healthy subjects by SinoMab in China, which demonstrated favorable pharmacokinetic properties and a strong safety profile for EVER001. The announcement comes at a crucial moment for patients suffering from autoimmune renal diseases, as effective treatment options have been limited. With the results of this trial, Everest Medicines is poised to advance the development of EVER001, aiming to bring it to market as a next-generation BTK inhibitor that could significantly improve treatment options for pMN and potentially other autoimmune conditions characterized by B-cell activation. The successful completion of the trial addresses an urgent need within the medical community and provides hope for many patients and their families seeking more effective disease management options.

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