Everest Medicines' Partner Calliditas Therapeutics Announces Full Results From NefIgArd Phase 3 Trial published in The Lancet

Rhea-AI Summary

Everest Medicines' partner, Calliditas Therapeutics, announced the publication of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN). The trial met its primary endpoint, showing significant kidney protective effects of Nefecon® over placebo. Nefecon® demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over a two-year period. The reduction in urine protein-to-creatinine ratio (UPCR) observed with Nefecon® treatment was durable, reflecting a long-lasting treatment effect during the follow-up period. Nefecon® was generally well tolerated with mild or moderate adverse events.

Positive

• The NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN) met its primary endpoint, showing significant kidney protective effects over placebo.
• Nefecon® demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over a two-year period.
• The reduction in urine protein-to-creatinine ratio (UPCR) observed with Nefecon® treatment was durable, reflecting a long-lasting treatment effect during the follow-up period.
• Nefecon® was generally well tolerated with the majority of adverse events being mild or moderate.
• Nefecon® has been approved and marketed in the United States, European Union, and the UK under different brand names.

Negative

• None.

SHANGHAI, Aug. 17, 2023 /PRNewswire/ -- Everest Medicines' (HKEX 1952.HK, "Everest", or the "Company") partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced the publication in The Lancet of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN). The Phase 3 trial met its primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon® demonstrating significant kidney protective effect over placebo.

"The publication of the NefIgArd Phase 3 trial data in The Lancet highlights the significance of these data, and the efficacy of Nefecon® as a first-in-disease therapy for IgAN patients. The established long-term eGFR benefit reflects Nefecon®'s ability to slow kidney function decline by targeting the origin of the disease and providing a differentiated and disease-modifying treatment alternative," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Everest participated in the NefIgArd study, and plans to publish the Chinese subpopulation data in a future medical conference. We look forward to bringing Nefecon® to Chinese patients as we await the review of our New Drug Application in the second half of this year."

"The data demonstrated supportive 2-year total slope analyses that were not only statistically significant but also clinically meaningful, showcasing a sustained treatment benefit. The eGFR benefit was observed across the entire study population, irrespective of baseline urine protein-to-creatinine ratio (UPCR)," said Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare and lead author of the publication. "The sustained reduction of proteinuria and the protective effect on kidney function support the disease-modifying effect of Nefecon. These robust results provide new hope for patients and reinforce Nefecon's potential to make a meaningful difference in the lives of those affected by this challenging disease."

The analysis published in The Lancet shows that Nefecon® demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in eGFR over the two-year period of 9-months of treatment with Nefecon® and 15-months of follow-up off drug. After the two-year period, there was a 6.11 mL/min/1.73 m² decline in eGFR in the Nefecon® arm compared with a 12.0 mL/min/1.73 m² decline in the placebo arm, corresponding to a difference in two-year eGFR total slope of 2.95 mL/min/1.73m² per year (p<0·0001).

The reduction in UPCR observed with Nefecon® treatment was durable, reflecting a long-lasting treatment effect during the 15-month follow-up period off treatment. Patients treated with Nefecon® maintained a greater than 30% proteinuria reduction from the end of the 9-month treatment through the entire follow-up period, with a reduction in UPCR of over 50% observed at 12 months.

Nefecon® was generally well tolerated, with the majority of treatment-emergent adverse events (TEAE) being mild or moderate, and with TEAEs leading to discontinuation of study drug in <10% of patients. Objective measures of mean weight and blood pressure showed non-clinically relevant changes.

Nefecon® has been approved and marketed in the United States under the brand name TARPEYO®, and under the brand name Kinpeygo® in the European Union and the UK under accelerated and conditional approval, respectively. The China National Medical Products Administration (NMPA) accepted Everest's NDA for Nefecon® for the treatment of IgAN in November 2022 with priority review.

About Nefecon®

Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.

Nefecon® was approved in the United States under accelerated approval based on a reduction in proteinuria. Recently announced topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd demonstrated a statistically significant benefit for Nefecon® over placebo in estimated glomerular filtration rate (eGFR), a measure of renal function.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 discovery, 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 renal diseases, infectious diseases, mRNA platform and autoimmune disorders. 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.

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SOURCE Everest Medicines

FAQ

What is the company name associated with the press release?

The company associated with the press release is Everest Medicines.

What is the primary endpoint that the NeflgArd Phase 3 trial met?

The NeflgArd Phase 3 trial met its primary endpoint of showing significant kidney protective effects of Nefecon® over placebo.

What were the results of Nefecon® compared to placebo in terms of estimated glomerular filtration rate (eGFR)?

Nefecon® demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in eGFR over a two-year period.

What was the observed effect of Nefecon® treatment on urine protein-to-creatinine ratio (UPCR)?

The reduction in UPCR observed with Nefecon® treatment was durable, reflecting a long-lasting treatment effect during the follow-up period.

How was the tolerability of Nefecon®?

Nefecon® was generally well tolerated with the majority of adverse events being mild or moderate.

In which regions has Nefecon® been approved and marketed?

Nefecon® has been approved and marketed in the United States, European Union, and the UK under different brand names.