Apellis Pharmaceuticals Announces VALIANT Study Presentation Details
WALTHAM, Mass. — Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) has shared exciting news about their Phase 3 VALIANT study of pegcetacoplan, a potential treatment for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study's abstract will be presented at the prestigious American Society of Nephrology (ASN) Kidney Week, held from October 23 to 27.
Webinar Announcement
Following this significant presentation, Apellis will host a webinar to dive deeper into the VALIANT results. The live session is scheduled for October 26 at 12:30 p.m. PT, making it a prime opportunity for healthcare professionals and stakeholders to engage with the findings directly from the company’s leading experts.
High Impact Clinical Trials Oral Presentation Details
The presentation highlights the rigorous work underlying the VALIANT study. Dr. Carla Nester, M.D., MSA, FASN, is set to lead this oral presentation titled:
“VALIANT: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Trial of Pegcetacoplan for Patients with Native or Post-transplant Recurrent Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN).” This session is slated for Saturday, October 26, at 11:00 a.m. PT in Hall D of the convention center.
Additional Poster Presentations
In addition to the oral presentation, Apellis has two abstracts accepted for poster presentations during Kidney Week. These posters will showcase:
“Pegcetacoplan for Post-transplant Recurrent C3 Glomerulopathy (C3G) or Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) in NOBLE: 52-Week Patient Evolution” by Dr. Anuja Java, M.D. and “Long-Term Safety and Efficacy of Pegcetacoplan in Patients with C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis: The Long-Term VALE Extension Study” by Dr. Carla Nester, M.D., MSA, FASN. Both of these presentations are scheduled for Saturday, October 26, at 10:00 a.m. PT in the exhibition hall.
In-Depth on the VALIANT Study
The VALIANT Phase 3 study evaluates pegcetacoplan's efficacy and safety for C3G and IC-MPGN. It stands as the largest single trial conducted for these patient populations, analyzing data from 124 individuals aged 12 and older. Participants received either pegcetacoplan or a placebo twice weekly over a 26-week timeframe, after which they transitioned into an open-label phase receiving the treatment. The primary endpoint focuses on the urine protein-to-creatinine ratio to assess treatment efficacy.
Understanding C3 Glomerulopathy and IC-MPGN
C3G and IC-MPGN are complex kidney disorders often leading to kidney failure, with a survival rate post-diagnosis revealing that around half of patients may experience kidney failure within five to ten years. The recurrence rate in individuals post-transplant is significantly high, which stresses the urgent need for effective treatments targeting the underlying causes.
Pegcetacoplan's Role in Rare Kidney Diseases
Pegcetacoplan operates as a targeted therapy that aims to control the over-activation of the complement cascade, which is linked to various serious conditions. Notably, this medication is also approved for treating paroxysmal nocturnal hemoglobinuria (PNH) as EMPAVELI/Aspaveli in numerous regions, thus highlighting its broader therapeutic impact in rare disease management.
About Apellis Pharmaceuticals
Apellis Pharmaceuticals, Inc. is dedicated to blending innovative science with empathetic care in the development of transformative therapies. With two approved treatments targeting C3, including a groundbreaking option for geographic atrophy, Apellis is poised to expand its frontiers in addressing serious conditions across multiple medical landscapes.
For media inquiries, reach out to:
Media Contact:
Tracy Vineis
media@apellis.com
617.420.4839
Investor Contact:
Meredith Kaya
meredith.kaya@apellis.com
617.599.8178
Frequently Asked Questions
What is the VALIANT study about?
The VALIANT study investigates the efficacy and safety of pegcetacoplan for treating C3 glomerulopathy and IC-MPGN.
When will the VALIANT study results be presented?
The results will be presented at the ASN Kidney Week on October 26 at 11:00 a.m. PT.
How can I participate in the webinar?
The webinar discussing the VALIANT study results is scheduled for October 26 at 12:30 p.m. PT.
What are C3G and IC-MPGN?
C3G and IC-MPGN are rare kidney diseases that can lead to kidney failure and currently have no targeted therapies.
What role does pegcetacoplan play in treating these conditions?
Pegcetacoplan targets the complement system, which is believed to play a role in the progression of C3G and IC-MPGN, providing a potentially effective treatment option.
