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Company also provides an update on plans in nephrology
CRESTWOOD, Ky. and WALTHAM Mass., Oct. 11, 2019 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals Inc. (Nasdaq: APLS), a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced that preliminary clinical data evaluating APL-2 (pegcetacoplan) in complement 3 glomerulopathy (C3G) will be presented at the American Society of Nephrology (ASN) Kidney Week 2019 in Washington D.C. from Nov. 5 - 10.
Data from eight patients in the C3G cohort of the Phase 2 DISCOVERY trial of APL-2 will be presented through study day 84 (12 weeks). The DISCOVERY trial is an open-label trial investigating the safety and biological activity of APL-2 in four renal diseases: C3G, immunoglobulin A (IgA) nephropathy, primary membranous nephropathy, and lupus nephritis.
“We remain focused on advancing clinical development in diseases where we believe APL-2 has the greatest potential to make a transformative difference,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “With this approach in mind, we decided early on in this study to focus on C3G, a rare disease with significant unmet need that is characterized by uncontrolled activation of C3.
“Approximately 30-50% of people with C3G progress to kidney failure within 10 years of diagnosis, and there are no therapies currently approved for people with this disease. We are excited to present at Kidney Week as it is the first time that data on APL-2 in C3G will be shared, and we look forward to meeting with regulators in the coming months to discuss future development plans in C3G.”
In C3G, a part of the immune system known as the complement cascade is abnormally active, which results in the excessive breakdown of a protein called C3. Those C3 breakdown products become trapped in the kidney, causing inflammation and damage to the organ. APL-2, an investigational therapy that targets C3, may have the potential to address the underlying cause of the disease.
The details for the two poster presentations are:
Nephrology Program Update
The DISCOVERY trial (NCT03453619) aimed to enroll 6-12 patients per disease, and the primary endpoint is change from baseline in proteinuria at week 48. The DISCOVERY trial has completed enrollment with the following patients: C3G (n=8), IgA nephropathy (n=6), primary membranous nephropathy (n=5), and lupus nephritis (n=2). While Apellis intends to advance clinical development in C3G, the company does not currently plan additional clinical development in primary membranous nephropathy or lupus nephritis, following the completion of the DISCOVERY trial in 2020. Further clinical development in subgroups of patients with IgA nephropathy is under evaluation.
About APL-2 (pegcetacoplan)
APL-2, an investigational drug, is designed to inhibit the complement cascade at C3 and may have the potential to treat a wide range of complement-mediated diseases. APL-2 is a synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer that binds specifically to C3 and C3b. Apellis is currently evaluating APL-2 in Phase 3 trials in patients with paroxysmal nocturnal hemoglobinuria (PNH) and geographic atrophy (GA), and has announced plans to advance into a Phase 3 trial in patients with cold agglutinin disease. For additional information regarding our clinical trials, visit www.apellis.com/clinical-trials.html.
Apellis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds for the treatment of a broad range of life-threatening or debilitating autoimmune diseases based upon complement immunotherapy through the inhibition of the complement system at the level of C3. Apellis is the first company to advance chronic therapy with a C3 inhibitor into clinical trials. For additional information about Apellis and APL-2, please visit http://www.apellis.com.
Apellis Forward-Looking Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the implications of preliminary clinical data. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials such as the results reported in this release will be indicative of results that will be generated in future clinical trials; whether APL-2 will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of such clinical trials will warrant regulatory submissions and whether APL-2 will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies for GA, PNH, C3G or any other indication; whether, if Apellis’ products receive approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Apellis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on July 31, 2019 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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