Apellis Pharmaceuticals Announces Poster Presentations at the American Society of Hematology Annual Meeting
November 1, 2018
One abstract provides updates on PADDOCK, a Phase 1b open-label, dose-escalation trial designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple doses of APL-2, administered by daily subcutaneous injection (SC), in patients with paroxysmal nocturnal hemoglobinuria (PNH). The second abstract provides updates on PLAUDIT, a Phase 2, open-label trial assessing the safety, tolerability, efficacy, and PK of multiple subcutaneous (SC) doses of APL-2 administered daily in patients with autoimmune hemolytic anemia (AIHA), including warm autoimmune hemolytic anemia (wAIHA) and cold agglutinin disease (CAD).
Poster Presentation 1: Inhibition of C3 with APL-2 Results in Normalization of Markers of Intravascular and Extravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster II
Poster Presentation 2: Inhibition of C3 with APL-2 Results in Normalization of Markers of Intravascular and Extravascular Hemolysis in Patients with Autoimmune Hemolytic Anemia (AIHA)
Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
In accordance with ASH policies, abstracts submitted to the ASH Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the ASH Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the ASH Annual Meeting.
APL-2 is designed to inhibit the complement cascade centrally at C3 and may have the potential to treat a wide range of complement-mediated diseases more effectively than is possible with partial inhibitors of complement. APL-2 is a synthetic cyclic peptide conjugated to a polyethylene glycol (PEG) polymer that binds specifically to C3 and C3b, effectively blocking all three pathways of complement activation (classical, lectin, and alternative).
Apellis is currently evaluating APL-2 in two Phase 1b trials (PHAROAH and PADDOCK) for systemic administration in paroxysmal nocturnal hemoglobinuria. Previously reported interim data from these trials showed improvements in lactate dehydrogenase and hemoglobin levels in patients who are suboptimal responders to eculizumab and untreated patients, respectively. Apellis is also testing APL-2 for systemic administration in a Phase 2 clinical trial in autoimmune hemolytic anemia (AIHA) and a Phase 2 clinical trial in complement dependent nephropathies, as well as a Phase 3 trial for patients with PNH.
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 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, 2018 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.
Source: Apellis Pharmaceuticals, Inc.