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Find Clinical Drug Pipeline Developments & Deals by Apellis Pharmaceuticals

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Nephrology Product Name: APL-2

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 05, 2020

            Details:

            Apellis is advancing a registrational program in C3G / IC-MPGN beginning with the Phase 2 NOBLE study, a randomized, controlled trial in 12 patients with post-transplant disease recurrence that will focus on the histopathology of the kidneys.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Ophthalmology Product Name: APL-2

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            This new analysis of the FILLY study demonstrates that pegcetacoplan impacts the progression of nascent GA,1,2 the earlier stage of disease that precedes atrophy, in areas of the retina outside of GA lesions.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: APL-2

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 15, 2020

            Details:

            The NDA and MAA submissions are based on results from the Phase 3 PEGASUS study, which met its primary endpoint, demonstrating the superiority of pegcetacoplan to eculizumab with a statistically significant improvement in hemoglobin levels at 16 weeks.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Ophthalmology Product Name: APL-2

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            A total of 1,259 patients are enrolled in DERBY and OAKS, which are pivotal randomized Phase 3 studies designed to compare the efficacy and safety of intravitreal pegcetacoplan with sham treatment in patients with GA secondary to AMD.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: APL-2

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 02, 2020

            Details:

            The study was designed to evaluate the efficacy of pegcetacoplan in 48 adult patients who are treatment-naïve, showed evidence of hemolysis (elevated LDH ≥ 1.5x ULN) and had hemoglobin levels that were less than the lower limit of normal at the time of their screening.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 12, 2020

            Details:

            71% of pegcetacoplan-treated patients achieved LDH normalization vs. 15% of eculizumab-treated patients. Detailed results from positive head-to-head Phase 3 PEGASUS study in patients with paroxysmal nocturnal hemoglobinuria presented at the European Hematology Association.

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            Lead Product(s): APL-9

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 28, 2020

            Details:

            Company has initiated a Phase 1/2 clinical study of APL-9, an investigational C3 inhibitor designed for acute interventions, in COVID-19 patients with respiratory failure including acute respiratory distress syndrome (ARDS).

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 21, 2020

            Details:

            The NDA submission is backed by results from Apellis Phase 3 PEGASUS study. Based on feedback from the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting to discuss the registration strategy for pegcetacoplan.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 28, 2020

            Details:

            The analysis of APL2-103 has shown that the Phase 3 formulation was well tolerated over 12 months of treatment.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 07, 2020

            Details:

            In a head-to-head phase 3 trial after 16 weeks, hemoglobin levels in the pegcetacoplan arm had increased by 3.8 g/dL over the Soliris group, resulting in the trial hitting its primary endpoint.