August 17, 2017 7:54 AM ET

Biotechnology

Company Overview of Apellis Pharmaceuticals, Inc.

Company Overview

Apellis Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery and development of therapeutic compounds for autoimmune and inflammatory diseases. Its lead product candidates include APL-2 and APL-1, to treat paroxysmal nocturnal hemoglobinuria, geographic atrophy, intermediate age-related macular degeneration, and chronic obstructive pulmonary disease. The company develops APL-2 for subcutaneous injection, which is an injection into the tissue under the skin, and for intravitreal injection that is an injection into the eye, as well as APL-1 for inhaled administration. Apellis Pharmaceuticals, Inc. was founded in 2009 and is based in Crestwood, Kentucky.

6400 Westwind Way

Suite A

Crestwood, KY 40014

United States

Founded in 2009

11 Employees

Phone:

502-241-4114

Fax:

502-241-4116

Key Executives for Apellis Pharmaceuticals, Inc.

Co-Founder, Chief Executive Officer, President and Director
Age: 45
Co-Founder and Chief Operating Officer
Age: 47
Co-Founder and Vice-President of Clinical Development
Age: 43
Co-Founder and Director
Age: 44
Interim Chief Financial Officer
Age: 60
Compensation as of Fiscal Year 2017.

Apellis Pharmaceuticals, Inc. Key Developments

Apellis Pharmaceuticals, Inc. Announces Update on Phase Ib Paroxysmal Nocturnal Hemoglobinuria Trial

Apellis Pharmaceuticals, Inc. has provided an update on clinical outcomes in its two ongoing Phase Ib clinical trials with APL-2, a complement C3 inhibitor, in the treatment of patients with paroxysmal nocturnal hemoglobinuria. Apellis is developing APL-2 as a next generation monotherapy, with the goal of resolving anemia and transfusion dependency in PNH patients on standard of care. APL-2 is being developed for newly diagnosed PNH patients as well as for patients who suffer from anemia while receiving standard of care intravenous infusions of eculizumab. Eculizumab is a complement C5 inhibitor that improves anemia in patients with PNH, but leaves up to 75% of PNH patients anemic and 35-40% transfusion-dependent. APL-2 is being evaluated in two Phase Ib clinical trials. PADDOCK is an open label safety and efficacy study of 270mg of APL-2 administered daily by subcutaneous injection to PNH patients (n=3) who have never received eculizumab. In PADDOCK, in the first month, all three patients treated with APL-2 monotherapy experienced rapid corrections in lactate dehydrogenase (LDH), a key marker of hemolytic activity in PNH, from an average of 1,615 U/L to an average of 275 U/L (1.1x upper limit of normal), a decline of 83%. PHAROAH is an open label safety and efficacy study of 270mg of APL-2 administered daily by subcutaneous injection as a complementary therapy to suboptimal responders to eculizumab (n=6), defined as hemoglobin levels (Hb) of less than 10 g/dL at screening or a history of at least one transfusion in the previous year. In the first month, average Hb levels in the six patients increased from 8.8 g/dL to 11.9 g/dL, an increase of 36%. During this period, patients also experienced rapid corrections in LDH from an average of 280 U/L (1.3x upper limit of normal) to an average of 163 U/L (0.8x upper limit of normal), a decline of 42%. After six months, the average Hb level was 11.4 g/dL, and the average LDH level continued to be normal at 184 U/L (0.9x upper limit of normal). During that same period, the average transfusion rate dropped from 3.4/month on eculizumab monotherapy to 0.3/month when APL- 2 was added to eculizumab. Notably, five of six patients on baseline were receiving higher than normal dosing with eculizumab in the form of 1,200 mg every two weeks or 900 mg every week, as opposed to the normal 900 mg every two weeks. There have been no significant drug-related safety concerns and overall APL-2 was well tolerated in both PADDOCK and PHAROAH during the six months of dosing. None of the patients experienced episodes of breakthrough hemolysis, which can occur in patients treated with C5 inhibitors.

Apellis Pharmaceuticals, Inc. Announces FDA Fast Track Designation for APL-2 in PNH

Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for APL-2, a complement C3 inhibitor, in the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), who continue to experience hemolysis and require RBC transfusions despite receiving therapy with eculizumab. PNH is a rare, acquired, potentially life-threatening disease characterized by complement-mediated hemolytic anemia. Fast track is a program designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track designation offers various benefits, including more frequent meetings with FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and Rolling Review, which allows the company to submit completed sections of its New Drug Application (NDA), rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

Apellis Pharmaceuticals, Inc. Presents at NY/NJ CEO Conference, Nov-02-2016 01:30 PM

Apellis Pharmaceuticals, Inc. Presents at NY/NJ CEO Conference, Nov-02-2016 01:30 PM. Venue: Apella at Alexandria Center, 450 E. 29 Street, New York, NY 10016, United States. Speakers: Cedric Francois, Co-Founder, Chief Executive Officer, President and Director.

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