Apellis' (APLS) PNH Drug Betters Alexion's Soliris In Study
Zacks Investment Research | Jan 08, 2020 07:48AM ET
Apellis Pharmaceuticals, Inc.’s (NASDAQ:APLS) investigational therapy pegcetacoplan met the primary efficacy endpoint in a phase III head-to-head study, comparing it to Alexion’s (NASDAQ:ALXN) Soliris (eculizumab) in patients with paroxysmal nocturnal hemoglobinuria (PNH).
A rare blood disorder, PNH is associated with abnormally low hemoglobin levels as the disease destroys red blood cells. Top-line data from the PEGASUS study showed that patients treated with pegcetacoplan experienced a bigger increase in hemoglobin levels than those taking Soliris.
Pegcetacoplan demonstrated an improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16, versus a 1.5 g/dL decrease in the Soliris arm, thereby meeting the study’s primary endpoint. The change observed in hemoglobin levels on treatment with pegcetacoplan bettered Apellis’ most optimistic expectation to see 2 g/dL or more change in hemoglobin. Meanwhile, the study also showed promising results in key secondary endpoints. Pegcetacoplan was non-inferior to Soliris on transfusion avoidance and absolute reticulocyte count. The safety profile of pegcetacoplan was comparable to eculizumab in the study. Apellis plans to meet regulators in the first half of the year to discuss the next steps.
Apellis’ stock shot up 28.3% on Tuesday in response to the news. The company’s shares have risen 178% in the past year against 2.4% decrease registered by the Zacks Investment Research
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