Amgen has reported positive top-line data from the Phase III DAHLIA clinical trial of ABP 959 in adults with paroxysmal nocturnal hemoglobinuria (PNH).
ABP 959 is an investigational biosimilar candidate to Soliris (eculizumab).
The double-blind, randomised, active-controlled, two-period crossover trial analysed the safety and efficacy of ABP 959 versus Soliris in adult PNH patients, who priorly received eculizumab for a minimum of six months.
Trial subjects were categorised into a 1:1 ratio to receive each investigational product (IP) in one of two sequences over two periods, with a crossover.
According to the findings, the trial met the primary endpoints.
No clinically meaningful variations between ABP 959 and Soliris were reported at week 27, based on intravascular haemolysis control as assessed by lactate dehydrogenase (LDH).
In the time-adjusted area under the effect curve (AUEC) of LDH, no clinically meaningful differences from week 13 to 27, from week 39 to 53, and from week 65 to 79 for the crossover comparison were observed.
In the trial, ABP 959’s safety and immunogenicity profiles were in line with Soliris.
A monoclonal antibody, ABP 959 attaches to the complement protein C5 and hinders classical and alternative complement cascade progression.
Amgen Research and Development executive vice-president David Reese said: “The positive results with ABP 959 demonstrate similar efficacy, safety and immunogenicity as the reference product, further highlighting Amgen’s commitment to providing patients with access to high-quality, biologic therapies.
“We look forward to working with regulators to make this potential biosimilar option available to patients.”
The company’s portfolio has 11 biosimilars, of which five have obtained approval in the US, three are approved in the European Union, and three are in the Phase III development stage.
In April this year, the company reported that the Phase III trial of ABP 654 in adult patients with moderate to severe plaque psoriasis met the primary efficacy endpoint.