First Presentation of Phase III Data From Brodalumab Psoriasis Program
AstraZeneca & Amgen present results from Phase III AMAGINE-1 study evaluating brodalumab
AstraZeneca and Amgen today announced that additional results from AMAGINE-1™, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis will be presented at the Psoriasis: From Gene to Clinic International Congress in London on Saturday, 13 December 2014 at 11:20 am GMT (Abstract FC30). Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestations of plaque psoriasis.
“We are excited to present additional data from AMAGINE-1, which provide further insight into brodalumab’s potential role in addressing the unmet needs of patients living with psoriasis,” said Sean E. Harper, Executive Vice President of Research and Development at Amgen. “We continue to be encouraged by the emerging data from this program, and look forward to initiating global regulatory filings in 2015.”
The AMAGINE-1 trial assessed the safety and efficacy of brodalumab given every two weeks via subcutaneous injection at two doses (140 mg or 210 mg) compared with placebo after 12 weeks of treatment in patients with moderate-to-severe plaque psoriasis. Another purpose of the study was to assess safety and efficacy when patients treated with brodalumab, who responded to treatment, continued receiving brodalumab compared to patients who had treatment withdrawn and began receiving placebo. Data being presented includes results through week 52.
The AMAGINE program comprises three pivotal Phase III studies designed to assess the efficacy and safety of brodalumab in more than 4,200 patients with moderate-to-severe plaque psoriasis. Positive top-line results from AMAGINE-1 were released in May 2014. Positive top-line results from AMAGINE-2™ and AMAGINE-3™, comparing brodalumab with Stelara and placebo, were announced in November 2014. AMAGINE-2 and AMAGINE-3 are identical in design.
Stelara® is a registered trademark of Janssen Biotech, Inc.
About Brodalumab (AMG 827)
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.1 In addition to moderate-to-severe plaque psoriasis (Phase III), brodalumab is currently being investigated for the treatment of psoriatic arthritis (Phase III) and asthma (Phase II).
About the Amgen and AstraZeneca Collaboration
In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio. With oversight from joint governing bodies, Amgen leads clinical development and commercialisation for brodalumab (Phase III for moderate-to-severe plaque psoriasis and psoriatic arthritis, Phase II for asthma) and AMG 557/MEDI5872 (Phase Ib for autoimmune diseases, such as systemic lupus erythematosus). AstraZeneca, through its biologics arm MedImmune, leads clinical development and commercialisation for MEDI7183/AMG 181 (Phase II for ulcerative colitis and Crohn's disease), MEDI2070/AMG 139 (Phase II for Crohn’s disease) and MEDI9929/AMG 157 (Phase II for asthma).
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.