Amgen, AstraZeneca PLC's Brodalumab Phase 3 Study Met All Primary Endpoints Against Johnson & Johnson's Stelara

November 26, 2014

By Jessica Wilson, BioSpace.com Breaking News Staff

Amgen and AstraZeneca today announced the results of another Phase III trial, this one named AMAGINE-2, which showed, once again, that the drug brodalumab was more effective than Johnson & Johnson ’s Stelara (ustekinumab) and a placebo at week 12 when tested on more than 1,800 patients with moderate-to-severe plaque psoriasis.

In the AMAGINE-2 study, 44.4 percent of patients who received 210 mg of brodalumab achieved total clearance of skin disease as measured by the Psoriasis Area Severity Index (PASI 100). In the group of patients that received a weight-based dosage of the drug, 33.6 percent of patients achieved total skin clearance. In the group of patients who received 140 mg of brodalumab, 25.7 percent of patients achieved total skin clearance. This compared to 21.7 percent of patients of patients who received Stelara and 0.6 of patients who received the placebo.

“AMAGINE-2 is the third and final pivotal study in our Phase 3 psoriasis program and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities,” Sean Harper, executive vice president of Research and Development at Amgen, said in a statement.

Brodalumab is an investigational drug 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 the development plaque psoriasis.

“These results confirm our belief that targeting the IL-17 receptor to inhibit inflammatory signaling can have significant benefit for psoriasis patients,” said Briggs Morrison, executive vice president of Global Medicines Development at AstraZeneca, was quoted as saying in the press release from the two companies.

Amgen and AstraZeneca announced results from AMAGINE-1, which compared brodalumab to a placebo, in May 2014. The companies announced top-line results from AMAGINE-3, which had the identical design as AMAGINE-2 and similar results, in mid-Nov. 2014.

When results from AMAGINE-3 were announced, investment analysts categorized brodalumab as a boon to the companies, as reported by BioSpace. “Based on positive results from Phase III AMAGINE-1 trial of brodalumab in psoriasis, we had expected a positive outcome from AMAGINE-3, but we believe brodalumab's superiority over Stelara is a clear win for Amgen,” Bret Holley, a biotech analyst with Guggenheim Securities, said in a note to investors earlier this month. Holley also estimated that sales of brodalumab could reach more than $2 billion in the psoriasis market.