AstraZeneca ( AZN ) and partner Amgen ( AMGN ) announced encouraging results from the pivotal, multi-arm phase III AMAGINE-2 study (n>1800) on their psoriasis candidate, brodalumab. The study compared brodalumab with both Johnson & Johnson's ( JNJ ) Stelara and placebo in treating patients suffering from moderate-to-severe plaque psoriasis.
Results showed that a greater proportion of patients treated with brodalumab 210 mg (44.4%), brodalumab weight based group (33.6%) and brodalumab 140 mg (25.7%) achieved total clearance of skin disease as measured by the Psoriasis Area Severity Index (PASI 100). In comparison, patients under Stelara achieved 21.7% and under placebo a mere 0.6%.
Moreover, according to the PASI 75 score (at least a 75% improvement in disease severity), results showed that a higher number of patients on brodalumab 210 mg (86.3%) and the brodalumab weight based group (77%) achieved the same as compared to those on brodalumab 140 mg (66.6%), Stelara (70%) and placebo (8.1%). The other key secondary endpoints of the study were also met.
We note that the companies' AMAGINE program consists of three phase III studies - AMAGINE-1, AMAGINE-2 and AMAGINE-3. While results from the AMAGINE-1 study were out in May this year, AstraZeneca and Amgen announced encouraging results from the AMAGINE-3 study earlier in the month (read more: AstraZeneca/Amgen's Brodalumab Positive in Psoriasis Trial ).
With results from all the three studies out, the companies are now planning to discuss with regulatory authorities the global filing plan for the candidate which is expected next year.
Our Take
We are encouraged by the positive results from the AMAGINE program on brodalumab. Brodalumab is an important candidate for both AstraZeneca and Amgen. However, the psoriasis market currently looks extremely crowded with the presence of products like Stelara, Enbrel and Otezla.
Brodalumab is also being developed for the treatment of asthma. According to AstraZeneca, analyst estimates for brodalumab range between $0.5 billion and $1.5 billion.
Amgen and AstraZeneca are both Zacks Rank #3 (Hold) stocks. A better-ranked stock in the health care sector is Allergan Inc. ( AGN ) carrying a Zacks Rank #1 (Strong Buy).
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
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AstraZeneca/Amgen's Brodalumab Excels in Psoriasis Study - Analyst Blog
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