Celgene Corporation CELG announced that the phase III study, STYLE, on plaque psoriasis drug, Otezla, met its primary endpoint.
The phase III, multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of Otezla in patients with moderate to severe plaque psoriasis of the scalp. The study enrolled 303 people, who were randomized in the ratio of 2:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks.
Results of the study showed that Otezla 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment (ScPGA) response at week 16 compared with placebo.
The study also met its secondary endpoint of the whole body itch numeric rating scale (NRS) — defined as at least a 4-point reduction from baseline — at week 16 with Otezla versus placebo.
No new safety signals were identified in the trial.
We note that Otezla is approved for the treatment of patients with moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
Otezla sales were $728 million, up 21.3% from the year-ago quarter. Otezla is currently being evaluated in phase III studies for Behçet's disease, atopic dermatitis, and expanded indications in psoriatic arthritis and plaque psoriasis. Global submissions are planned in 2018. The label expansion of the drug should boost sales.
In the last month, Celgene announced encouraging results from two post hoc sub-analyses of clinical trials for psoriasis drug, Otezla at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris, France. Per the data presented in the congress, usage of Otezla resulted in meaningful improvements in outcomes important to patients with moderate to severe plaque psoriasis, which may not be captured by common measures of treatment efficacy that focus only on skin clearance, such as Psoriasis Area Severity Index (PASI) 75. Meaningful improvements in skin, itch and quality-of-life measures were observed in treatment with Otezla. Additionally, a separate post hoc sub-analysis of data from the phase III ESTEEM 1 and 2, and phase IV UNVEIL trials showed improvement in areas such as scalp and nails with Otezla compared to placebo.
After a series of setbacks, things are finally looking good for the company. Celgene and partner Acceleron Pharma XLRN recently reported positive results from two phase III studies on luspatercept. Luspatercept achieved all primary and key secondary endpoints in the phase III MEDALIST and BELIEVE trials, in patients with low-to-intermediate risk myelodysplastic syndromes (MDS) and transfusion-dependent beta-thalassemia, respectively.
Celgene’s stock tumbled 16.1% in the last six months compared with the industry's decline of 10.3%.
Earlier, Celgene announced a global collaboration with Prothena PRTA to develop new therapies for a broad range of neurodegenerative diseases, primarily focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, TDP-43 and an undisclosed target.
The company also has development and co-promotion agreement with bluebird bio, Inc. BLUE. Both companies entered into a deal to co-develop and co-promote bb2121, an experimental anti-B-cell maturation antigen chimeric antigen receptor CAR-T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States.
Hence, we expect a better performance in the second half of 2018 followed by an eventful 2019 for Celgene.
Celgene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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