GlaxoSmithKline plc (GSK - Free Report) announced encouraging data from a pivotal phase III study on Nucala (an IL-5 antagonist) in patients with relapsing and refractory eosinophilic granulomatosis with polyangiitis (EGPA; previously known as Churg-Strauss syndrome).
The randomized, double-blinded study was conducted to evaluate the efficacy and safety of Nucala 300 mg (administered subcutaneously every four weeks), in comparison to placebo, over a 52-week study treatment period in patients with relapsing or refractory EGPA receiving standard-of-care therapy including background corticosteroid therapy with or without immunosuppressive therapy.
Data showed that Nucala met both the co-primary endpoints of the study, including the duration of remission as defined by the proportion of patients experiencing at least 24 weeks duration of remission, which was found to be 28% for Nucala and 3% for placebo. Moreover, the proportion of patients attaining remission at week 36 and week 48 of the study period were 32% for Nucala and 3% for placebo. The difference in results for the two treatment groups was statistically significant for both the co-primary endpoints.
Moreover, patients demonstrated statistically significant differences in favor of Nucala for all secondary endpoints assessing relapse, remission and corticosteroid use, in comparison to placebo.
The recently reported results are expected to support the submission of regulatory applications for Nucala for the treatment of relapsing and refractory EGPA in 2017.
Glaxo intends to submit full data from the study for presentation at a forthcoming scientific congress and for publication in a peer-reviewed journal. The study was conducted as part of an agreement between Glaxo and the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.
Per Glaxo’s press release, EGPA is one of the rarest systemic vasculitic (inflammation of blood vessel walls) diseases. Its global incidence is usually in the range 1–4 per million, with an estimated prevalence of nearly 14–45 per million.
Although the use of corticosteroid therapy with concomitant immunosuppressive therapy and/or cytotoxic agents can be effective for establishing remission, patients remain susceptible either to the complications of long-term use of these therapies, or to the risk of relapse, particularly if the dose of corticosteroid is reduced. Considering the limited treatment options, there is significant unmet need for drugs addressing this rare systemic inflammatory disease.
We note that Nucala is already approved in the U.S. as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, who have an eosinophilic phenotype. It is also approved in the EU for use as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
The drug’s uptake has been encouraging so far. A label expansion should boost its sales further.
Zacks Rank & Key Picks
Glaxo currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. (SCMP - Free Report) , Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . While Sucampo and Vanda sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017, over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged 86% year to date.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained approximately 23% year to date.
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