AstraZeneca AZN and its global biologics research and development arm, MedImmune announced disappointing top-line results from the TULIP 1 phase III study for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The phase III study did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE, as measured by the SLE Responder Index 4 (SRI4) at 12 months.
Anifrolumab is a developmental mAb that inhibits the activity of all type I interferons (IFN), which play a central role in lupus. SLE is a chronic autoimmune disease with significant unmet need.
The TULIP study includes two phase III clinical studies, TULIP 1 and TULIP 2, which are evaluating the efficacy and safety of anifrolumab compared with placebo in patients with moderately-to-severely active autoantibody-positive SLE who are receiving standard of care treatment.
Further, anifrolumab is also being tested in a phase III SLE long-term extension study, a phase II study using subcutaneous delivery in SLE and a phase II study for lupus nephritis.
Shares of the company have increased 10.5% year to date compared with the industry’s growth of 4.6%.
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There are very few medicines approved for SLE. Per GlaxoSmithKline plc GSK, its human monoclonal antibody, Benlysta (belimumab) is currently the only medicine specifically developed and approved for SLE. In March 2018, GlaxoSmithKlineinitiated a phase III study evaluating human monoclonal antibody, Benlysta (belimumab) in combination with Roche’s RHHBY anti-CD20 monoclonal antibody, Rituxan (rituximab) in adult patients with SLE. The main aim of the study is to evaluate whether the combination treatment achieves a state of low disease activity along with clinical remission in patients living with this chronic and unpredictable disease.
Zacks Rank & Stock to Consider
AstraZeneca has a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Gilead Sciences Inc. GILD, carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 5.7% so far this year.
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