AstraZeneca PLC AZN announced positive top-line results from the second phase III study on its human monoclonal antibody anifrolumab, currently under development for treating adult patients with moderate-to-severe systemic lupus erythematosus (SLE). The TULIP 2 study met the primary endpoint as treatment with anifrolumab showed a statistically-significant and clinically-meaningful reduction in disease activity compared to placebo with both arms receiving standard of care medicines.
The reduction was measured by the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52 of treatment.
This is the second phase III study on the candidate for SLE. Last August, the first study — TULIP 1 — on anifrolumab failed to meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE per the SLE Responder Index 4 (SRI4) measurement at 12 months.
AstraZeneca plans to present data from both TULIP 1 and TULIP 2 studies at an upcoming medical conference.
SLE is a chronic autoimmune disease with significant unmet need. Anifrolumab is a developmental monoclonal antibody that inhibits the activity of all type I interferons (IFN), which play a central role in lupus.
Further, anifrolumab is also being tested in a phase III long-term extension study for SLE and a phase II study for lupus nephritis as part of the TULIP program.
Shares of AstraZeneca have rallied 19.5% so far this year against the industry’s decrease of 1.7%.
We would like to remind investors that currently, there are a very few medicines approved for SLE with only one winning the nod in the last 60 years. GlaxoSmithKline’s GSK human monoclonal antibody Benlysta (belimumab) is currently the only medicine specifically developed and approved for SLE.
A potential approval for anifrolumab upon review will help AstraZeneca gain access to the lucrative SLE patient population.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include Merck & Co., Inc. MRK and Novartis AG NVS, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have moved 3.2% north for 2019 and 1.3% for 2020 over the past 60 days. The stock has gained 13.5% year to date.
Novartis’ earnings estimates have been revised 2.8% upward for 2019 and 2.9% for 2020 over the past 60 days. The stock has inched up 5.5% year to date.
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