Back to top

Image: Bigstock

AstraZeneca's Lupus Drug Meets Primary Endpoint in Study

Read MoreHide Full Article

AstraZeneca PLC (AZN - Free Report) 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 - Free Report) 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 - Free Report) and Novartis AG (NVS - Free Report) , 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.

Today's Best Stocks from Zacks

Would you like to see the updated picks from our best market-beating strategies? From 2017 through 2018, while the S&P 500 gained +15.8%, five of our screens returned +38.0%, +61.3%, +61.6%, +68.1%, and +98.3%.

This outperformance has not just been a recent phenomenon. From 2000 – 2018, while the S&P averaged +4.8% per year, our top strategies averaged up to +56.2% per year.

See their latest picks free >>


In-Depth Zacks Research for the Tickers Above


Normally $25 each - click below to receive one report FREE:


AstraZeneca PLC (AZN) - free report >>

GlaxoSmithKline plc (GSK) - free report >>

Merck & Co., Inc. (MRK) - free report >>

Novartis AG (NVS) - free report >>