Biogen Inc. BIIB, along with its Belgian partner UCB, announced positive topline data from the phase III PHOENYCS GO study, which evaluated the investigational drug candidate, dapirolizumab pegol, for the treatment of moderate-to-severe systemic lupus erythematosus (SLE).
SLE is a chronic and debilitating autoimmune disease that can affect multiple organ systems.
The study met the primary endpoint by demonstrating clinical improvement in moderate-to-severe SLE.
Year to date, shares of Biogen have plunged 25% compared with the industry’s 1.5% decline.
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BIIB's PHOENYCS GO Study Meets Key Goals
The double-blind, placebo-controlled phase III PHOENYCS GO study evaluated dapirolizumab pegol as an add-on therapy to standard-of-care (SOC) versus placebo with SOC for treating SLE.
Data from the study showed that dapirolizumab pegol, in combination with SOC, led to greater improvement in moderate-to-severe disease activity as assessed by the achievement of British Isles Lupus Assessment Group -based Composite Lupus Assessment after 48 weeks compared with placebo in addition to SOC. This was the primary endpoint of the study.
The study also demonstrated clinical improvements in key secondary endpoints measuring disease activity and flares.
The safety profile of dapirolizumab pegol was similar to that seen in previous studies.
Per management, the data from the PHOENYCS GO study underlines the fact that dapirolizumab pegol has the potential to be useful in the treatment of SLE.
Following the PHOENYCS GO study's success, BIIB and UCB plan to initiate a second phase III study – PHOENYCS FLY – on dapirolizumab pegol in 2024.
Other Players in the SLE Market
If successfully developed and approved, Biogen and UCB’s dapirolizumab pegol is likely to face some competition from drugs that are currently approved for treating SLE.
AstraZeneca’s AZN Saphnelo (anifrolumab) is approved for the treatment of moderate-to-severe SLE. Also, GSK plc’s GSK immuno-inflammation drug, Benlysta (belimumab), is approved for treating SLE and lupus nephritis.
AZN’s new lupus drug, Saphnelo, generated sales worth $203 million in the first half of 2024. AstraZeneca is also developing Saphnelo in a phase III study for treating systemic sclerosis.
GSK’s Benlysta has been in the market for quite some time. The drug generated sales worth £678 million in the first half of 2024. Per GSK, Benlysta sales are being driven by strong demand and volume growth in the United States, European and International markets.
Zacks Rank & a Stock to Consider
Biogen currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is ANI Pharmaceuticals, Inc. ANIP, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 6.1%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
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