Shares of AnaptysBio, Inc. ANAB, a clinical-stage biotechnology company, plunged 32.8% on Dec. 11 after it announced that the phase IIb study of pipeline candidate, ANB032, a BTLA agonist, was unsuccessful.
Consequently, ANAB discontinued any further investment in this asset.
AnaptysBio has lost 27.6% so far this year compared with the industry’s decline of 8.1%.
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More on ANAB’s Study Failure
The ARISE-AD study evaluated the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of ANB032 monotherapy in patients with moderate-to-severe atopic dermatitis (AD) or eczema.
The study enrolled 201 patients with a mean baseline EASI score of 27.3 in the United States, Canada, Europe, Australia and New Zealand. These patients were either biologics naïve (n=168) or biologics experienced (n=33), defined as having received treatment with dupilumab or other IL-13 therapies.
Patients were randomized to receive for 12 weeks either 100mg of subcutaneous ANB032 every four weeks (Q4W), 400mg every four weeks (Q4W) or 400mg every two weeks (Q2W), or placebo. The primary and secondary endpoints were assessed at week 14.
However, ANB032 did not meet the primary endpoint of the proportion of patients who achieved at least a 75% improvement from baseline in Eczema Area and Severity Index score (EASI-75), irrespective of the patient type.
ANB032 also did not meet any of the secondary endpoints at week 14, including EASI-90, mean change in baseline EASI or a 4-point reduction in itch severity as measured by the peak Pruritus Numerical Rating Scale (PNRS) as compared with placebo.
While absolute response rates on key endpoints in patients treated with ANB032 approached the minimum target product profile with durable off-drug responses, higher placebo rates outside of the historical norm were observed particularly in the United States.
Nonetheless, ANB032 was well tolerated across all doses with no safety signals observed.
Due to the disappointing efficacy data from the study, ANAB will discontinue further investment in this asset.
ANAB to Focus on Other Candidates Now
ANAB will share top-line data on its lead candidate rosnilimab, a depleter and agonist targeting PD-1+ T cells, from the rheumatoid arthritis study in February 2025 and top-line data from the phase II for the treatment of ulcerative colitis data in the first quarter of 2026.
Other antibodies in its portfolio include ANB033, an anti-CD122 antagonist, in a phase I study and ANB101, a BDCA2 modulator, soon to enter clinical development.
Anaptys also has an immuno-oncology collaboration with GSK plc GSK. It discovered multiple therapeutic antibodies which have been licensed to GSK, including an anti-PD-1 antagonist, Jemperli, and an anti-TIM-3 antagonist (cobolimab, GSK4069889).
The company currently recognizes revenues from milestones and royalties achieved under its collaboration with GSK.
ANAB expects that cash balance of approximately $415 million at the end of 2024 and will extend its cash runway guidance through year-end 2027, excluding potential GSK milestones and royalties.
ANAB’s Zacks Rank and Stocks to Consider
AnaptysBio currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR and Castle Biosciences, Inc. CSTL, each carrying 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.33 to $1.57 during the same time frame. Year to date, shares of IMCR have lost 55%.
IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%.
In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from $2.13 to $1.84. Year to date, shares of CSTL have surged 36.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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