In the wake of each dosing arms' failure to hit the primary endpoint in Anaptysbio Inc.'s phase IIb study of etokimab to treat moderate to severe atopic dermatitis (AD), the stock dropped steeply and the company postponed initiating its phase IIb etokimab trial in eosinophilic asthma until it analyzes the phase IIb result.
The failure also dropped a potential competitor to Regeneron Pharmaceutical Inc.'s FDA-approved blockbuster, Dupixent (dupilumab), as Pfizer Inc. and Dermira Inc. have advanced their AD candidates in recent months.
While San Diego-based Anaptysbio (NASDAQ:ANAB) also reported positive top-line data Friday from its interim analysis the GALLOP phase II study of ANB-019 as a monotherapy in moderate to severe generalized pustular psoriasis, company shares closed at $10.18, down 71.8% on the day.
RBC Capital Markets analysts expressed shock at the phase IIb results and by Anaptysbio's management's side-stepping of a conference call to chat about it all.
"We're surprised by this outright failure as well as the lack of an investor call to discuss the most significant development in the history of the company," they wrote, adding that they anticipated "increased skepticism around the value attributed to this asset."
It wasn't just the silence on the phone that didn't sit well with the analysts over at Jefferies on Friday. The failure "to disclose any numbers related to the primary endpoint does not provide any insights into the study's failure and we think shareholders deserve this information, and also deserved a conference call to discuss the data," they wrote. "For full disclosure, [management] previously stated both p-values and the treatment effect would be provided when the data are announced."
The Anaptysbio press release noted that it anticipates top-line data from an interim analysis of its phase II ECLIPSE trial in the first quarter of 2020 and that rubbed Jefferies analysts the wrong way, too, as they wrote that "the type of analysis has changed from final to an interim analysis. Even if positive, we don't think it would be commercially promising."
ECLIPSE is testing the drug in about 100 adults with chronic rhinosinusitis with nasal polyps. Patients are being treated with two multidosing frequencies of subcutaneously administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy.
With Anaptysbio's phase IIb failure with etokimab in AD, Pfizer and Dermira have less competition in the rush toward approval as they take on a field dominated by Dupixent.
In late September, Pfizer reported positive top-line results from a phase III trial evaluating the efficacy and safety of its oral JAK1 inhibitor, abrocitinib, the second of two monotherapy trials in Pfizer's JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. The randomized, double-blind, placebo-controlled, parallel-group study was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of abrocitinib monotherapy over 12 weeks. At week 12, the percentage of patients, ages 12 and older, with moderate to severe AD hit each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib, performing statistically significantly higher than placebo. Also, a statistically significant number of patients achieved a reduction in pruritus by week two, as measured by a four-point or larger reduction in itch severity measured with the pruritus numerical rating scale (NRS). (See BioWorld, Sept. 30, 2019.)
Dermira had a good day on the market Friday as its stock (NASDAQ:DERM) rose 18% to close at $8.23. Earlier this year, data from Dermira's midstage study revealed its candidate, lebrikizumab (lebri), in AD showed a monthly dose performing roughly in line with Dupixent. Though no head-to-head test with Dupixent was included in Dermira's phase IIb study, three different doses of lebri outperformed a placebo on a standard measure of eczema severity, showing efficacy that analysts said nearly matched Regeneron's drug. (See BioWorld, March 19, 2019.)
Dermira dosed the first patient in early October in its phase III trial of lebrikizumab in adult and adolescent patients ages 12 and older with moderate to severe AD. Lebrikizumab is a monoclonal antibody designed to bind IL-13, preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13.