Connect Biopharma celebrates a mid-stage win for its Dupixent rival, but shares tank after investors clamor for data
A suite of drugmakers is looking to topple Dupixent in the eczema market — and on Thursday, China-based Connect Biopharma uncorked some mid-stage results it says will pave the way to a pivotal trial. But investors want hard numbers, and without any to share, the company’s stock $CNTB plunged more than 50% on Friday.
Connect’s monoclonal antibody CBP-201 met the primary endpoint in a Phase II trial, showing significant improvements in Eczema Area and Severity Index (EASI) scores in all three dose groups, according to the biotech. The treatment arms — 300 mg every two weeks, 150 mg every two weeks, or 300 mg every four weeks — were all statistically superior to placebo at Week 16, and all showed significant improvements in the proportion of patients achieving at least a 50% or 75% reduction in EASI score (EASI-50 or EASI-75, respectively).
The company also said, again without showing hard data, the 300 mg dose given every two weeks met key secondary endpoints, including the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ≥2 points from baseline at Week 16. Patients who took CBP-201 also saw a significant change from baseline in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS), Connect reported.
The biotech promised to spell out the data in a conference call before the end of January — but for some investors, that’s not soon enough. Connect shares were down more than 53% by mid-morning, pricing in at $5.64.
CEO and co-founder Zheng Wei remained positive, announcing plans to launch a Phase III trial in mid-2022.
“This global Phase 2 trial is also an important milestone in informing us of the potential of CBP-201 in other indications currently being studied, including moderate-to-severe persistent asthma and chronic rhinosinusitis with nasal polyps,” he said in a statement.
The incidence of serious and treatment-related side effects was similar in both the treatment and placebo arms, Connect said. About 1.8% of patients who took the drug experienced injection site reactions, and 3.5% came down with conjunctivitis.
Wei met Connect’s other co-founder, William Pan, in a molecular biology study group in college in Guangzhou, China. They’ve come a long way since founding Connect in 2012, completing a $115 million Series C round last August to propel their pipeline into Phase III. The company’s other lead candidate, CBP-307, is in Phase II for ulcerative colitis and Crohn’s disease.
CBP-201 works by inhibiting IL-4Rα signaling, thus controlling the signaling of IL-4 and IL-13, two cytokines involved in the generation of allergic diseases, the biotech says.
Dupixent, first approved to treat eczema in adults back in 2017, also targets IL-4Rα, pulling in more than $3.9 billion in 2020. Depending on which dose Connect chooses to move forward with, it could have the upper hand in convenience — Dupixent is typically administered in 300 mg doses every other week.
Other rivals, like Eli Lilly, Pfizer and Amgen, are a bit further along than Connect. Lilly said in August that its monoclonal antibody lebrikizumab met the primary endpoint in two Phase III trials, with more than half of patients on the drug achieving EASI-75. That same month, Pfizer reported results from a head-to-head study that suggested its JAK inhibitor Cibinqo was “statistically superior” to Dupixent. A month later, it was approved in the UK to treat moderate to severe atopic dermatitis.
Amgen bet $400 million upfront on Kyowa Kirin’s antibody back in June, and announced in October that the candidate met its primary endpoint in a Phase II study.
Sensing that competition was afoot, Sanofi and Regeneron read out pivotal data for the treatment of children between 6 months to 5 years old back in August. When given Dupixent on top of standard of care topical corticosteroids, 28% of patients achieved clear or almost clear skin compared to 4% of those on placebo, meeting the primary endpoint.
“Even with Dupixent, there’s still a lot of space to be improved,” Wei told Endpoints News last summer, adding that Connect hopes to beat the blockbuster drug in efficacy measures.