Pfizer is ramping up plans for tilrekimig after a phase 2 win raised hopes that the once-monthly trispecific antibody could hold its own against approved eczema drugs.
The Big Pharma evaluated three once-monthly doses of tilrekimig—which targets IL-4, IL-13 and thymic stromal lymphopoietin (TSLP)—against placebo in adults with moderate to severe atopic dermatitis. The phase 2 trial hit is primary endpoint of demonstrating a statistically significant increase in the proportion of patients who saw the size and severity of their eczema reduce by over 75% at Week 16 across all three doses, Pfizer explained in a March 9 release.
Specifically, the low-, middle- and high-dose groups saw 38.7%, 51.9% and 49.4% of patients, respectively, hit this EASI-75 mark when adjusted for placebo.
Pfizer said the results of the medium- and high-dose cohorts “strongly suggest potentially meaningful improvements to approved standard of care biologics.”
While many pharmas have worked on eczema drugs, some have struggled to prove their worth against Sanofi and Regeneron’s blockbuster Dupixent. Johnson & Johnson junked a dermatitis candidate in January after conceding the IL-4 and Il-31 inhibitor was unlikely to succeed in a head-to-head with Dupixent.
While comparing trials should be treated with caution, this morning’s tilrekimig data appear to hold their own against Dupixent. A dose of Dupixent every two weeks has been shown to achieve EASI-75 for 51% and 54% of patients, respectively, at Week 16 in a pair of studies.
Buoyed by this morning’s data, Pfizer said it was accelerating its plans for tilrekimig, with the launch of a phase 3 atopic dermatitis study expected this year.
“We are encouraged by the topline phase 2 results for tilrekimig, which show that combining the potent inhibition of IL-4/13 and TSLP pathways has the potential to deliver improved efficacy over the standard of care for atopic dermatitis,” Mike Vincent, M.D., Ph.D., chief inflammation and immunology officer at Pfizer, said in a release.
“We plan to advance a broad clinical development program for tilrekimig, a potential first-in-class trispecific antibody discovered at Pfizer, in atopic dermatitis and other Th2-mediated inflammatory diseases including asthma and COPD,” Vincent added.
When it came to safety, Pfizer said tilrekimig was well tolerated, with adverse event (AE) rates “comparable to placebo.” The most common AEs were infections and infestations, skin and subcutaneous tissue disorders and general disorders, as well as administration site reactions.
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Pfizer is already studying tilrekimig in a phase 2 study in asthma as well as a phase 2b/3 study in chronic obstructive pulmonary disease. The company disclosed in this morning’s release that it had tested a high dose of tilrekimig alongside another in-house trispecific called ompekimig in atopic dermatitis. Both tilrekimig and ompekimig, which inhibits IL-4, IL-13 and IL-33, met the study’s primary endpoint, according to Pfizer.
One of the selling points of tilrekimig as a trispecific is that as well as inhibiting two types of interleukin, it also targets TSLP. Both TSLP and various interkleukin proteins are released in the body in response to allergens, viruses, pollution and mechanical stimuli.
Last month, Generate:Biomedicines was able to score a $400 million IPO to fund phase 3 asthma trials of its anti-TSLP antibody, while Upstream Bio’s TSLP antagonist demonstrated a Tezspire-like reduction in asthma exacerbations in a phase 2 trial.