Lebrikizumab

The case for IL-18 inhibition to treat inflammatory skin diseases may have just gotten stronger. Evommune on Tuesday posted a mid-stage win for its long-acting fusion protein EVO301 — which combines an IL-18 binding protein with an anti-serum albumin Fab-associated domain — in atopic dermatitis (AD). The news sent company shares rocketing up close to 80%.The biotech, which made its public debut in November, is evaluating EVO301 in a 70-patient Phase IIa trial. Participants received a 5mg/kg intravenous dose of the candidate, or placebo, on the first day of the study and on day 28. Evommune reported that the fusion protein met its primary endpoint, a Bayesian success criterion that measured the difference in percent improvement between the treatment arm and placebo from baseline on the Eczema Area and Severity Index (EASI).Specifically, patients taking EVO301 saw a 33% placebo-adjusted improvement in EASI score at week 12, meeting a benchmark set last month by Oppenheimer analysts. In a January note, the analysts relayed feedback from a key opinion leader (KOL), who said EVO301 would be a "differentiated product" if it achieved placebo-adjusted EASI-75 improvement of roughly 30% to 35% — similar efficiency as market leaders Dupixent (dupilumab) or Ebglyss (lebrikizumab) — while maintaining a well-tolerated safety profile, with ideally every-four-week dosing.  "Despite mixed prior results with IL-18 biologics, the KOL cited growing support for the IL-18 target in AD," they wrote.Evommune also noted that 23% of those in the EVO301 treatment group achieved a score of 0 or 1 on the Investigator’s Global Assessment for Atopic Dermatitis at week 12, meaning their skin was clear or almost clear from disease. "These data support our plans to move EVO301 into a Phase IIb dose-ranging trial where we can optimise the dose and seek to further improve patient outcomes," said CEO Luis Peña, noting that the study will evaluate a subcutaneous version of the candidate. The company plans to share full results from the Phase IIa study at an upcoming scientific conference, and is also considering studying EVO301 in ulcerative colitis. Evommune is also expecting topline data this year from a pair of Phase IIb studies of its second programme, EVO756, an oral MRGPRX2 antagonist. Data in chronic spontaneous urticaria are due this half, while findings in AD are slated for next half. If the upcoming readouts are also positive, the Oppenheimer analysts suggested Evommune could be "an attractive acquisition target given broad applicability across various inflammatory indications."

Dive Brief:An experimental eczema shot from Nektar Therapeutics helped trial enrollees whod already benefited from treatment maintain and even deepen their response over one year after being switched to a longer-lasting maintenance dose, the company said Tuesday.The data, if confirmed in additional testing, could give Nektars shot a competitive advantage over Regeneron and Sanofis Dupixent and Eli Lillys Ebglyss by offering deepening effects with less-frequent dosing. But Nektar also faces competition from many others advancing different types of injectables and oral medicinesfor the condition.Nektar is planning a Phase 3 trial with a similar design that will allow responders to transition to a maintenance dose while others continue on with the initial regimen. If successful, the company expects to ask the Food and Drug Administration for approval in 2029.Dive Insight:Nektar shares were worth less than $10 apiece only a few years ago, when efforts to develop a cancer immunotherapy with Bristol Myers Squibb fell short. But shares have rebounded considerably since the middle of 2025. And they climbed as much as 48% in morning trading, nudging the valuation of the 36-year-old company over the $1 billion mark as investors gained confidence in the potential of its drug, called rezpegaldesleukin.The drug targets IL-2, a protein that stimulates a type of white blood cell that helps keeps erroneous immune responses in check.Nektar is testing the approach a common strategy against cancer in multiple autoimmune conditions, including eczema,alopecia areata and Type 1 diabetes.The data Nektar announced Tuesday came from the second part of a trial in eczema that was already declared a success. In the first stage of that trial, Nektarwas able to show that a significantly greater share of people who received rezpegaldesleukininstead of a placebo achieved certain measures of skin clearance. That measurement was taken after trial enrollees had received different doses of rezpegaldesleukineither fortnightly or monthly.In the studys second phase, 167 of the 320 participants who got Nektars drug and achieved a specific level of skin clearance EASI50 or greater were then given additional treatment at different dose intervals over 36 weeks. Most of those regimens involved less frequent dosing than what patients received at the studys start.Additionally, 23 people in the placebo arm who achieved EASI50 continued getting a placebo. Placebo and drug recipients who didnt hit that mark were allowed into a rescue arm of the trial that got rezpegaldesleukintreatment.Nektar said the majority of people who entered the second stage maintained their response, as measured by the EASI scale, a separate assessment and a measurement of itching. A meaningful proportion of those in the second stage saw an even deeper response such as meeting more strict measures of skin clearance than theyd achieved in the initial part of the trial.In a note to clients Tuesday, Jefferies analyst Roger Song wrote that the new data exceeded our expectations and surpassed benchmarks set by other therapies. '