Apogee Therapeutics has published phase 2 eczema data that suggest its anti-IL-13 antibody is a threat to Eli Lilly, Regeneron and Sanofi, prompting analysts to double their peak sales forecast to $5.2 billion.
The data come from the maintenance stage of a phase 2 trial. At the end of the induction period, Apogee re-randomized all patients in the zumilokibart cohort to receive the anti-IL-13 antibody every three or six months. After 52 weeks, 85% of patients randomized to the six-month regimen maintained the 75% improvement on the EASI symptom scale they achieved during the induction stage.
At 75%, the EASI maintenance rate was lower on the three-month regimen. But Guggenheim Securities analysts said in a note to investors that both regimens performed at least as well as Eli Lilly’s Ebglyss and Sanofi and Regeneron’s Dupixent, based on cross-trial comparisons. The analysts quoted EASI-75 maintenance rates of 82% and lower for Ebglyss and 72% for Dupixent.
Data on zumilokibart’s maintenance of vIGA 0/1 outcomes, which indicate clear or almost clear skin, also compared favorably to results for Ebglyss and Dupixent. Apogee reported vIGA 0/1 maintenance rates of 86% and 78%, respectively, for the three- and six-month regimens. The analysts compared the results to a rate of 54% for Dupixent and up to 77% for Ebglyss.
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Ebglyss was given every two or four weeks in the trial data referenced by the analysts, while Dupixent was administered every one or two weeks. While cross-trial comparisons can be unreliable, the data suggest zumilokibart can achieve at least comparable maintenance rates despite being given less frequently. The maintenance data exceeded the Guggenheim analysts’ expectations.
While praising the maintenance results, the analysts said the deepening response rates across all key endpoints were the most surprising and impressive aspect of the data. The proportion of patients who had 75%, 90% and 100% improvements on the EASI scale increased between the Week 16 and Week 52 analyses. Apogee also reported deepening responses on vIGA 0/1 and on a measure of itch symptoms.
The analysts said the Week 52 results look comparable to data on AbbVie’s blockbuster JAK inhibitor Rinvoq. Monotherapy trials of Dupixent and Ebglyss randomized only responders to maintenance doses, preventing direct comparisons to the vIGA data beyond the maintenance results. The analysts said there was minimal if any deepening of responses after Week 16 in a Dupixent combination trial.
Encouraged by the data, the analysts said they are increasingly convinced that zumilokibart will become the first-line treatment for most eczema patients. The prediction reflects the drug candidate’s dosing schedule and its “improving” efficacy profile, the analysts said.
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In eczema, the analysts expect peak sales of $5.2 billion, up from $2.6 billion before the data drop. The forecast reflects the potential for zumilokibart to claim a larger share of the market than expected. The analysts see chances for Apogee to unlock more sales by moving into indications including eosinophilic esophagitis, where weekly dosing is the current standard of care.
Apogee shares rose 20% to $80 when markets opened Monday from a Friday closing price of $66.04.
