Apogee Therapeutics (NASDAQ:APGE) outlined a series of near- and mid-term clinical milestones at TD Cowen’s 46th Annual Healthcare Conference, with management emphasizing upcoming durability data for its lead atopic dermatitis (AD) candidate zumilokibart (“Zumi”), a Phase III start by year-end, and additional readouts for a combination program aimed at second-line treatment.
Focus on durability and less frequent dosing in atopic dermatitis
Chief Executive Officer Michael Henderson said the company’s multi-year effort has centered on “transforming dosing” for AD and other Type 2 inflammatory diseases by reducing treatment burden versus currently available biologics. Henderson contrasted Zumi’s goal of maintenance dosing every three to six months with the every-two-week regimen used for Dupixent, noting that the company believes less frequent dosing could improve adherence and persistence.
Henderson framed the upcoming maintenance bar using the “responder analysis” concept described on Dupixent and Ebglyss labels: among patients who achieve EASI-75 or IGA 0/1 at week 16, what proportion maintains those responses through week 52. He cited approximately 72% maintenance for EASI-75 and 53% for IGA 0/1 for those comparator labels. Management also said Apogee’s study design randomizes all patients into maintenance regimens, not just responders, which the team said could give physicians a fuller picture of outcomes over a year.
Quarterly and semiannual dosing both expected in Phase III
Apogee said it intends to take both quarterly (every three months) and semiannual (every six months) maintenance regimens into Phase III. Henderson said having maintenance data ahead of Phase III is intended to reduce uncertainty around dose selection, including the potential to adjust the six-month dose if durability wanes compared with the three-month regimen.
Chief Commercial Officer Jeff Hartness said the company’s market research suggests quarterly dosing alone could be “transformative” for physicians and patients and that adding a six-month option could expand share and increase biologic adoption. Hartness said physician feedback in research indicated that a semiannual option could add incremental market share and support deeper penetration in a category where biologic use remains limited relative to overall patient volume.
Management also indicated the formulation could support higher dosing if needed, including the possibility of multiple injections for six-month administration.
Part B readout in Q2 to test higher-dose hypothesis
Management said Part B data are expected in the second quarter and described Part B as testing a higher dose to explore whether increased exposure could further improve efficacy. Henderson referenced an exposure-response relationship for IL-13 inhibition and pointed to commentary from the European assessment of lebrikizumab suggesting higher exposures in lower body-weight patients were associated with better outcomes in induction.
Henderson said Apogee’s own post-hoc Part A analysis suggested patients in the highest exposure quartile performed best, and that Part B is designed to evaluate whether higher exposure can “eke out more efficacy” beyond the mid-dose regimen. Chief Medical Officer Carl Dambkowski said the company would likely view a consistent improvement of roughly five percentage points or more across endpoints as potentially meaningful, while smaller differences could be difficult to distinguish from noise.
Safety discussion centered on conjunctivitis and class considerations
On safety, management said the known class-related adverse event for IL-13/Type 2 biologics is conjunctivitis, which they characterized as largely aesthetic and typically manageable. Henderson said higher exposure on Dupixent has been associated with lower conjunctivitis rates, and he described Apogee’s observed conjunctivitis duration as less than 30 days, contrasting it with a longer average duration he attributed to published Dupixent reporting. Management said it has not observed other adverse events sometimes discussed for Dupixent, including head and neck erythema, arthralgias, or eosinophilia.
Phase III plans and pipeline updates: head-to-head OX40 combination and expansion indications
Chief Financial Officer Jane Pritchett Henderson said Apogee expects to start Phase III by the end of 2026, following a familiar regulatory path of two replicate placebo-controlled trials. She added the company expects a third trial that includes topical corticosteroids (TCS) to support labeling. The company reiterated an aim to launch in 2029 and said it is funded into the second half of 2028, which management said should provide runway through Phase III top-line data.
Apogee also highlighted APG279, a combination approach that will be evaluated head-to-head against Dupixent, with data expected in the second half of the year. Henderson said the company’s strategic intent is to position Zumi as a frontline option and to develop a second-line therapy that could compete with JAK inhibitors by offering broader immunomodulation with a “cleaner” safety profile. Management said success in a Dupixent head-to-head setting would likely require an 8–10 point efficacy advantage supported by trends across multiple endpoints.
On OX40 ligand-related safety, Dambkowski described the company’s concern as “low to medium,” emphasizing monitoring and describing the reported Kaposi sarcoma events in the class as cutaneous cases with identifiable risk factors. He said surveillance via skin checks is feasible in dermatology settings and contrasted this monitoring approach with broader warnings and laboratory monitoring associated with JAK inhibitors. Dambkowski also estimated an incidence range of roughly 1 in 2,000 to 1 in 4,000, noting a potential link to higher-risk populations and HHV-8 seroprevalence.
Beyond dermatology, management discussed respiratory and gastrointestinal expansion. The company said it previously disclosed a Phase 1B study of Zumi in asthma showing magnitude and durability of “phenotypic suppression” out to 32 weeks, and it expects to provide trial designs for asthma and eosinophilic esophagitis (EoE) later this year. Apogee also said it will announce trial design later this year for its IL-13/TSLP combination program (APG273), noting that upcoming Part B dosing information and external readouts in the IL-13/TSLP space could inform its approach.
In closing remarks, Henderson said he believes investors may underappreciate how the company’s profile could change by year-end, describing an expected transition to a Phase III-stage company with additional pipeline optionality and expansion opportunities.
About Apogee Therapeutics (NASDAQ:APGE)
Apogee Therapeutics, Inc is a clinical-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics that selectively target the nuclear receptor RORγt, a master regulator of T cell-driven inflammatory pathways. By modulating RORγt activity, Apogee aims to offer an oral treatment option for patients with autoimmune and inflammatory skin disorders.
The company’s lead candidate, APG-157, is an oral RORγt inverse agonist currently undergoing early-stage clinical evaluation for moderate to severe plaque psoriasis.
