Executives from Apogee Therapeutics (NASDAQ:APGE) outlined their development and commercialization priorities at Guggenheim’s Emerging Outlook Biotech Conference, emphasizing plans to shift treatment for atopic dermatitis (AD) toward substantially less frequent dosing while expanding the company’s reach into respiratory indications and combination therapies.
Strategy centers on long-duration dosing for atopic dermatitis
Chief Executive Officer Michael Henderson said Apogee was founded roughly four years ago with the goal of improving options for patients with AD and related conditions. He pointed to Phase II data discussed as showing rapid itch relief and lesional benefits, and he framed the next near-term milestone as demonstrating that the company can move dosing from an every-two- to four-week paradigm to an every-three- to six-month paradigm without sacrificing efficacy.
Phase 1b asthma readout highlights biomarker reduction and durability
Chief Medical Officer Carl Dambkowski reviewed Apogee’s earlier Phase 1b asthma update, which included 19 mild-to-moderate asthma patients. He said the trial focused on the magnitude and durability of reduction in fractional exhaled nitric oxide (FeNO), describing FeNO as a biomarker correlated with annualized exacerbation rate (AER), an endpoint used for approvals.
Dambkowski said the study showed up to a 60% reduction from baseline in FeNO (or 45 parts per billion) and described the effect as durable, with data through 16 weeks appearing “very flat” and additional available data extending out to eight months as the study continues. He characterized the magnitude as competitive with other agents, while emphasizing durability as a key differentiator for less frequent dosing.
Chief Commercial Officer Jeff Hartness argued that an asthma label could materially expand the AD opportunity due to comorbidity, citing an estimated 30% overlap between AD and asthma. He said adding asthma would deepen engagement with allergists and expand into pulmonologist offices, and he highlighted payer leverage from potentially being one of two products positioned to address both AD and asthma for that overlapping patient segment. Hartness also referenced Dupixent’s leadership in asthma despite every-two-week dosing, stating it is on track to exceed $5 billion in asthma sales by 2028.
How Apogee framed upcoming AD maintenance data and safety expectations
Management emphasized three attributes they said matter most to patients, physicians, and payers: rapid itch relief, strong lesion improvement (including EASI-75), and reduced injection burden. Henderson said Apogee has observed statistically significant itch relief within 48 hours and lesion responses he described as favorable versus other biologics, while positioning the maintenance dataset as the “last piece” needed to validate the company’s long-duration dosing thesis.
Dambkowski discussed the company’s trial design, saying patients on treatment were re-randomized to every-three- or six-month dosing. He said Apogee plans to evaluate maintenance by examining week-16 responders—such as EASI-75 or IGA 0/1 responders—and measuring how well they maintain response at week 52. He cited benchmarks from other products, stating Dupixent has shown 72% of EASI-75 responders maintaining response at week 52 and 53% of IGA 0/1 responders maintaining response, while Ebglyss was described as nominally higher on EASI-75 and somewhat higher on IGA 0/1.
On safety, Dambkowski said conjunctivitis is the main class-related adverse event expected, noting it tends to be most common during induction (through week 16), with lower frequency thereafter. He cited published rates in the range of 14% to 30% over 52 weeks for comparators. Henderson added that physicians “just don’t care about conjunctivitis” to the degree investors may assume, describing factors such as greater scrutiny of eye symptoms in modern trials and high baseline predisposition in the enrolled population. He said about 50% of patients in Apogee’s study had predisposing conditions, and he described many cases as short-lived and often not requiring prescription treatment. He also said the median duration was 29 days and disputed the notion that conjunctivitis would persist long-term due to pharmacokinetics, referencing a comparison in which Dupixent’s duration was cited as longer.
Part B dosing and fixed-dose combination approach
Henderson said Part B includes testing a lower dose, replicating the Part A mid dose, and evaluating a higher dose with approximately twice lebrikizumab exposure compared with the mid dose’s roughly 30% to 40% higher exposure. He said the goal is to determine whether incremental efficacy can be achieved at higher exposure levels, while noting that stronger efficacy beyond Part A would be “upside” if replication is achieved.
Executives also discussed potential future indications and label flexibility. Henderson referenced eosinophilic esophagitis (EoE) as an area of interest, noting that Dupixent is dosed weekly in EoE and that monthly dosing could represent a meaningful improvement, while cautioning further work would be needed.
Jane Henderson addressed two factors the company views as important across Type 2 biologics: injection-site reactions (ISRs) and anti-drug antibodies (ADAs). She said ISRs are a driver of discontinuation for Dupixent, and stated that in Apogee’s Part A, no ISRs were observed, while acknowledging some could occur in future studies. On ADAs, she said Apogee has seen around 10% ADAs with no observed impact to efficacy, contrasting that with reports that ADAs can affect efficacy for some biosimilars.
Commercial outlook, runway, and 2029 launch planning
Management said Apogee is developing APG279, a fixed-dose co-formulation combining IL-13 and OX40 ligand, which they described as being studied head-to-head versus Dupixent. Henderson positioned OX40 ligand and TSLP programs as combination partners rather than monotherapies, arguing the company’s goal is to establish zumilokibart as a frontline therapy and use combinations for patients needing additional efficacy in a second-line setting.
In discussing competitive dynamics, Henderson referenced reports of Kaposi’s sarcoma cases in trials of rocatinlimab and amlitelimab, while emphasizing that Apogee believes second-line options must demonstrate clear efficacy advantages to justify safety trade-offs. Hartness said he views Apogee as “the next first-line agent” and said the company aims to challenge Dupixent’s leading position in AD, citing rapid itch response, lesion control, and quarterly-or-better dosing as key differentiators. He said Apogee is planning for a 2029 launch.
Jane Henderson said Apogee has over $900 million in cash and expects runway into the second half of 2028, which she said would carry the company through Phase III top-line data from two replicate placebo-controlled trials. She also highlighted manufacturing planning, stating the company has optimized for a high-yield, high-titer process and expects “low single-digit” cost of goods sold (COGS). On commercialization, she said Apogee anticipates launching with a sales force similar in size to peers such as Galderma or Ebglyss, estimating about 150 representatives.
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 ROR?t, a master regulator of T cell-driven inflammatory pathways. By modulating ROR?t 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 ROR?t inverse agonist currently undergoing early-stage clinical evaluation for moderate to severe plaque psoriasis.
