Apogee Therapeutics Maps Phase 3 Push for Zumilokibart, Backed by Blackstone Funding

Key Points

• Apogee Therapeutics plans to start Phase 3 trials of zumilokibart in moderate-to-severe atopic dermatitis in the second half of the year, following Phase 2 data it says showed strong efficacy on itch and lesion endpoints with relatively infrequent dosing.
• The company is also expanding the IL-13 antibody into asthma and eosinophilic esophagitis, while exploring combination programs that could broaden its respiratory and inflammatory disease pipeline.
• Apogee said a recent Blackstone Life Sciences financing gives it up to $1.3 billion in capital, which it expects to fund development and commercialization through a potential 2029 launch and support strategic flexibility.

Apogee Therapeutics NASDAQ: APGE executives outlined plans to advance zumilokibart, the company’s IL-13-targeting antibody, into late-stage development for atopic dermatitis while expanding the program into asthma and eosinophilic esophagitis, during a Goldman Sachs discussion hosted by lead biotechnology equity research analyst Salveen Richter.

The company said its top priority remains moderate-to-severe atopic dermatitis, which Apogee described as the largest, fastest-growing and least-penetrated immunology and inflammation indication in its target markets. Executives said recent Phase 2 data support zumilokibart’s potential as a first-line product in atopic dermatitis, with a target launch by the end of the decade.

Apogee said Phase 2 Part B induction data showed “robust efficacy” across lesion and itch endpoints with four dosing dates, compared with nine for the current standard of care. Earlier Phase 2 Part A maintenance data showed responses continued to improve through 52 weeks, including an EASI-100 rate of more than 40% among patients in the maintenance setting, according to the company.

Phase 3 Atopic Dermatitis Program Set to Begin

Apogee said it plans to begin Phase 3 trials for zumilokibart in atopic dermatitis in the second half of the year. The program is expected to follow a standard design for the indication, including two replicate trials of about 400 patients each comparing zumilokibart with placebo, as well as a third trial in combination with topical corticosteroids to support labeling.

Executives said the Phase 2 Part B study was designed to replicate the strong results seen in Part A and to optimize dosing. The company said the mid-dose confirmed the product profile, while testing higher and lower doses helped determine whether additional efficacy could be achieved or whether lower dosing would be insufficient.

Jeff Hartness, Apogee’s chief commercial officer, said the company expects both every-three-month and every-six-month dosing to be included on the label. He said market research indicates physicians want dosing optionality and that some may initially use every-three-month dosing before transitioning patients to every-six-month dosing.

Hartness also emphasized the product’s itch profile, saying zumilokibart could allow physicians to manage both itch and lesions rather than choosing between the two. He compared the company’s itch data favorably with marketed therapies discussed during the session, including NEMLUVIO and JAK inhibitors.

Company Sees Large Market Opportunity

Hartness said Apogee views zumilokibart as the “next first-line launch” in atopic dermatitis and described the market as one that could grow to $50 billion. He said biologic penetration is currently about 10%, leaving room for growth as additional therapies expand the market.

He said zumilokibart’s dosing schedule could be a key differentiator, with two to four dosing days per year versus 26 dosing days per year for DUPIXENT. Hartness also said recent product launches, including Ebglyss and NEMLUVIO, are expanding the market and that future oral agents could help move more patients from topical therapies to systemic treatment.

On market access, Hartness said Apogee’s strategy is to secure early frontline access and that the company has already begun discussions with payers. He said recent branded launches with limited differentiation from DUPIXENT have obtained frontline access, and he expects zumilokibart to do the same.

Hartness also said he does not expect potential DUPIXENT biosimilars, which could enter the market as early as 2031, to negatively affect access for zumilokibart. He said biosimilar competition typically affects the reference product directly rather than surrounding branded biologics.

Blackstone Financing Supports Commercial Plans

Apogee executives also discussed the company’s recently announced collaboration with Blackstone Life Sciences, describing it as a non-dilutive financing designed to support development and commercialization. The company said the transaction includes access to up to $1.3 billion in capital, consisting of $800 million of royalty financing flexibility and up to $500 million of debt.

Executives said the financing, together with the company’s balance sheet, is expected to take Apogee through commercialization of zumilokibart in 2029 and potentially to profitability. The company said it focused on three priorities in the transaction: the amount of capital, cost of capital and strategic flexibility.

Apogee said the agreement does not include milestone payments back to Blackstone and includes royalty rates that scale down as sales grow. Executives also said a future strategic acquirer would have the option to buy down the royalty to a low-single-digit rate, which the company said was designed to preserve flexibility in a change-of-control scenario.

Pipeline Expansion in Asthma, EoE and Combination Programs

Beyond atopic dermatitis, Apogee said it plans to start a Phase 2 trial in eosinophilic esophagitis in the second half of the year. The open-label study is expected to enroll 30 to 50 patients, with histology measured by eosinophil count as the primary endpoint. Executives said the study will also evaluate patient diaries and endoscopy.

The company also plans a Phase 2b study in moderate-to-severe asthma that it said could potentially be registrational. Apogee said the 500-patient trial will enrich for patients with eosinophils above 150 and a history of exacerbations, and will test three-month, six-month and 12-month dosing schedules. The company cited earlier data showing durable FeNO suppression out to eight months.

Apogee also highlighted two combination programs. Data for APG279, a coformulation targeting IL-13 and OX40 ligand, are expected in the second half of the year in a head-to-head study against DUPIXENT. The company said the bar for advancement is high and that it would not move the program forward unless it shows meaningful added efficacy over zumilokibart alone.

For APG273, which combines IL-13 and TSLP targeting, Apogee said it plans to disclose more details in the second half of the year. Executives said the combination could offer broader patient reach and potential efficacy advantages in respiratory indications, including asthma and COPD.

Apogee said its main objective is to bring zumilokibart to as many patients as possible as quickly as possible. Executives said the company now has the capital to advance the program independently, while noting that as a public company it would listen if a strategic party could demonstrate it could accelerate access to patients at a lower cost of capital.

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.

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