APG990 / Apogee Therap - LARVOL DELTA

Apogee Therapeutics Announces Late-Breaker Presentation of 16-Week Data from Phase 2 APEX Trial of APG777 for Moderate-to-Severe Atopic Dermatitis at the Upcoming European Academy of Dermatology and Venereology (EADV) 2025 Congress (GlobeNewswire) - "The Company will also present multiple poster presentations....previously reported healthy volunteer data of APG990.'"

Clinical data • Late-breaking abstract • Atopic Dermatitis

APG990, a monoclonal antibody targeting OX40L, demonstrates safety and an extended half-life in healthy subjects (EADV 2025) - No abstract available

Clinical • TNFSF4

The Combination of APG777 (anti-IL-13) and APG990 (anti-OX40L) Provides Broad Suppression of Inflammatory Cytokines (EADV 2025) - No abstract available

IL13 • TNFSF4

An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Apogee Therapeutics, Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Combination of APG777 (Anti-IL-13) and APG990 (Anti-OX40L) Provides Broad Suppression of Inflammatory Cytokines (AAD 2025) - "These data suggest that the combination of APG777+APG990 is a promising approach for the treatment of chronic inflammatory disease."

IO biomarker • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CD4 • IL13 • TNFSF4 • TSLP

Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990) (GlobeNewswire) - P1 | N=40 | ACTRN12624000775516 | Sponsor: Apogee Therapeutics, Inc. | Apogee Therapeutics, Inc...today announced positive interim Phase 1 results from its first-in-human trial of APG990...APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. PK profile supports the potential for a single 2 mL coformulated injection of APG279 (APG777 + APG990) administered every three- and six- months. APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache. 53% of participants observed at least one TEAE. There were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills."

P1 data • Atopic Dermatitis • Immunology

Apogee Therapeutics to Host Conference Call to Report Interim Results from the Phase 1 Healthy Volunteer Trial for APG990 and Provide Combination Strategy Update on March 3, 2025 (GlobeNewswire) - "Apogee Therapeutics...announced it will report interim results from the Phase 1 APG990 healthy volunteer trial on Monday, March 3, 2025. Following the announcement, the Company will host a conference call and webcast at 8:30am ET to discuss the results and plans for its combination approach for APG777 + APG990."

P1 data • Pipeline update • Immunology

Apogee plans to advance development of APG777 in expansion indications… (GlobeNewswire) - "Apogee plans to advance development of APG777 in expansion indications by initiating a Phase 1b trial in asthma in the first half of 2025, followed by a Phase 2b trial in asthma in the second half of 2025, and launching a Phase 2 trial in EoE in 2026...Apogee plans to initiate its first combination study, a Phase 1b trial of APG777 and APG990, a novel, SQ, half-life extended mAb targeting OX40L, in 2025. This combination study is designed to evaluate the safety, PK, PD and efficacy against DUPIXENT in patients with moderate-to-severe AD, with readout expected in the second half of 2026."

New P1 trial • New P2 trial • New P2b trial • P1 data • Asthma • Atopic Dermatitis • Eosinophilic Esophagitis

A First-in-human Study of APG990 in Healthy Participants (ANZCTR) - P1 | N=40 | Recruiting | Sponsor: Apogee Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2024

Enrollment open • Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG990, its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases (GlobeNewswire) - "Apogee Therapeutics...announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting OX40L, which is being developed initially as a treatment for people living with AD....The APG990 Phase 1 clinical trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG990 and is expected to enroll approximately 40 healthy adults into 5 cohorts. Apogee expects interim data from the trial in 2025....The company plans to initiate the first clinical trial of the APG777 and APG990 combination in 2025."

New trial • P1 data • Trial status • Atopic Dermatitis • Inflammation

A First-in-human Study of APG990 in Healthy Participants (ANZCTR) - P1 | N=40 | Not yet recruiting | Sponsor: Apogee Therapeutics, Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Apogee Highlights Corporate Progress and Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "APG990 program progressing as a differentiated OX40L-targeted opportunity....Apogee expects to select a development candidate for its APG990 program in 2024. APG222 program advancing with a dual mechanism targeting both IL-13 and OX40L: APG222 is one or more SQ extended half-life mAbs targeting both IL-13 and OX40L, for the potential treatment of AD and other I&I indications. By blocking OX40L and IL-13, APG222 could simultaneously decrease OX40L signaling, helping to rebalance the immune system and decrease immune cell differentiation and cytokine release, and further reduce IL-13, resulting in even less immune signaling. This approach has the potential to prevent certain disease-related signs and symptoms that are driven by IL-13 signaling and the downstream inflammatory cascade."

Pipeline update • Preclinical • Atopic Dermatitis • Immunology