BRE-AD01 / Brexogen, BMI Korea - LARVOL DELTA

First-in-Human Phase I Clinical Outcomes of BxC-I17e Enriched with HSP70/miR-22-3p in Atopic Dermatitis (EAACI 2026) - "Conclusion A single subcutaneous dose of BxC-I17e showed favorable safety and durable Week-8 improvements in patients with moderate-to-severe AD. Mechanistic and multi-omic data support a receptor-targeted, extracellular vesicle (EV)-based mechanism that suppresses Th2 signaling, providing a translational foundation for further clinical development in AD."

Clinical • Clinical data • First-in-human • P1 data • Atopic Dermatitis • Dermatitis • Immunology • IFNG • MIR22 • STAT6

Brexogen releases interim phase 1 data for exosome-based atopic dermatitis candidate 'BRE-AD01' (BioNews) - "According to the single-dose data presented at this conference, the candidate demonstrated favorable safety and tolerability across all dose groups. Notably, statistically significant improvements were observed over an eight-week period following a single administration in key efficacy endpoints, including the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and Bone Surface Area (BSA)....Brexogen added that conference participants expressed high expectations for the potential of BRE-AD01 as a differentiated new treatment option distinct from existing therapies."

P1 data • Atopic Dermatitis

Mechanistic and phase I clinical evaluation of HSP70/miR-22-3p-enriched IFN-γ–MSC-EVs for Th2 signaling suppression in atopic dermatitis (SID 2026) - "BxC-I17e reduced dermatitis severity scores by up to 75% in the DNCB model, demonstrating a greater reduction than upadacitinib under the tested conditions, and suppressed dermal inflammation, mast cell infiltration, and systemic Th2 cytokines. In the phase I trial, patients showed improvements in severity categories by week 8 (IGA severe 16.7%→0%; EASI severe 33.3%→16.7%; pruritus NRS severe 33.3%→0%) with favorable tolerability. Overall, BxC-I17e attenuated Th2 signaling via a receptor-targeted, multi-cargo mechanism involving HSP70 and miR-22-3p, supporting preclinical efficacy and early clinical translation for AD therapy."

Clinical • First-in-human • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • IFNG • MIR22 • STAT6

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Brexogen Inc. | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Brexogen, 2 projects selected for inter-ministerial regenerative medical technology development project [Google translation] (HIT News) - "Brexogen announced on the 8th that two research projects proposed by the company were finally selected as support targets for the '2025 Inter-Ministry Regenerative Medicine Technology Development Project'. With this project selection, Brexogen will receive 3.2 billion won of the total 4.3 billion won in research and development expenses from the government...For BxC-I17e, Brexogen has completed the ongoing Phase 1 clinical trial in the United States and aims to produce an investigational drug for Phase 2 clinical trial entry and apply for IND through this project."

Financing • New P2 trial • Trial status • Atopic Dermatitis

Brexogen-Korea BMI Signs 32 Billion Won Exosome Treatment L/O Deal [Google translation] (HIT News) - "Brexogen announced on the 19th that it signed a licensing agreement for the exosome-based treatment 'BxC-I17e' with Korea BMI...According to the company, BxC-I17e is an exosome-based treatment independently developed by Brexogen, and is currently undergoing clinical trials in the United States for the indication of atopic dermatitis...Korea BMI explained that it decided to transfer the technology after reviewing the preclinical data and confirming the possibility of expanding the indications of BxC-I17e. Through this contract, Korea BMI has secured the development and sales rights for indications other than atopy and immune diseases not only in Korea but also in major overseas markets....Brexogen will receive a non-refundable down payment of 3 billion won, and can receive up to 29 billion won in additional milestones based on future development, approval, and sales."

Licensing / partnership • Atopic Dermatitis

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Brexogen Inc. | N=27 ➔ 45 | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Brexogen Inc. | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Brexogen Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CCL22 • IL13 • IL22 • POSTN

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Brexogen Inc.

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

‘Exosome’ new drug development venture Brexogen attracts KRW 12 billion in Series C investment [Google translation] (HIT News) - "Brexogen...announced on the 1st that it succeeded in attracting 12 billion won worth of investment through a Series C round in the current cold investment climate in the capital market. This investment comes one year and eight months after the Series B investment was attracted in 2021, and the cumulative investment amounts to 32 billion won....The funds raised this time will be used to complete the phase 1 clinical trial of the first pipeline, atopic dermatitis exosome treatment (BRE-AD01), currently underway in the United States for patients with severe atopic dermatitis..."

Financing • Atopic Dermatitis • Immunology

Brexogen, ’exosome material’ atopy US phase 1 “first patient administration” [Google translataion] (Biospectator) - "Brexogen announced on the 4th that it started administering 'BRE-AD01', a candidate for exosome treatment, to the first patient in the US phase 1 clinical trial for atopic dermatitis. This clinical trial evaluates the safety, tolerability, and preliminary efficacy of BRE-AD01 by dose in 27 patients with moderate to severe atopic dermatitis aged 18 years or older in the United States. The clinical trial will be conducted at the University of Pennsylvania and Arkansas Research Trials."

Trial status • Atopic Dermatitis • Dermatology • Immunology