FB-102 / argenx - LARVOL DELTA

A Study Testing the Safety and Effects of FB102 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

argenx Completes Acquisition of Forte Biosciences, Inc. (GlobeNewswire) - "The acquisition expands argenx’s portfolio of differentiated immunology medicines, adding FB102, a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease and potential to address multiple autoimmune diseases. The acquisition reflects argenx’s disciplined approach to identifying and advancing breakthrough science for patients with the potential to redefine standards of care in diseases that have lacked meaningful innovation for decades."

M&A • Celiac Disease • Immunology • Vitiligo

Argenx…announced that the companies have entered into a definitive agreement under which argenx will acquire Forte Biosciences for $77 per share in cash, representing a total equity value of approximately $2.2 billion. (Businesswire) - "FB102, Forte Biosciences’ lead program, expands argenx’s portfolio of differentiated immunology medicines, adding a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease and potential to address multiple autoimmune diseases."

M&A • Celiac Disease • Vitiligo

A Study Testing the Safety and Effects of FB102 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P1 trial

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Aug 2026 ➔ Mar 2027

Enrollment open • Trial primary completion date • Alopecia • Dermatology • Immunology

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Forte Biosciences, Inc. | N=16 ➔ 64 | Trial completion date: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Dermatology • Immunology • Vitiligo

Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Forte Biosciences, Inc. | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Celiac Disease • Immunology

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after multiple dose administration in participants with celiac disease. (ANZCTR) - P1 | N=32 | Active, not recruiting | Sponsor: Forte Biosciences, Australia Pty Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology • Inflammation

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P1 trial • Alopecia • Dermatology • Immunology

Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FB102 IN ADULT WITH CELIAC DISEASE (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P2 trial • Celiac Disease • Immunology

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Forte Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Vitiligo

A Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-segmental Vitiligo (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Forte Biosciences, Inc.

New P1 trial • Dermatology • Immunology • Vitiligo

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants (ANZCTR) - P1 | N=80 | Completed | Sponsor: Forte Biosciences Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Immunology • Inflammation

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after multiple dose administration in participants with celiac disease. (ANZCTR) - P1 | N=32 | Not yet recruiting | Sponsor: Forte Biosciences, Australia Pty Ltd

New P1 trial • Celiac Disease • Immunology • Inflammation

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants (ANZCTR) - P1 | N=80 | Recruiting | Sponsor: Forte Biosciences Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023

Enrollment open • Trial initiation date • Immunology • Inflammation

A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants (ANZCTR) - P1 | N=80 | Not yet recruiting | Sponsor: Forte Biosciences Australia Pty Ltd

New P1 trial • Immunology • Inflammation

Forte Biosciences, Inc. Announces $25 Million Financing and R&D Update for FB-102 (Businesswire) - "Forte Biosciences...today announced key R&D updates for FB-102 and the closing of financing to support the advancement of FB-102....We plan to advance FB-102 into the clinic in 2024....In a validated preclinical model of aggressive acute GvHD using transplanted human donor PBMCs, FB-102 reported 90% survival versus 0% survival on vehicle control and compared to 60% survival on ruxolitinib. In combination with ruxolitinib, the only FDA-approved treatment for acute GvHD, FB-102 reported 90% survival compared to 0% survival on vehicle control and 30% survival for ruxolitinib alone with extended duration of dosing compared to the single agent study."

Financing • New trial • Preclinical • Acute Graft versus Host Disease • Graft versus Host Disease