Thyroid Eye Disease Programs - Viridian Therapeutics, Inc.

Viridian is currently investigating a portfolio of potentially transformative anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibodies for the treatment of thyroid eye disease (TED). IGF-1R, a transmembrane receptor that plays a role in development, metabolism, and immune regulation, is a clinically and commercially validated target for the treatment of TED. Based on work in the field, IGF-1R and the co-located thyroid stimulating hormone receptor (TSHR) have been found to play a key role in the pathogenesis of TED. Viridian is making meaningful progress advancing potentially improved anti-IGF-1R antibodies for people affected by TED and expects its intravenous (IV) and subcutaneous (SC) programs to be transformative treatment options for patients.

	Approved Anti-IGF-1R Antibody	VRDN-001 IV	VRDN-003 SC
Administration	Intravenous Infusion	Intravenous Infusion	Self-administered Subcutaneous Injection
Mechanism	Partial Antagonist	Full Antagonist	Full Antagonist
Phase of Development	Approved	Phase 3	Phase 1 (Pivotal program anticipated to initiate in mid-2024)
Treatment Regimen	8 infusions, given three weeks apart with 60 to 90 minute infusion time	5 infusions, given three weeks apart with 30 minute infusion time	Potential for dosing every eight, four, or two weeks

TED Program Details

Viridian’s lead product candidate, VRDN-001, is a potential best-in-class, IV monoclonal antibody targeting IGF-1R. VRDN-001 acts as a full antagonist of IGF-1R, and based on clinical data to date, has demonstrated robust clinical activity and was generally well-tolerated at Week 6 compared with the currently approved anti-IGF-1R antibody.¹

The company is running two global Phase 3 trials, THRIVE (NCT05176639) and THRIVE-2 (NCT06021054), for people living with active and chronic TED, respectively.

¹ Conclusions are not based on head-to-head clinical trial results.

VRDN-001 IV

Featured Trials

THRIVE

Active Thyroid Eye Disease

Recruiting

Global Phase 3 trial to evaluate the efficacy and safety of VRDN-001 in patients with active TED

THRIVE-2

Chronic Thyroid Eye Disease

Recruiting

Global Phase 3 trial to evaluate the efficacy and safety of VRDN-001 in patients with chronic TED

VRDN-003 is a potential best-in-class subcutaneous anti-IGF-1R program in development for TED. VRDN-003 has the same binding domain as its parent molecule, VRDN-001, and was engineered to have a longer half-life. VRDN-003 is designed to maintain the clinical response of VRDN-001 IV while significantly increasing patient convenience and potentially improving safety.

The company expects to initiate a pivotal program for VRDN-003 in mid-2024 pending alignment with regulatory authorities.

VRDN-003 SC

TED Program Quote

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It is a walk that only those that have experienced TED know the extensive damage it can cause. This goes beyond our eyes… it goes much more deeper… it affects our self-esteem. We can't even recognize ourselves… it is like our identity has been reinvented.
Person living with TED (diagnosed in 2021)
When I was diagnosed with thyroid eye disease, there were very few patient centered resources out there, and there were also a very few treatment options. And we have to do something to progress the community forward.
Person living with TED (diagnosed in 2019)
A [treatment] would mean no more TED symptoms, normal looking eyes and eyesight and a normal shaped face. A [treatment] would be stable eyes and eyesight. Living a full life instead of a life hidden or in the dark.
Person living with TED (diagnosed in 2020)

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