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January 31, 2022

Viridian receives FDA consent to run Phase I thyroid eye disease trial

The first-in-human trial will evaluate the safety, pharmacokinetics, tolerability and pharmacodynamics of VRDN-002.

Viridian Therapeutics has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical trial of its antibody VRDN-002 to treat thyroid eye disease (TED).

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Viridian anticipates results from the trial in the middle of this year.

VRDN-002 is an insulin-like growth factor 1 receptor (IGF-1R) humanised monoclonal antibody.

It incorporates half-life extension technology to facilitate administration as a low-volume subcutaneous (SC) injection to treat TED.

The company had filed the IND application with the FDA for VRDN-002 in December last year.

The first-in-human, single ascending dose trial will analyse the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous doses of VRDN-002 in healthy subjects.

The company will provide information on the feasibility of a low-volume and/or low-frequency SC dosing regimen of the antibody in individuals with TED.

Viridian Therapeutics president and CEO Jonathan Violin said: “We believe the incorporation of half-life extension technology into VRDN-002 may enable a differentiated, low volume subcutaneous injection, offering TED patients improved convenience and broader settings of care. 

“This IND acceptance is the first of multiple regulatory, clinical, and operational milestones expected in 2022, including top-line data from our VRDN-001 Phase I/II proof of concept trial in the second quarter of 2022, and top-line data from our VRDN-002 Phase I trial in mid-2022.”

Apart from VRDN-002, the company has another differentiated targeting IGF-1R monoclonal antibody, VRDN-001.

A debilitating autoimmune disease, TED leads to inflammation and fibrosis within the orbit of the eye. This could cause double vision, pain and potentially blindness. 

Several remedial surgical procedures to the orbit, eye muscles and eyelids are frequently needed for individuals with severe disease.

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