Viridian completes subject enrolment for Phase III trial of TED treatment

The company is on schedule to present the topline readout from the THRIVE-2 trial by the end of the year.

Vishnu Priyan July 26 2024

Viridian Therapeutics has announced the completion of subject enrolment for its Phase III THRIVE-2 clinical trial of VRDN-001, aimed at treating patients with chronic thyroid eye disease (TED).

The trial enrolled a total of 188 patients worldwide, surpassing the initial target of 159 due to high patient interest.

Approximately 40% of participants were recruited from sites in the US.

The company is on schedule to present the topline readout from the THRIVE-2 by the end of the year.

Viridian earlier reported that its Phase III THRIVE trial for VRDN-001 in active TED completed enrolment in March with about half of the patients coming from the US.

The topline data from this trial is anticipated in September this year.

VRDN-001, the leading product candidate of the company, is a monoclonal antibody for intravenous administration that fully antagonises the insulin-like growth factor-1 receptor (IGF-1R). It is said to be a validated target for TED.

The product is said to have the ability to enhance the patient experience through a dosing regimen that requires shorter infusion times and fewer infusions compared to the existing approved IGF-1R inhibitor.

Viridian president and CEO Steve Mahoney said: “We are very pleased with our overall clinical trial enrolment for the VRDN-001 trials. THRIVE and THRIVE-2 have now each exceeded their enrolment targets and enrolled substantial patient numbers in the US due to patient demand.

“We look forward to our topline data readout for THRIVE in September and for THRIVE-2 at the end of this year. We are also on track to initiate two subcutaneous VRDN-003 phase 3 clinical trials, REVEAL-1 and REVEAL-2, in August as planned.”

Last month, the company announced plans to begin two Phase III clinical trials of the anti-IGF-1R antibody, VRDN-003, to treat moderate-to-severe TED.

Named REVEAL-1 and REVEAL-2, the trials aim to assess the efficacy and safety of the subcutaneous doses of VRDN-003 in people with both active and chronic TED, respectively.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close