Exhibit 99.1
Viridian Therapeutics to Present Key 2024 Corporate Priorities at J.P. Morgan Healthcare Conference
- VRDN-001 topline clinical results for THRIVE and THRIVE-2 on track for mid-2024 and year-end 2024 in patients with active and chronic thyroid eye disease (TED), respectively -
- Subcutaneous VRDN-003 pivotal study in TED anticipated to start in mid-2024, pending alignment with regulatory authorities -
- Anti-neonatal Fc receptor (FcRn) portfolio progressing as planned with VRDN-006 IND anticipated by year-end 2024 and VRDN-008 data in non-human primates in 2H 2024 -
- Tom Ciulla, M.D., M.B.A. promoted to Chief Medical Officer to succeed Barrett Katz, M.D., M.B.A. -
WALTHAM, Mass.—January 8, 2024—Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that President and Chief Executive Officer, Steve Mahoney, will discuss the company’s progress at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.
As part of Viridian’s presentation at the J.P. Morgan Healthcare Conference, Mr. Mahoney will provide key updates on the company’s anti-insulin-like growth factor 1 receptor (IGF-1R) programs in thyroid eye disease (TED) and its programs targeting FcRn. Viridian aims to build a world-class portfolio in TED with a differentiated and fast-to-market lead asset in VRDN-001, which is delivered intravenously, and a potential best-in-class asset, VRDN-003, which is designed to be self-administered subcutaneously at home as an infrequent and low-volume injection. In addition to TED, the company is also developing a novel portfolio of FcRn inhibitors with VRDN-006, an Fc fragment, and VRDN-008, which is engineered to have an extended half-life with the goal to prolong immunoglobulin G (IgG) suppression.
“2024 is poised to be a year with major catalysts for Viridian as we advance VRDN-001 towards topline data in two global Phase 3 studies in active and chronic TED, expected by the middle and end of the year, respectively,” said Mr. Mahoney. “In addition, we were thrilled by the positive data that exceeded our expectations from our healthy volunteer studies in December 2023 that led to the selection of VRDN-003 as our potential best-in-class subcutaneous program. We plan to initiate the VRDN-003 pivotal program in mid-2024, pending alignment with regulatory authorities, as we aim to decrease the treatment burden on patients and their families living with TED. We are equally excited by the progress in our FcRn portfolio. We look forward to submitting an Investigational New Drug Application (IND) for VRDN-006 by the end of the year and providing additional details on VRDN-008 in the second half of the year.”
Thyroid Eye Disease Portfolio: VRDN-001 and VRDN-003
Intravenous VRDN-001
Viridian’s lead product candidate, VRDN-001, is a monoclonal antibody that acts as a full antagonist of IGF-1R, a clinically and commercially validated target for TED that has current US annual revenues close to $2 billion. Viridian is currently evaluating VRDN-001 in two global Phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose treatment arm of VRDN-001, dosed three weeks apart, to placebo. This five-dose VRDN-001 regimen features fewer infusions and a shorter time per infusion compared to the currently marketed IGF-1R inhibitor. The company expects to report THRIVE and THRIVE-2 data in the middle of 2024 and by year end 2024, respectively.
THRIVE and THRIVE-2 data will look to confirm the Phase 2 data Viridian reported throughout 2022 and 2023. In all dose cohorts of a Phase 2 clinical trial, intravenous VRDN-001 was shown to improve the signs and symptoms of TED at six weeks in patients with active and chronic disease after two infusions. VRDN-001 was also well-tolerated.