– THRIVE-2 exceeded its recruitment target due to patient demand; 188 patients registered, approximately 40% from U. S. sites. USA. –
– THRIVE effects in patients with active PDD are on track for September 2024 –
– THRIVE-2 effects on track by the end of 2024 –
WALTHAM, Mass. , July 25, 2024–(BUSINESS WIRE)–Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on the discovery and progression of high-quality potential drugs for serious and rare diseases, announced that enrollment is complete for THRIVE-2, its Phase 3 clinical trial for VRDN-001 in patients with chronic PDD.
THRIVE-2 enrolled 188 patients worldwide and exceeded the recruitment goal of 159 patients due to patient demand. Approximately 40% of enrolled patients were from U. S. centers. Key data from THRIVE-2 are expected to be read through the end of 2024. Previously, Viridian announced that THRIVE, its Phase 3 clinical trial for VRDN-001 in patients with active PDD, had completed and surpassed enrollment by March 2024 with approximately 50% of patients enrolled at US sites. THRIVE key insights are expected to be read in September 2024.
“We are very pleased with the overall recruitment for the VRDN-001 clinical trials,” said Steve Mahoney, President and CEO of Viridian. “THRIVE and THRIVE-2 have now exceeded their recruitment goals and recruited a significant number of patients in the United States due to patient demand. We look forward to reading our key insights for THRIVE in September and for THRIVE-2 in late this year. We are also on track to initiate two Phase 3 subcutaneous clinical trials of VRDN-003, REVEAL-1 and REVEAL-2, in August, as planned.
About VRDN-001
Viridian’s lead product candidate, VRDN-001, is an intravenously (IV) administered monoclonal antibody that acts as a complete insulin-like expansion factor 1 (IGF-1R) receptor antagonist. IGF-1R is a clinically and commercially validated target for thyroid eye disease (TED) that has generated revenue in the U. S. UU. de approximately $1. 8 billion in 2023. VRDN-001 has the potential to delight patients through a differentiated dosing regimen that includes a shorter infusion time and fewer infusions compared to the recently approved and publicized IGF-1R inhibitor.
Viridian is comparing VRDN-001 in two global Phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic PDD, respectively. THRIVE and THRIVE-2 are designed to compare a treatment arm with five doses of VRDN-001 to placebo, each administered 3 weeks apart. In phase 2 clinical trials in active and chronic PDD, VRDN-001 was shown to improve symptoms and symptoms of PDD six weeks after two infusions in all dose cohorts and was sometimes good. Tolerated.
Viridian believes that differentiated VRDN-001 has a chance of gaining a strong position in the multibillion-dollar TED advertising market, if approved, and will facilitate the arrival of VRDN-003, its most productive prospective subcutaneous IGF. of its category. -1R antibody for TED.
About Viridian Therapeutics
Viridian is a biopharmaceutical company focused on engineering and creating world-class prospective medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the progression of differentiated cure candidates for past validated drug targets in the commercial arena. established disease areas.
Viridian offers several in-clinic candidates for the treatment of patients with thyroid eye disease (PDD). The company is conducting a pivotal program for VRDN-001, adding two global Phase 3 clinical trials (THRIVE and THRIVE-2), to compare its efficacy and protection in patients with active and chronic PDD. Viridian is also advancing VRDN-003 as a potential first-in-class subcutaneous remedy for the treatment of PDD, adding two planned global Phase 3 clinical trials, REVEAL-1 and REVEAL-2. , to compare the efficacy and protection of VRDN-003 in patients with active and chronic PDD.
In addition to its TED portfolio, Viridian is introducing a new portfolio of neonatal Fc receptor inhibitors (FcRn), adding VRDN-006 and VRDN-008, which should evolve into several autoimmune diseases.
Viridian is founded in Waltham, Massachusetts. For more information, visit www. viridiantherapeutics. com. Follow Viridian on LinkedIn and X.
Forward-looking statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be known by the use of words such as, but not limited to, “anticipate,” “believe,” “continue. ” “, “may”, “estimate”, “expect”, “intend”, “could”, “could”, “plan”, “prospective”, “predict”, “project”, “should”, “target”, “will”, or “would” or other similar terms or expressions that relate to our expectations, plans and intentions. Forward-looking statements are neither past facts nor promises of long-term performance. Rather, they are based on our existing beliefs, expectations, and assumptions. Forward-looking statements include, but are not limited to, statements relating to: clinical systems and clinical progression of Viridian product applicants; and examine the design, adding the REVEAL-1 and REVEAL-2 clinical trials; upcoming milestones and expected knowledge readings and effects and the timing of such readings, adding primary readings and effects; that VRDN-001 has the potential for patient enjoyment through a differentiated dosing regimen that has a shorter infusion time and fewer infusions compared to the currently approved and advertised IGF-1R inhibitor; that the differentiated VRDN-001 has the potential to firmly establish itself in the multibillion-dollar TED advertising market, if approved, and will help facilitate the arrival of VRDN-003, its best-in-class subprospective skin antibody, for TED; planned frequency of administration; the possible usefulness, efficacy, potency, safety, clinical benefits, clinical reaction and appropriateness of VRDN-001, VRDN-003, VRDN-006 and VRDN-008; the prospect of creating a portfolio of neonatal Fc receptor (FcRn) inhibitors in multiple autoimmune diseases; and Viridian product applicants are potentially best in class.
New dangers and uncertainties may arise from time to time, and it is not imaginable to expect all dangers and uncertainties. No representation or warranty (express or implied) is made as to the accuracy of any such forward-looking statements. These forward-looking statements are subject to a number of important hazards and uncertainties, including, but not limited to: the potential usefulness, efficacy, potency, safety, clinical benefits, clinical reaction and suitability of Viridian’s product candidates; the dating between the positive effects of knowledge of completed or ongoing clinical trials and the effects of ongoing or long-term clinical trials; that initial knowledge would possibly not be representative of ultimate knowledge; the timing, progress and plans of our existing or long-term research, preclinical and clinical progression programs; trial protocols for ongoing clinical trials; expectations related to the timing of regulatory filings; regulatory interactions; expectations related to enrollment timing and awareness; prospective uncertainty and similar delays to clinical drug progression; the duration and effect of regulatory delays on our clinical programs; the timing and our ability to discharge and maintain regulatory approvals for our cure candidates; production hazards; festival of other treatments or products; market length estimates; Viridian’s position on intellectual property; the timing of clinical and preclinical trial activities and the reporting of their effects; and the dangers set forth under the heading “Risk Factors” in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2024 and in other upcoming disclosure documents filed with the SEC. Any forecast refers only to the date on which it is made. Neither the Company nor its affiliates, advisors or representatives undertake any legal responsibility to publicly update or revise any forward-looking matrix, whether as a result of new information, long-term developments or otherwise, unless required by law. ‘requested. These forward-looking statements should not be relied upon to represent the Company’s prospects as of any date subsequent to the date hereof.
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Contacts
Louisa Stone, 617-272-4604 Manager, investisseursIR@viridiantherapeutics. com Relationships