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Viridian Therapeutics Announces Presentations at Multiple Medical Meetings in September

- Presentations to cover clinical and preclinical data on pipeline candidates in Company’s thyroid eye disease program, including lead candidate VRDN-001 -

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that multiple abstracts featuring clinical and preclinical data on the Company’s pipeline candidates for the treatment of thyroid eye disease (TED) will be presented at the following medical meetings:

  • The 45th Annual Meeting of the European Thyroid Association (ETA) to be held September 9-12, 2023, in Milan, Italy
  • The 41st Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery (ESOPRS) to be held September 14-16, 2023, in Naples, Italy
  • The Annual Meeting of the American Thyroid Association (ATA) to be held September 27-October 1, 2023, in Washington, DC

Presentations at all three conferences will highlight clinical and pharmacologic data from studies of VRDN-001, a full antagonist antibody to the insulin-like growth factor-1 receptor (IGF-1R), in development for TED. An additional presentation will feature pharmacokinetic data for VRDN-003, a next-generation, half-life extended antibody to IGF-1R for TED. The Company will also present clinical pharmacodynamic responses to VRDN-001 in healthy volunteers and patients with active TED.

Conference: ETA

 

Title:

VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor: In Vitro Pharmacology and Phase 1/2 Results in Patients with Thyroid Eye Disease

Session:

Oral Session 9—Thyroid Eye Disease

Information:

Monday, September 11, 2023, 2:40 to 2:52 pm CET

 

Title:

Preclinical Pharmacokinetics and Clinical Exposure Prediction for VRDN-003, a Next-Generation Half-life Extended Antibody to IGF-1R for Thyroid Eye Disease

Session:

Oral Session 9—Thyroid Eye Disease

Information:

Monday, September 11, 2023, 2:52 to 3:04 pm CET

 

Conference: ESOPRS

 

Title:

In Vitro Pharmacology and Phase 1/2 Results of VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease

Session:

Oral Communications: Orbit

Information:

Friday, September 15, 2023, 2:20 to 2:25 pm CET

 

Title:

VRDN-001, a Full Antagonist Antibody to IGF-1R: Proof-of-Concept Results in Chronic TED

Session:

Oral Communications: Orbit/Socket

Information:

Saturday, September 16, 2023, 9:35 to 9:40 am CET

 

Conference: ATA

 

Title:

In Vitro Pharmacology and Phase 1/2 Results of VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease

Session:

Oral Abstracts Session 3: Effects and Treatment of Autoimmune TED

Information:

Thursday, September 28, 2023, 1:50 to 2:50 pm EDT

 

Title:

Pharmacodynamic Responses to VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in Development for Thyroid Eye Disease (TED) in Healthy Volunteers and Patients with Active TED

Session:

Poster Review

Information:

Thursday, September 28, 2023, 10:30 am to 6:00 pm EDT

Following their respective presentations, the above abstracts will be posted at www.viridiantherapeutics.com/pipeline/scientific-presentations.

About Viridian’s Thyroid Eye Disease Pipeline (VRDN-001, -002, and -003)

Viridian’s lead product candidate, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease (TED). In preclinical studies, VRDN-001 was shown to be a full antagonist of IGF-1R, with more complete receptor blockade than other anti-IGF-1R antibodies, including the only currently approved TED therapy. Data from the Phase 2 portion of the ongoing trial established clinical proof-of-concept for VRDN-001 in patients with active and chronic TED. VRDN-001 was generally well tolerated in the trial. The THRIVE Phase 3 trial in patients with active TED is ongoing. The Company is currently planning to start its second Phase 3 trial, called THRIVE-2, in patients with chronic TED.

The Company is also advancing three candidates (VRDN-001, VRDN-002, and VRDN-003 subcutaneous (SC)) designed for administration as convenient, low-volume, SC injections for the treatment of TED.

Viridian’s goal is to potentially bring a best-in-class intravenous therapy followed by a first- and best-in-class SC therapy to the market for the treatment of the TED.

VRDN-001, -002, and -003 are investigational therapies that are not approved for any use in any country.

About TED

TED is a serious and debilitating rare autoimmune disease that causes inflammation within the orbit of the eye that can cause double vision, pain, and potential blindness. TED is a progressive disease consisting of an initial active phase, followed by a transition to a secondary chronic phase. More than 50,000 and 200,000 people are estimated to suffer from active and chronic TED, respectively, in the United States and Europe.

About Viridian Therapeutics

Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.

Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company is conducting its first global Phase 3 trial called THRIVE to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is also planning a second Phase 3 trial, called THRIVE-2, to evaluate the safety and efficacy of VRDN-001 in patients with chronic TED. In addition to its program for intravenously administered VRDN-001, the Company is advancing three candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is also developing multiple preclinical assets in autoimmune and rare diseases.

Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and Twitter.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding our expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: the potential efficacy and safety of VRDN-001, VRDN-002, and VRDN-003 for the treatment of Thyroid Eye Disease (TED), the results of ongoing or future clinical trials; the timing, progress and plans for our ongoing or future research, pre-clinical and clinical development programs; including the clinical trials for VRDN-001, VRDN-002, and VRDN-003 and other risks and uncertainties, including those risks set forth under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2023 and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

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