UPDATE – Viridian Therapeutics Announces Presentations at the 2023 Annual Meeting of the Association for Research in Vision and Ophthalmology

- Presentations to cover updated clinical and preclinical data on pipeline candidates in Company’s thyroid eye disease program -

- Platform presentation to feature data from ongoing Phase 1/2 trial of VRDN-001 -

- Poster presentations to feature new clinical and preclinical research on VRDN-002 and VRDN-003 -

WALTHAM, Mass., April 20, 2023 (GLOBE NEWSWIRE) -- 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 updates on the Company’s investigational therapies for the treatment of thyroid eye disease (TED)—including new preclinical research on VRDN-003—will be presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO 2023), to be held April 23-27, 2023, in New Orleans, Louisiana.

A platform session will feature the proof-of-concept results from the Phase 1/2 trial of VRDN-001 in patients with TED, while two posters will present new preclinical pharmacokinetic and bioavailability data on VRDN-002 as well as pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers treated with VRDN-002. Two additional poster presentations will highlight the design, characterization, and preclinical pharmacokinetics of VRDN-003. VRDN-002 and VRDN-003 are next-generation, half-life extended antibody antagonists to the insulin-like growth factor-1 receptor (IGF-1R), in development for TED.

Oral Presentation

Data from Viridian’s ongoing Phase 1/2 clinical trial of VRDN-001 will be highlighted in an oral presentation on Thursday, April 27, 2023, from 2:15 to 2:30 pm CDT, during a session entitled “Eye Movement Disorders.”

Poster Presentations

Title:	VRDN-002, a Next-Generation Half-life Extended Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease: Safety and Pharmacokinetic/Pharmacodynamic (PK/PD) Results in Healthy Volunteers
Session:	Thyroid eye disease and extraocular muscles
Information:	Wednesday, April 26, 2023, 10:30 am to 12:15 pm CDT, Poster #4038 - B0355

Title:	Preclinical Pharmacokinetics and Bioavailability of VRDN-002, a Next-Generation Half-Life Extended Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease
Session:	Thyroid eye disease and extraocular muscles
Information:	Wednesday, April 26, 2023, 10:30 am to 12:15 pm CDT, Poster #4039 - B0356

Title:	Preclinical Pharmacokinetics of VRDN-003, A Next-Generation Half-life Extended Antibody to the IGF-1 Receptor for Thyroid Eye Disease
Session:	Thyroid eye disease and extraocular muscles
Information:	Wednesday, April 26, 2023, 10:30 am to 12:15 pm CDT, Poster #4043 - B0360

Title:	Design and Preclinical Characterization of VRDN-003, a Next-Generation, Half-life Extended Antibody to IGF-1 Receptor in Development for Thyroid Eye Disease
Session:	Thyroid eye disease and extraocular muscles
Information:	Wednesday, April 26, 2023, 10:30 am to 12:15 pm CDT, Poster #4044 - B0361

Following their presentation at ARVO 2023, 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. Preliminary data from the initial dose cohorts of the Phase 2 portion of the ongoing trial established clinical proof-of-concept for VRDN-001 in patients with active TED: treatment with VRDN-001 led to clinically meaningful reductions in proptosis, improvement in clinical activity score (CAS), and diplopia resolution. VRDN-001 had a favorable safety profile and was well tolerated in the trial. The Company is running a Phase 3 trial, known as THRIVE, in patients with active TED.

VRDN-001 is also being evaluated in Phase 2 trial cohorts in patients with chronic TED. Pending the release of that data, the Company plans to initiate its THRIVE-2 Phase 3 trial in patients with chronic TED.

The Company is advancing VRDN-001, VRDN-002, and VRDN-003 as subcutaneous (SC) program candidates. All three candidates have the potential to be developed for self-administration by a convenient, SC pen device. VRDN-001 IV’s low-dose data support its potential as a SC candidate. VRDN-002 is a novel anti-IGF-1R monoclonal antibody incorporating half-life extension technology. VRDN-003 is an anti-IGF-1R monoclonal antibody with the same amino acid sequence as VRDN-001, except for the addition of the half-life extension technology that is incorporated in VRDN-002.

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 recently initiated 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 evaluating VRDN-001 in a Phase 2 proof-of-concept trial 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.

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 the Company’s expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding the Company’s expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s 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 TED, the timing progress and plans for the Company’s ongoing and future research and clinical development plans, trial protocols for ongoing or future clinical trials, including the clinical trials for VRDN-001, VRDN-002 and VRDN-003, including those risks set forth under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 11, 2022 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.

Contacts

Investors:
Louisa Stone, 508-808-2400
Manager, Investor Relations
IR@viridiantherapeutics.com

Todd James, 617-272-4691
Senior Vice President, Corporate Affairs and Investor Relations
IR@viridiantherapeutics.com

Media:
Matt Fearer, 617-272-4605
Vice President, Corporate Communications
Media@viridiantherapeutics.com

Source: Viridian Therapeutics, Inc.