Viridian Therapeutics Announces Presentations at the 49th Annual Meeting of the North American Neuro-Ophthalmology Society

- Data from ongoing Phase 1/2 trial of VRDN-001 to be presented during oral platform session -

- Additional poster presentations to cover trial design, early-stage clinical and mechanistic data on pipeline candidates in Company’s thyroid eye disease program -

WALTHAM, Mass., March 07, 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 on VRDN-001 and VRDN-002—the Company’s investigational therapies for the treatment of thyroid eye disease (TED)—will be presented at the 49^th Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS), to be held March 11 to 16, 2023, in Orlando, Florida.

An oral presentation with data from the ongoing Phase 1/2 trial of VRDN-001, a full antagonist antibody to the insulin-like growth factor 1 receptor (IGF-1R), is scheduled for the morning of Tuesday, March 14, with four posters from Viridian’s TED program to be presented that evening.

“We are pleased to present this encouraging data from our TED pipeline at this important annual gathering,” said Barrett Katz, M.D., M.B.A., Chief Medical Officer of Viridian. “Taken together, the clinical and mechanistic data we are sharing at NANOS strengthen our confidence not only in VRDN-001 as we work to enroll patients in our active THRIVE Phase 3 trial, but also in our ability to develop follow-on assets with the potential for subcutaneous self-administration to decrease treatment burdens on patients and their families living with TED.”

Oral Presentation

Title:	VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED): Phase 1/2 Clinical Study in Patients
Session:	Platform Session II
Date:	Tuesday, March 14, 2023
Time:	7:30 a.m. to 7:45 a.m. EST

Poster Presentations

Title:	VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in Development for Thyroid Eye Disease (TED): Interim Phase 1/2 Pharmacodynamic Results
Session:	Meet the Poster Author: Analytical Studies
Poster:	#298
Date & Time:	Tuesday, March 14, 6:00 p.m. to 8:30 p.m.

Title:	THRIVE: A Phase 3 Trial of VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED)
Session:	Meet the Poster Author: Analytical Studies
Poster:	#296
Date & Time:	Tuesday, March 14, 6:00 p.m. to 8:30 p.m.

Title:	VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor in Development for Thyroid Eye Disease (TED), Binds to a Distinct Epitope from Teprotumumab
Session:	Meet the Poster Author: Analytical Studies
Poster:	#297
Date & Time:	Tuesday, March 14, 6:00 p.m. to 8:30 p.m.

Title:	VRDN-002, a Next-Generation Novel Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED): Results of a Phase 1 Trial
Session:	Meet the Poster Author: Analytical Studies
Poster:	#299
Date & Time:	Tuesday, March 14, 6:00 p.m. to 8:30 p.m.

Following their presentation, 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 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. Preliminary data from the ongoing trial showed 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 recently initiated its THRIVE Phase 3 trial in patients with active TED to support a global marketing registration.

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-002, a distinct anti-IGF-1R antibody incorporating half-life extension technology, and VRDN-003, a half-life extended version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for administration as convenient, low-volume, subcutaneous injections.

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 intravenously administered VRDN-001 program, the Company is advancing two candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is 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.