– Clinical and in vitro knowledge introduced in three late-breaking displays at ATA present rising proof of VRDN-001 efficacy and differentiation –
– Full 10 mg/kg cohort knowledge introduced at ATA, 20 mg/kg and three mg/kg cohort knowledge on monitor for 4Q22 –
– Pivotal program for VRDN-001 in TED sufferers set to start this quarter –
WALTHAM, Mass., Oct. 22, 2022 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology firm advancing new therapies for sufferers struggling from severe ailments underserved by present therapies, introduced optimistic proof-of-concept knowledge from the ten mg/kg cohort in its ongoing Phase 1/2 scientific trial of VRDN-001, an anti-IGF-1R antibody, in sufferers with lively thyroid eye illness (TED). These knowledge, in addition to new in vitro knowledge additional characterizing and differentiating the pharmacological profile of VRDN-001, had been included as a part of three late-breaking poster displays on the American Thyroid Association (ATA) 91st Annual Meeting. The summary describing new in vitro knowledge on the distinct anti-IGF-1R profile of VRDN-001 was additionally chosen as an oral highlighted late breaking presentation. The three posters can be found on the Viridian web site (click on right here).
“Patients suffering from TED would benefit from additional therapeutic options,” mentioned Raymond Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center and an investigator within the VRDN-001 trial. “The rapid and near complete resolution of key signs and symptoms of TED in the majority of patients at six weeks following two infusions of 10 mg/kg VRDN-001 in a cohort of patients with active TED suggests VRDN-001, with further study, may provide an important new option for TED patients.”
ATA Poster #535: VRDN-001, a Full Antagonist Antibody to the Insulin-Like Growth Factor Receptor-1 (IGF-1R) for Thyroid Eye Disease (TED): Phase 1/2 Proof of Concept in Patients with TED
Poster #535 presents proof-of-concept knowledge from the primary cohort of sufferers with lively TED handled within the ongoing Phase 1/2 scientific trial. In this cohort, a complete of 8 sufferers had been randomized to obtain two infusions of 10 mg/kg dose of VRDN-001 or placebo intravenously; 6 sufferers obtained VRDN-001 and a pair of sufferers obtained placebo. In sufferers receiving VRDN-001, proptosis response was achieved by 83% of sufferers, with a imply discount of two.4 mm from baseline. Clinical Activity Score (CAS) of 0 or 1 was achieved by 83% of sufferers, with a imply discount of 4.3 factors from baseline. Complete decision of diplopia was achieved by 75% of sufferers who introduced with diplopia at baseline. VRDN-001 demonstrated a good security and tolerability profile with no reported SAEs, no hyperglycemia, and no infusion reactions.
Poster #535 was authored by Shoaib Ugradar, UCLA Stein Eye Institute, Barrett Katz, Viridian Therapeutics, Denis O’Shaughnessy, Viridian Therapeutics, Rochelle Summerfelt, Viridian Therapeutics, Angela She, Viridian Therapeutics, and Raymond Douglas, Cedars Sinai Medical Center.
ATA Poster #568: VRDN-001, A Potent and Selective Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody for Thyroid Eye Disease (TED): Phase 1 Safety and Pharmacodynamic Results in Healthy Volunteers
Poster #568 presents full security and pharmacodynamic knowledge from the finished wholesome volunteer portion of the continuing Phase 1/2 trial of VRDN-001. A complete of 13 topics had been randomized to obtain two infusions of both 3, 10, or 20 mg/kg dose of VRDN-001 or placebo. Twelve topics accomplished the trial; one of many topics within the 20 mg/kg group withdrew for private causes after the primary infusion and was adopted by Day 35.
Plasma ranges of IGF-1, a biomarker for IGF-1R antagonism, elevated five- to seven-fold above baseline indicating maximal goal engagement in any respect doses. All doses studied had been usually protected and nicely tolerated, with no instances of listening to impairment or remedy associated hyperglycemia and no infusion reactions.
Poster #568 was authored by Angela She, Barrett Katz, Rochelle Summerfelt, Denis O’Shaughnessy, Brent Dickinson, Kelly Foster, and Vahe Bedian of Viridian Therapeutics
ATA Poster #132: VRDN-001, a Full Antagonist Antibody to the Insulin-Like Growth Factor-1 Receptor (IGF-1R) in Development for Thyroid Eye Disease (TED), Binds to a Distinct Epitope from Teprotumumab
Poster #132 presents preclinical knowledge from in vitro research of VRDN-001.The knowledge present that VRDN-001 binds the identical area of the IGF-1R as teprotumumab however engages a definite epitope. This distinction in binding translated to variations in useful results: in contrast to the anti-IGF-1R antibody teprotumumab, which incompletely antagonized IGF-1R perform, VRDN-001 totally antagonized ligand binding, receptor autophosphorylation, and downstream signaling.
These pharmacological variations might present a mechanistic foundation for the preliminary knowledge reported from the continuing VRDN-001 Phase 1/2 examine, together with the pharmacodynamic responses within the wholesome volunteer cohort introduced in Poster #568 and favorable scientific responses seen in TED sufferers as introduced in Poster #535.
Poster #132 was authored by Yang Zhao, Jordan Tsai, Rachel Newell, and Vahe Bedian of Viridian Therapeutics.
Upcoming Clinical Milestones for the Ongoing VRDN-001 Phase 1/2 Proof-of-Concept Trial
The Company stays on monitor to current further updates from the VRDN-001 Phase 1/2 examine this quarter. These updates will embody top-line knowledge for the 20 mg/kg cohort of the continuing Phase 1/2 trial of VRDN-001 in TED, adopted later this quarter by top-line knowledge from the at present enrolling 3 mg/kg cohort.
This ongoing trial is evaluating two infusions of VRDN-001, three weeks aside, with efficacy measured six weeks after the primary dose. Each dose is evaluated in a cohort of eight sufferers, randomized in order that six sufferers obtain VRDN-001 and two sufferers obtain placebo. The first cohort evaluated a dose of 10 mg/kg, with preliminary scientific knowledge reported on August 15, 2022. The Company expects to provoke the pivotal program for VRDN-001 by the top of 2022.
This quarter the Company additionally will report ultimate pharmacokinetic and pharmacodynamic knowledge from Viridian’s first-in-human trial of VRDN-002, a half-life prolonged IGF-1R antibody, which construct upon the lately introduced interim outcomes. The Company expects knowledge from a proof-of-concept trial of subcutaneously administered VRDN-002 within the second half of 2023.
About Viridian Therapeutics, Inc.
Viridian Therapeutics is a biotechnology firm advancing new therapies for sufferers struggling from severe ailments underserved by present therapies. Viridian’s most superior program, VRDN-001, is a differentiated monoclonal antibody concentrating on insulin-like development factor-1 receptor (IGF-1R), a clinically and commercially validated goal for the remedy of thyroid eye illness (TED). VRDN-002 is a definite anti-IGF-1R antibody and incorporates half-life extension know-how. VRDN-003 is an prolonged half-life model of VRDN-001. Both VRDN-002 and VRDN-003 are designed for administration as handy, low-volume, subcutaneous injections. TED is a debilitating autoimmune illness that causes irritation and fibrosis throughout the orbit of the attention which might trigger double imaginative and prescient, ache, and potential blindness. Viridian is predicated in Waltham, Massachusetts.
Note Regarding Forward-Looking Statements
This press launch comprises forward-looking statements throughout the that means of the Private Securities Litigation Reform Act of 1995. These statements could also be recognized by means of phrases corresponding to, however not restricted to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or different comparable phrases or expressions that concern the Company’s expectations, plans and intentions. Forward-looking statements embody, with out limitation, statements relating to the Company’s expectations, methods, plans and intentions. Forward-looking statements are neither historic info nor assurances of future efficiency. Instead, they’re based mostly on the Company’s present beliefs, expectations, and assumptions. New dangers and uncertainties might emerge from time to time, and it isn’t potential to foretell all dangers and uncertainties. No representations or warranties (expressed or implied) are made concerning the accuracy of any such forward-looking statements. Such forward-looking statements are topic to numerous materials dangers and uncertainties together with however not restricted to: the potential efficacy and security of VRDN-001 and VRDN-002 or the remedy of TED; the timing, progress and plans for the Company’s ongoing and future analysis and scientific improvement packages; expectations relating to the timing for knowledge, together with the anticipated timing of further knowledge from the continuing Phase 1/2 scientific trial of VRDN-001 and the first-in-human Phase 1 scientific trial of VRDN-002, together with these dangers set forth beneath the caption “Risk Factors” within the Company’s Annual Report on Form 10-Ok filed with the Securities and Exchange Commission (SEC) on March 11, 2022 and different subsequent disclosure paperwork filed with the SEC. Any forward-looking assertion speaks solely as of the date on which it was made. Neither the Company, nor its associates, advisors, or representatives, undertake any obligation to publicly replace or revise any forward-looking assertion, whether or not because of new data, future occasions or in any other case, besides as required by regulation. These forward-looking statements shouldn’t be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
Investor & Media Contact:
John Jordan
Viridian Therapeutics
Vice President, Investor Relations and Corporate Communications
617-272-4691
[email protected]
