VRDN-002 / Viridian Therap - LARVOL DELTA

Emerging therapies in the medical management of thyroid eye disease. (PubMed, Front Ophthalmol (Lausanne)) - "Teprotumumab - an anti-IGF-1R monoclonal antibody that has recently emerged as a first-line therapy for active, moderate-to-severe TED - has demonstrated statistically significant improvements in proptosis, diplopia, clinical activity score, and quality of life compared to placebo. Currently under investigation are several other agents, with varying administration modalities, that aim to inhibit IGF-1R: VRDN-001 (intravenous), VRDN-002 or VRDN-003 (subcutaneous), lonigutamab (subcutaneous), and linsitinib (oral). Tocilizumab, a monoclonal antibody of interleukin 6, has played a role in the management of multiple autoimmune and inflammatory conditions and may offer promise in TED...Among the agents under investigation that aim to decrease ocular morbidity associated with TED are agents that IGF-1R, interleukin 6, and the neonatal Fc receptor. The management of TED continues to expand with novel immunologic approaches for disease therapy."

Journal • Review • Endocrine Disorders • Grave’s Disease • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • IL6

VRDN-002, a Next-Generation Half-life Extended Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED): Safety and Pharmacokinetic/Pharmacodynamic (PK/PD) Results in Healthy Volunteers (ARVO 2023) - "Our study in healthy adults showed that VRDN-002 was well tolerated and can achieve similar activity in the body with lower doses, allowing for more convenient at home treatments than the currently approved therapy typically given at a clinic. If proven to be safe and effective, VRDN-002 could become a more convenient, self-administered treatment option for TED patients."

Clinical • PK/PD data • Ocular Inflammation • Ophthalmology • IGF1

Preclinical Pharmacokinetics and Bioavailability of VRDN-002, a Next-Generation Half-Life Extended Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED) (ARVO 2023) - "VRDN-002 has the potential to achieve similar activity in the body with more convenient at-home treatments than the currently approved therapy provided at a clinic. If proven to be safe and effective in people, VRDN-002 could become a more convenient, self-administered treatment option for TED patients."

PK/PD data • Preclinical • Ocular Inflammation • Ophthalmology • IGF1

VRDN-002, A Second-Generation Insulin Like Growth Factor-1 Receptor (IGF-1R) Inhibitory Antibody for Thyroid Eye Disease: Preclinical Pharmacokinetics and Clinical Promise (ARVO 2022) - "We sought to compare the pharmacokinetic (PK) parameters of VRDN-002 in cynomolgus monkeys to the marketed IGF-1R antibody, teprotumumab, and to estimate potential human exposures for various dosing paradigms. VRDN-002 demonstrated a desirable PK profile in non-human primates, suggesting potential as a novel therapeutic monoclonal antibody for the treatment of TED. The prolonged half-life of VRDN-002 may enable lower frequency of IV infusion and/or low-volume SC injection; each possibility awaits clinical confirmation."

PK/PD data • Preclinical • Ophthalmology

Viridian Therapeutics Secures Flexible Credit Facility for Up to $75 Million From Hercules Capital (GlobeNewswire) - "Viridian Therapeutics...today announced that the Company has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE: HTGC) for up to $75 million....'We anticipate transformational data from both VRDN-001 and VRDN-002 clinical programs in the next several quarters. We seek to progress both programs into registrational trials as fast as possible'...Under the terms of the agreement, Viridian drew an initial $5 million at closing. An additional $20 million is available at the Company’s request through June 15, 2023, with an additional $25 million available upon the Company’s achievement of certain milestones, and the remaining $25 million available subject to final lender approval...cash equivalents and short-term investments will be sufficient to fund its operations into 2024."

Financing • Ophthalmology • Thyroid Eye Disease

Viridian Therapeutics Doses First Subject in First-in-Human Clinical Trial Evaluating VRDN-002, a Next Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease (GlobeNewswire) - "Viridian Therapeutics...today announced that it has dosed the first subject in a Phase 1 clinical trial evaluating VRDN-002 for the treatment of thyroid eye disease (TED)....Topline data from the trial are expected to be announced mid-year and will inform the feasibility of a low-volume SC dosing paradigm for TED patients."

P1 data • Trial status • Ophthalmology • Thyroid Eye Disease