Valo Health Finishes Recruitment for Diabetic Retinopathy Trial

Valo Health, a company specializing in leveraging data and AI to advance therapeutics, has announced that they have completed enrollment for their Phase 2 Spectra clinical trial. This trial is designed to assess the efficacy of OPL-0401, an oral treatment for diabetic retinopathy, a condition affecting an estimated 11 million people in the United States. Diabetic retinopathy, particularly in its earlier stages, is a disease with limited treatment options, often requiring intravitreal injections or laser therapy for more severe cases.

The Spectra study is a significant step towards addressing the unmet needs of this patient population. It is a multi-center, randomized, double-blind, and placebo-controlled trial that will evaluate the benefits of OPL-0401, an experimental small molecule Rho kinase (ROCK) 1/2 inhibitor. This compound represents a potential breakthrough as the first oral treatment for diabetic retinopathy, offering a more convenient and potentially more effective alternative to current therapies.

Valo's Chief Medical Officer, Dr. Victor Shi, expressed gratitude to the healthcare providers and investigators involved in the trial, highlighting the importance of new therapies for patients. The company's Interim Chief Executive Officer, Graeme Bell, emphasized the prevalence of diabetic retinopathy and the significance of the study in potentially improving treatment options for this debilitating disease.

Valo's Opal Computational Platform™ has been instrumental in the drug discovery process, identifying biomarkers that could predict disease progression and contributing to the development of the company's computational capabilities. The platform is an end-to-end solution designed to integrate human-centric data across the drug development process, with the aim of accelerating the discovery of life-changing drugs and reducing associated costs and failure rates.

Dr. Charles C. Wykoff, the Director of Research at Retina Consultants of Texas and the lead investigator for the Spectra trial, noted the necessity for safe and effective oral therapeutics to manage the progression of diabetic retinopathy. The Spectra study is expected to provide valuable insights that could benefit future patients and enhance clinical trial design.

OPL-0401 has shown promise in Phase 1 and 2 studies, with over 200 healthy volunteers, including the elderly and those with renal insufficiency, demonstrating its safety and tolerability. Although it is still an investigational agent and has not yet received FDA approval, the results from the Spectra trial could pave the way for a new era in the treatment of diabetic retinopathy.

Valo Health, founded by Flagship Pioneering, is headquartered in Boston, with additional offices in Lexington and New York. The company is dedicated to advancing a robust pipeline of programs in various therapeutic areas, including cardiovascular, metabolic, renal, oncology, and neurodegenerative diseases.