Valo Health Announces First Patient Dosed In The OPL-0401 Phase 2 Study Of An Oral ROCK1/2 Inhibitor For The Treatment Of Non-Proliferative Diabetic Retinopathy

Valo's Opal Computational Platform™ being used to select a patient subset within non-proliferative diabetic retinopathy patients at high risk of progressing toward vision-threatening disease

Boston, MA /PRNewswire/ - Valo Health, Inc. ("Valo"), the technology company focused on transforming the drug discovery and development process using human-centric data and artificial intelligence, today announced that dosing has commenced in its Phase 2 study - a multi-center randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of oral OPL-0401 in patients with mild, moderate, and severe non-proliferative diabetic retinopathy (NPDR). OPL-0401 is an investigational small molecule Rho kinase (ROCK) 1/2 inhibitor and a potential first-in-class oral option for patients with NPDR, where the current treatment options are intravitreal injections, surgery, or laser treatment.

The Spectra study was designed using Valo's Opal Computational Platform which enabled real-world data analyses intended to identify patient populations that could potentially benefit most from early treatment. Further, the study is designed to enable data capture that can support not only the expansion of Valo's data lake but also subsequent analyses for further patient characterization, response prediction, and beyond.

"Over 100 million patients have diabetic retinopathy worldwide, and there is a significant need to stop the progression of the disease, especially in the early phases of this potentially devastating illness" said Dave Morris, MD, President Technology and Therapeutics at Valo Health. "Valo intends to use Opal throughout OPL-0401's development to improve precision and better target our drugs to appropriate patients. This can take the form of using real-world data to inform patient selection or utilizing data from our clinical trials to develop predictive and prognostic biomarkers to guide drug development and therapeutic decision making."

"We are thrilled to be using Valo's Opal Platform across the entire spectrum of development: discovery, translation, and human clinical trials," said David Berry, Valo's founder & Chief Executive Officer. "It is our belief that the way to develop drugs faster and better is to match the mechanism of the drug to the sub-population of patients most likely to benefit. Valo's Opal Platform gives us the tools to use data and AI/ML technology in order to accomplish this. Importantly, the data generated will continue to be used in an iterative fashion beyond our individual programs. This continuous learning process improves and accelerates decision making with the goal of identifying novel opportunities to benefit patients with OPL-0401 and other Valo assets."

"Patients are in need of new therapeutics with appropriate benefit-risk profiles that can enable treatment of diabetic retinopathy earlier in the course of disease," said Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas in Houston and Spectra Lead Investigator. "The computational enablement afforded by Valo's Opal Platform provides an exciting opportunity to identify these patients who will benefit from an oral treatment option such as OPL-0401."

Additional information about Spectra (NCT05393284) can be found at www.clinicaltrials.gov

About OPL-0401
OPL-0401 is a ROCK (Rho-Kinase) 1/2 inhibitor with unique physiochemical properties that make it suitable as an oral treatment option for patients with vascular diseases of the eye such as DR. OPL-0401 has been found to be generally safe and well tolerated in Phase 1 and 2 studies of > 200 healthy volunteers including elderly, and individuals with renal insufficiency. OPL-0401 has demonstrated evidence of pharmacologic activity in a non-ophthalmologic human vascular disease proof-of-principle study. OPL-401 is an investigational agent and has not been approved by the Food and Drug Administration, and its safety and efficacy have not been established.

About Valo Health
Valo Health, Inc. ("Valo") is a technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence driven computation. As a digitally native company, Valo aims to fully integrate human-centric data across the entire drug development life cycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing costs, time, and failure rates. The company's Opal Computational Platform^™ is an integrated set of capabilities designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs across cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, New York, NY, Branford, CT, and San Francisco, CA. To learn more, visit www.valohealth.com