Valo Health Completes Enrollment of OPL-0401 Phase 2 Study for the Treatment of Diabetic Retinopathy

2024-03-04

临床2期并购

BOSTON, March 4, 2024 /PRNewswire/ -- Valo Health, Inc (Valo), a technology company focused on utilizing large scale data and artificial intelligence (AI) driven computation to discover and develop therapeutics, today announced full enrollment in the company's Phase 2 Spectra clinical trial. Spectra is a multi-center randomized, double-blind, placebo-controlled study to evaluate the potential benefit of oral OPL-0401 in patients with moderately severe or severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR). OPL-0401 is an investigational small molecule Rho kinase (ROCK) 1/2 inhibitor and a potential first-in-class oral option for patients with diabetic retinopathy (DR), where the current treatment options are limited to patients with more severe or advanced vision-threatening levels and consist mainly of intravitreal injections and laser treatment. The company anticipates a topline readout before the end of 2024. Valo would like to thank the patients and trial investigators for their participation and contributions to the study. "We are encouraged by the full enrollment of our Phase 2 trial ahead of our projected timeline, a strong testament to the potential that new therapies could bring for patients felt by the healthcare providers participating in this trial," said Valo's Chief Medical Officer, Victor Shi, MD. "We are so grateful to the Spectra trial investigators, recognizing the opportunity and confidence in identifying a more effective or convenient therapy over current therapeutic options, for their support through trial enrollment completion." "Diabetic retinopathy has an estimated prevalence of approximately 11 million people in the United States and remains an underserved illness, especially in earlier stages of the disease," said Graeme Bell, Interim Chief Executive Officer of Valo Health. "The study of OPL-0401 for oral delivery represents the potential for significant improvement in the treatment of this progressive and debilitating disease. In addition, we leveraged Valo's Opal Computational Platform™, our end-to-end drug discovery and development platform, to identify biomarkers that may predict which patients are likely to progress to the next stage of DR, and are hopeful to gain further insights from Spectra that could potentially benefit future patients and clinical trial design and execution." Valo used its Opal Platform and unique access to real-world evidence to evaluate the diabetic retinopathy patient population and OPL-0401 and its potential. The company's internal pipeline of product candidates and discovery programs utilize Opal, and the learnings from these programs are integrated and utilized to further develop its computational capabilities. "There remains a tremendous unmet need for safe and effective oral therapeutics that can slow the progression of NPDR and PDR and improve diabetic retinopathy severity levels," said Charles C. Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas in Houston and Spectra Lead Investigator. "Today, physicians often delay treating patients with NPDR with current FDA-approved therapeutics because of the need for repeated intravitreal injections. Spectra is a well-designed, proof of concept study that I hope will yield positive results for patients with NPDR." 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 (sponsored by Sanofi prior to our acquisition of the program) 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-0401 is an investigational agent and has not been approved by the U.S. Food and Drug Administration (FDA), and its safety and efficacy have not been established. About Valo Health Valo Health, Inc is a technology company focused on utilizing large scale data and AI-driven computation to discover and develop therapeutics. 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 end-to-end drug discovery and development platform with a unified architecture designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs, initially focused on cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, and New York, NY. To learn more, visit valohealth.com. Contacts Investors: Graeme Bell, gbell@valohealth.com Media: Kate Clayton, kclayton@valohealth.com