US-based health technology company Valo Health has finished enrolling subjects in its Phase II Spectra clinical trial of OPL-0401, an investigational oral treatment for diabetic retinopathy (DR).
The randomised, placebo-controlled trial is designed to assess the potential benefits of the therapy in subjects with moderately severe or severe non-proliferative DR (NPDR) or mild proliferative DR (PDR).
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The company expects to report top-line data from the Spectra trial before the end of this year.
A small molecule Rho kinase (ROCK) 1 and 2 inhibitor, OPL-0401 has demonstrated safety and tolerability in Phase I and II studies involving more than 200 healthy volunteers.
These subjects included elderly individuals and those with renal insufficiency.
The studies were sponsored by French pharmaceutical company Sanofi prior to Valo Health’s acquisition of the programme.
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By GlobalDataOPL-0401 has also shown evidence of pharmacological activity in a non-ophthalmologic human vascular disease proof-of-principle study.
The drug is still an investigational agent and has not been approved by the US Food and Drug Administration (FDA), with its safety and efficacy yet to be established.
Valo Health used its Opal Platform and real-world evidence to assess the DR patient population and the potential of OPL-0401.
Valo Health chief medical officer Victor Shi said: “We are encouraged by the full enrolment of our Phase II 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.
“We are so grateful to the Spectra trial investigators, recognising the opportunity and confidence in identifying a more effective or convenient therapy over current therapeutic options, for their support through trial enrolment completion.”
In September last year, Valo Health signed an agreement with Novo Nordisk for the discovery and development of new therapies for cardiometabolic diseases based on Valo’s large human dataset and AI-powered computation.
