The trial enrolled subjects with moderately severe or severe non-proliferative diabetic retinopathy or mild proliferative diabetic retinopathy. Credit: SUPERMAO / Shutterstock.

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.

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The studies were sponsored by French pharmaceutical company Sanofi prior to Valo Health’s acquisition of the programme.

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OPL-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.