Valo Health has announced it will no longer independently develop its drug candidate for diabetic retinopathy, OPL-0401, after a phase 2 trial outcome. The decision comes as the drug did not meet the primary or secondary endpoints in the SPECTRA trial. Despite this, Valo Health noted that OPL-0401 was well-tolerated and showed potential in preventing disease progression in diabetic retinopathy, a leading cause of blindness.
OPL-0401, a Rho kinase (ROCK1/2) inhibitor, was Valo Health's lead and only clinical-stage drug candidate. The company emphasized that this setback does not reflect on its Opal computational drug discovery platform, which utilizes real-world patient data to identify and develop new therapies. Opal is distinguished by its ability to predict pharmacokinetics, ADME (absorption, distribution, metabolism, and excretion), toxicity, and the functional effects of compounds, setting it apart from other AI-based drug discovery systems.
Valo Health has entered into an R&D alliance with Novo Nordisk, which has invested $60 million upfront in programs targeting cardiometabolic diseases, in a deal potentially worth up to $2.7 billion. Moving forward, Valo Health plans to leverage Opal to discover new therapeutic targets, validate these targets in human-centric models, and develop new medicines through its AI-enabled closed-loop small molecule design.
Brian Alexander, CEO of Valo Health and CEO-Partner of Flagship Pioneering, expressed optimism about the potential role of OPL-0401 in treating diabetic retinopathy. He highlighted the significant unmet medical need for patients suffering from this condition, which is a leading cause of blindness in the US. Current treatment options are limited to invasive intravitreal injections and laser treatment, primarily for patients with more severe or advanced disease.
Alexander also pointed out that the data from the SPECTRA trial in non-proliferative diabetic retinopathy suggest clinical activity at certain doses, supporting further clinical evaluation of OPL-0401 in this indication. Valo Health is now seeking a partner to continue the development of OPL-0401, aiming to address the critical need for effective treatments for diabetic retinopathy.
