UNITY Biotechnology has reported positive results from the Phase I safety clinical trial of UBX1325 for the treatment of advanced vascular eye disease.
Trial participants had advanced disease from diabetic macular edema (DME) or wet age-related macular degeneration (wet AMD) and no longer benefitted from anti-vascular endothelial growth factor (VEGF) therapy.
An investigational small molecule drug, UBX1325 inhibits Bcl-xL. It is developed to block the function of proteins required for the survival of senescent cells.
UBX1325 is said to be the first senolytic therapy assessed in an ophthalmological clinical trial.
According to the Phase I data, the drug was well-tolerated without any treatment-related adverse events or dose-limiting toxicities. Two nonserious, nondrug-related adverse events were noted during the trial.
Most DME and wet AMD subjects who received a single injection of UBX1325 experienced quick improvements in best-corrected visual acuity (BCVA), central subfield thickness (CST), and sub- and intra-retinal fluid (SRF, IRF).
BCVA, CST, SRF and IRF are considered important clinical measures of disease progression.
The open-label, single-ascending dose Phase I trial enrolled a total of 12 patients, of which ten had a gain in ETDRS letters from baseline in BCVA at two weeks across all doses tested.
Meanwhile, six of 12 subjects achieved an improvement in CST at two weeks. Three of four wet AMD patients showed a reduction in SRF / IRF along with improvement in disease-related pathology.
UNITY Biotechnology chief medical officer Jamie Dananberg said: “The patients enrolled in this study had advanced disease for whom anti-VEGF therapies, the standard of care for DME and wet AMD, were no longer thought to be of benefit.
“Seeing treatment-related improvement in these difficult-to-treat patients is very promising and supports the investigation of UBX1325’s potential as a differentiated, disease-modifying treatment option for a broad patient population.”
Dosing has begun in a Phase IIa trial to evaluate the safety and efficacy of UBX1325 in a wider DME patient population, with results anticipated in the first half of next year.
The company is also recruiting more advanced wet AMD patients in the Phase I trial to obtain further data to support a Phase IIa trial in this disease area.