Unit Biotechnology announces positive data from Phase 1 trial of UBX1325
Unity Biotechnology Inc. announced 12-week data from its ongoing Phase 1 safety study of UBX1325 in patients with advanced diabetic macular edema (DME) and age-related macular degeneration (AMD) ) for which anti-VEGF treatment was no longer considered to be beneficial.
According to the company, the data shows strong and sustained responses after a single injection of UBX1325 for 12 weeks and adds substantially to the previously reported 8-week data set, which provided initial evidence of efficacy. The 24-week data from the study is expected before the end of the year.
The company noted that UBX1325, a small molecule inhibitor of Bcl-xL and the first senolytic drug candidate for ophthalmologic diseases targeting a biologic pathway distinct from anti-VEGF therapies, continues to be well tolerated without adverse effects or doses. -dependent related to treatment. limiting toxicities for up to 12 weeks.
Additionally, UBX1325 showed sustained responses in key clinical measures of disease progression in most patients for 12 weeks, including substantial improvements in best corrected visual acuity (BCVA) and thickness. of the central subfield (CST).
“It is promising to see sustained vision improvements for three months after a single dose in these patients with advanced vascular eye disease, especially since these patients had spent at least six months without standard anti-VEGF therapy. at this point, âRobert Bhisitkul, MD, PhD, professor of ophthalmology and director of the Retina Fellowship at the University of California, San Francisco, said in a statement. âThere are limited treatment options for patients who do not receive standard care, so a new therapeutic approach like UBX1325 could provide significant benefit as an alternative or adjunct to anti-VEGF treatments. “
Treatment of patients with a single injection of UBX1325 resulted in the following clinical changes 12 weeks after treatment:
Gain in ETDRS letters from baseline best corrected visual acuity (BCVA)
- Overall (for all doses): 8 out of 12 patients experienced a gain in ETDRS letters from baseline BCVA at 12 weeks
- In the high dose groups (5, 10 mcg): 5 out of 6 patients had a gain of ETDRS letters compared to the baseline value of BCVA at 12 weeks
Decrease in the thickness of the central subfield (CST)
- Overall (for all doses): 6 out of 10 patients experienced a decrease (improvement) in CST at 12 weeks, excluding two patients who received anti-VEGF rescue therapy following disease progression underlying
- In the high dose groups (5, 10 mcg): 3 out of 5 patients experienced a decrease in CST at 12 weeks, with the exception of one patient who received rescue anti-VEGF therapy following the progression underlying disease
The phase 1, open-label, single-dose escalating study includes 12 patients with advanced DME or wet AMD who are no longer expected to benefit from anti-VEGF therapies.
According to Unity, the patients in the study could not have received anti-VEGF or corticosteroid therapy for three months before receiving a single dose of UBX1325. 12 weeks after treatment with the study drug, UBX1325 demonstrated a favorable safety profile supporting further clinical development.
Additionally, the company noted that no dose-limiting toxicity was observed, with two non-serious, non-drug-related adverse events reported within 12 weeks.
âWe are excited about the trajectory of data showing both a rapid response and sustained improvements in vision and retinal structure in most patients for up to 12 weeks after a single injection of UBX1325,â said Anirvan Ghosh, PhD, chief executive of Unity, in a statement.
Ghosh said the consistency of the response at 8 and 12 weeks suggests that the functional gains seen to date can be sustained beyond 12 weeks.
“These data further support our Phase 2a proof-of-concept study in DME patients, which is already underway, and we anticipate the 12-week safety and efficacy data from this study in the first half of 2022. “said Ghosh.
Unity plans to share 8-week data from an additional cohort of wet AMD patients, as well as complete 24-week data from the original cohort of the Phase 1, single-dose ascending study, before completion. of the year.