Unity Biotechnology has reported that its Phase II clinical trial of UBX0101 in patients with moderate to severe painful osteoarthritis (OA) of the knee failed to meet the primary endpoint at 12 weeks.
According to the 12-week data, no statistically significant difference was found between UBX0101 and placebo groups for a change from baseline in WOMAC-A, which measures pain in OA.
Based on these results, the company does not expect UBX0101 to advance into pivotal studies and will limit its near-term focus to ongoing ophthalmologic and neurologic disease programmes.
UBX0101 is a p53/MDM2 interaction inhibitor. The double-blind, placebo-controlled Phase II study assessed a single intra-articular injection of a 0.5mg, 2mg or 4mg dose of the drug candidate versus placebo in a total of 183 patients.
The drug candidate was reported to be well-tolerated at all dose levels. Adverse events (AEs) were consistent with previous data, without any treatment-related serious AE.
Unity Biotechnology CEO Anirvan Ghosh said: “Developing novel treatments that selectively eliminate or modulate senescent cells is at the heart of what we do, and we have generated valuable data that will enable us to learn from this study and inform future studies in diseases of aging.
“While these are not the results we had hoped for, the evidence that senescent cells contribute to diseases of ageing remains compelling, and we are excited to advance UBX1325 for retinal diseases, which inhibits Bcl-xL, a distinct senolytic target.”
The company intends to obtain the Phase II 24-week results, along with data from the ongoing Phase Ib high-dose, repeat-dose study in the second half of this year.
Last year, Unity performed the Phase I trial of UBX0101 in patients with moderate to severe osteoarthritis (OA) of the knee.