UBX - Unity Biotech sheds 48% after mid-stage setback for wet AMD candidate

2023-03-27 08:32:38 ET

Unity Biotechnology ( NASDAQ: UBX ) lost ~48% pre-market Monday after announcing that its lead candidate UBX1325 failed to outperform Regeneron’s ( REGN ) blockbuster eye therapy aflibercept in a Phase 2 trial for wet age-related macular degeneration (AMD).

The Part A portion of the proof-of-concept ENVISION trial involved 51 patients who received either two doses of UBX1325 at week 0 and week four or anti-VEGF agent aflibercept (Eylea) 2 mg every eight weeks. At the time of enrollment, the patients were receiving aflibercept, but without an optimum benefit.

While results indicated that most patients in the UBX1325 arm did not require anti-VEGF rescue, the experimental therapy did not achieve the non-inferiority threshold compared to aflibercept through 24 weeks.

The company attributed the underperformance to the strength on the control arm, where patients on aflibercept achieved an “early and unexpected” visual gain of 3.5 letters at week 2, which they later maintained for the study duration.

In the weeks ahead, Unity ( UBX ) expects to update on the results from the Part B long-term extension portion of the trial.

Read: Pointing to Eylea as well as Roche’s ( OTCQX:RHHBY ) Vabysmo, Seeking Alpha contributor Busted IPO Forum argues that UBX1325 should demonstrate “not only superiority in efficacy, but also at least non-inferiority in terms of duration of benefit against these two therapies.”

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