Senolytics company announces full 36-week data from ASPIRE trial and considers partnerships, mergers, or even winding down.
Longevity focused biotech company UNITY Biotechnology has released complete 36-week data from its Phase 2b ASPIRE clinical study, along with a corporate update reflecting a significant shift in its direction. The company revealed it is restructuring its operations to conserve capital and pursue strategic alternatives for its pipeline programs, with a focus on reducing operational expenses and seeking external partners or transactions to advance its programs.
As part of the shift, it appears UNITY will lay off its entire workforce, retaining some consulting agreements to manage the closeout of the ASPIRE study and provide continuity during the transition. Key executives, including its CEO, CFO and Chief Legal Officer, will transition to advisory roles to support the strategic review process.
Today’s complete results from the trial reveal that the company’s lead senolytic therapy, UBX1325, achieved vision improvements comparable to the current standard of care (aflibercept) in patients with advanced diabetic macular edema (DME) who had experienced suboptimal benefit from prior anti-VEGF therapies.
At week 36, UBX1325 was statistically non-inferior to aflibercept in improving Best-Corrected Visual Acuity (BCVA), which it also achieved across most time points in the study. However, as previously reported, the trial did not meet its primary endpoint – non-inferiority in BCVA at the average of weeks 20 and 24.
In a recent interview with UNITY CEO Anirvan Ghosh, he told us that “even at week 24, we met non-inferiority, so it’s a very, very narrow technical definition. Having run a lot of trials, when a study doesn’t work, it’s rarely just one small measure falling short while everything else looks good. But that’s exactly what happened in our case.”
Of particular interest was the drug’s relative superiority in a subgroup of patients comprising 60% of the study population and representing a moderately aggressive disease phenotype.
“We believe that further development of UBX1325 would benefit from the capabilities of a company with an existing ophthalmic franchise, and we are exploring partnerships so that this program can continue to be advanced as a potential new treatment,” said Ghosh.
Despite what sounds like encouraging clinical data, UNITY is clearly not in a position to continue operating as usual. The scope of potential strategic alternatives being considered is broad and includes possible asset sales, licensing deals, collaborations, mergers or even a complete wind-down or dissolution of the company.
While today’s news is no doubt disappointing for longevity watchers, the progress made by UNITY in senotherapeutic development is still significant for the field. As Ghosh recently told us, the company’s trials have provided “very strong evidence that the fundamental senotherapeutic hypothesis has merit. We’ve shown that targeting senescent cells can lead to improved outcomes.”
“My hope for the field would be that we learn from this – to better pick the right indications, design the right studies, and continue the path forward.”
In addition to UBX1325, the company’s broader portfolio includes UBB2048, a Tie2/anti-VEGF bispecific molecule showing promising dual action in Tie2 pathway activation and VEGF inhibition with efficacy in preclinical models of retinal disease. UBX2050 is a Tie2 agonistic antibody with potential applications in conditions characterized by vascular permeability, such as chronic kidney disease and vascular dementia.
UNITY also holds a global licensing agreement with Jocasta Neuroscience for development and commercialization of alpha-Klotho-based therapeutics in neurological disorders, and it maintains a foundational intellectual property portfolio related to cellular senescence and aging across multiple disease domains.
