It is an ugly market for biotech companies seeking funding, and this has been the case for going on two years now. In this environment companies can only survive for so long. Smaller biotech companies have been fading into oblivion left and right in this past year as investors remained very risk averse. UNITY Biotechnology, developing senolytic therapies to clear senescent cells from aged tissues, is now one of the higher profile companies to run out of funding. While demonstrating some success in recent clinical trials, clearly the company hasn't achieved a glowing enough success to convince investors to continue to back further progress towards the clinic.
UNITY has pioneered the local rather than systemic use of senolytic drugs, and on the whole their results suggest that this is not a viable approach in most circumstances; it doesn't play to the strengths of senolytic drugs. Senescent cells cause issues via their inflammatory secretions, and while a nearby cell will in principle produce a larger effect with its secretions than a distant cell will, the body is large in comparison to any single organ, and there are many times more distant senescent cells than local senescent cells.
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. "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."
View the full article at FightAging
