Simply 5 months after Biogen’s head of early R&D Anirvan Ghosh left the corporate to take up the CEO submit at Unity Biotechnology, its key main knee ache program has failed and been thrown onto the trash heap.
The drug, referred to as UBX0101, had already traveled a rocky path: Final 12 months, Unity posted part 1 knowledge linking UBX0101 to improved scores on ache symptom questionnaires in sufferers with reasonable to extreme osteoarthritis (OA), however the drug didn’t statistically outperform placebo within the second a part of the examine.
Unity, nonetheless, plowed on, seeing sufficient promise within the knowledge to maneuver the p53/MDM2 interplay inhibitor into part 2. Unity lately accomplished enrollment within the 183-subject trial, setting it as much as submit top-line knowledge within the second half of the 12 months.
Now the info are in, however they’ve confirmed grim studying: The 12-week outcomes from the part 2 examine in sufferers with reasonable to extreme painful OA of the knee discovered that there “was no statistically important distinction” between any arm of UBX0101 and placebo.
This was primarily based from a baseline in WOMAC-A, a longtime measurement of ache in OA.
“Given these outcomes, Unity doesn’t anticipate progressing UBX0101 into pivotal research and can slim the corporate’s near-term focus to its ongoing ophthalmologic and neurologic illness packages,” it mentioned in a press release. These are earlier bets, and the setback is a serious intestine punch for the corporate.
This will even be a blow for Ghosh, on condition that it’s his first main knowledge readout since changing into chief. “Whereas these should not the outcomes we had hoped for, the proof that senescent cells contribute to illnesses of getting old stays compelling, and we’re excited to advance UBX1325 for retinal illnesses, which inhibits Bcl-xL, a definite senolytic goal,” he mentioned.
Unity works on an anti-aging philosophy primarily based on eradicating amassed senescent cells, that are a mechanism of getting old and a driver of age-associated illnesses. The speculation is that these therapies can minimize out these senescent cells to decelerate and even reverse age-associated illness and restore tissue.
These newest knowledge are a setback for the biotech’s idea. Its shares dropped 60% Monday morning on the information.