UNITY cuts lead program after clinical trial fail

Company to focus on ophthalmologic and neurologic programs as Phase 2 knee osteoarthritis clinical study fails to meet primary endpoint.

Senolytic therapy developer UNITY Biotechnology has announced the 12-week results from its Phase 2 study of UBX0101, a p53/MDM2 interaction inhibitor, in 183 patients with moderate-to-severe painful osteoarthritis of the knee. The study found no statistically significant difference in pain reduction between the use of UBX0101 and a placebo.

Longevity.Technology: Dang it. UNITY’s lead candidate drug, UBX0101, is a uniquely senolytic small molecule inhibitor of protein interaction. Disruption of this protein interaction triggers the destruction of senescent cells. So although this news relates to knee OA, it has relevance to the wider rejuvenation market. UNITY is also developing senolytic candidates for a variety of other age-related diseases.

UNITY said it “does not anticipate progressing UBX0101 into pivotal studies” and will focus instead on its ongoing ophthalmologic and neurologic disease programs. The company is evaluating compounds for the potential treatment of age-related diseases of the eye, including age-related macular degeneration, diabetic macular edema and proliferative diabetic retinopathy.

“While these are not the results we had hoped for, the evidence that senescent cells contribute to diseases of aging remains compelling.”

“While we are disappointed in the outcome of the 12-week results of the Phase 2 study of UBX0101, I would like to acknowledge our team’s hard work and commitment to executing a robust study that has provided clear results,” said UNITY’s chief medical officer Jamie Dananberg.

The company’s stock fell 48% on today’s announcement, although setbacks such as this are not uncommon in the longevity sector, particularly among publicly traded companies such as UNITY and resTORbio, which are more susceptible to investor reaction.

“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,” said UNITY CEO Anirvan Ghosh. “While these are not the results we had hoped for, the evidence that senescent cells contribute to diseases of aging remains compelling, and we are excited to advance UBX1325 for retinal diseases, which inhibits Bcl-xL, a distinct senolytic target.”

“Diabetic macular edema and diabetic retinopathy are attractive not only because of the strength of underlying biology, but also because of the sensitive, quantitative, and objective clinical assessments available,” added Ghosh. “The burden of senescent cells in various diseases of aging is increasingly evident, which together with our research gives us great conviction in our science and the future of our pipeline.”
Keep it up guys: only the brave etc.

Image credit: SlyzyyPexels

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