Unity Biotechnology senolytic candidate UBX0101

UNITY Biotechnology is working on the removal of senescent cells, which accumulate with age, drive chronic inflammation, and spur various age-related diseases.

Founded by Drs. Jan van Deursen, Judith Campisi, Nathaniel David, and Daohong Zhou, the company has been developing senolytic therapies that can purge senescent cells from the body without harming healthy cells. The idea is that removing these problem cells could help us to maintain health and remain free of disease as we grow older.

The company’s lead candidate drug, UBX0101, is designed to treat musculoskeletal disease, with an initial focus on osteoarthritis. The candidate is a uniquely senolytic small molecule inhibitor of the p53/MDM2 protein interaction. Disruption of this protein interaction triggers the destruction of senescent cells.

An Investigational New Drug (IND) application for UBX0101 was cleared by the U.S. FDA, and a Phase 1 clinical trial in osteoarthritis of the knee was initiated in the second quarter of 2018. Initial results from the Phase 1 study have proven positive with clinically significant improvements in patients with osteoarthritis.

Unfortunately as of August 2020, following disappointing results for the Phase 2 osteoarthritis human trial, UNITY is unlikely to continue developing UBX0101 further. The company expects to complete collection of the Phase 2 24-week data, as well as that from the ongoing Phase 1b high-dose, repeat-dose study in the second half of 2020. 

UNITY is also developing other senolytic candidates targeting other pro-survival pathways used by senescent cells for a variety of age-related diseases, including diabetic retinopathy, diabetic macular edema, glaucoma, age-related macular degeneration, idiopathic pulmonary fibrosis, systemic sclerosis, chronic obstructive pulmonary disease, kidney disease, and mitochondrial dysfunction.