CLINICAL DEVELOPMENT STRATEGY

We are developing medicines to selectively eliminate senescent cells, called senolytic medicines. Our initial focus is on delivering localized therapy in osteoarthritis, ophthalmology and pulmonary disease. Beyond cellular senescence, we are uncovering additional underlying mechanisms that contribute to age-related diseases including:

  • Mitochondrial dysfunction
  • Loss of circulating youth factors
PIPELINE
PIPELINE
LEAD PRODUCT CANDIDATES

UBX0101 is being evaluated for the treatment of musculoskeletal disease with an initial focus on osteoarthritis (OA) of the knee. UBX0101 is a potent senolytic small molecule inhibitor of the MDM2/p53 protein interaction. Disruption of this protein interaction can trigger the elimination of senescent cells. Initial results from a Phase 1 clinical trial in patients with moderate to severe OA of the knee were announced in June 2019. The study demonstrated that UBX0101 was well-tolerated. Improvement in several clinical measures, including pain and function, as well as modulation of certain senescence-associated secretory phenotype (SASP) factors and disease-related biomarkers was observed after a single dose of UBX0101. The Company plans to further evaluate UBX0101 in OA of the knee in a Phase 2 trial.

UBX1967 is being evaluated for the potential treatment of age-related diseases of the eye, including age-related macular degeneration, diabetic macular edema and proliferative diabetic retinopathy. UBX1967, which is a potent senolytic small molecule inhibitor of particular members of the Bcl-2 family of apoptosis regulatory proteins, targets proteins senescent cells rely on for survival. UNITY plans to submit an IND application in early 2020 for UBX1967. UNITY entered into a license agreement with Ascentage Pharma Group Corp Limited “Ascentage Pharma” in January 2019 granting UNITY exclusive development and commercialization rights and non-exclusive manufacturing rights outside of Greater China for UBX1967 in all non-oncology indications. Inside Greater China, UNITY is obligated to commercialize UBX1967 through a joint venture with Ascentage Pharma.

CLINICAL TRIALS
A Safety and Tolerability Study of UBX0101 in Patients with Osteoarthritis of the Knee

Summary: This double-blind, randomized, placebo-controlled Phase 1 study is evaluating the safety, tolerability and pharmacokinetics of a single intra-articular injection of UBX0101 into the femoro-tibial joint of patients diagnosed with moderate to severe painful osteoarthritis of the knee.

Status: Completed

For patients or physicians interested in learning about eligibility criteria for the trial, please visit clinicaltrials.gov.