UNITY Biotechnology, Inc. Announces First Patient Dosed in Phase 2 Study of UBX0101 in Osteoarthritis of the Knee
“In June, we announced promising results from our Phase 1 study of UBX0101 in patients with OA of the knee showing that our senolytic molecule was well tolerated and had a dose-dependent improvement in pain and function across multiple clinical endpoints,” said
The Phase 2 study of UBX0101 in patients with painful, moderate-to-severe OA of the knee is expected to enroll approximately 180 patients. Initial 12-week results are expected in the second half of 2020. The study is a randomized, double-blind, placebo-controlled study evaluating three UBX0101 doses (0.5mg, 2.0mg and 4.0mg) administered via a single intra-articular injection. The primary measure will be an assessment of knee pain at 12 weeks using the WOMAC®-A instrument. Secondary measures will include safety and tolerability, pain (by a 0-10 Numerical Rating Scale, or NRS) and function (by WOMAC®-C) at 12 weeks, as well as all of these endpoints at 24 weeks.
UBX0101 is being evaluated for the treatment of musculoskeletal disease, with an initial focus on OA of the knee. UBX0101 is a senolytic small molecule inhibitor of the MDM2/53 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
OA is a degenerative disease that negatively impacts cartilage, subchondral bone and the synovial tissue lining the joint, causing pain and physical impairment. OA is a highly prevalent disease, symptomatically affecting as many as 10% to 15% of the world’s population over age 60, and results in a decline in quality of life. The most common joint affected by OA is the knee. Importantly, the current standard of care addresses only the symptoms of OA, which temporarily reduces joint inflammation and pain, but does not address the root cause of disease. UNITY believes that the accumulation of senescent cells is a significant contributing factor in OA and that the selective elimination of these cells may be therapeutic.
UNITY is developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. UNITY's initial focus is on creating senolytic medicines to selectively eliminate senescent cells and thereby treat age-related diseases, such as osteoarthritis, eye diseases and pulmonary diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.
This press release contains forward-looking statements, including: statements related to UNITY’s understanding of cellular senescence and the role cellular senescence plays in diseases of aging,; UBX101’s potential to selectively eliminate senescent cells in patients with OA of the knee; the potential benefits, activity, effectiveness and safety of UBX0101; the design of UNITY’s Phase 2 study and expected timing of the expected timing of the availability and announcement of initial results from the Phase 2 study. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the uncertainties inherent in the drug development process, including UNITYs early stage development and its understanding of cellular senescence biology; the expectation that UNITY will need additional funds to finance its operations; UNITY’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that UNITY’s clinical trials will not be successful; UNITY’s dependence on the success of UBX0101; UNITY’s reliance on third parties for the manufacture of UNITY’s product candidates; possible regulatory developments in
Endurance Advisors Peter Rahmerprahmer@enduranceadvisors.com Media Canale Communications Jason Sparkjason@canalecomm.com
Source: Unity Biotechnology, Inc.