– Phase 2 study of UBX0101 in patients with osteoarthritis has completed enrollment –
– Topline 12- and 24-week results now expected in 2H 2020 –
– First patient dosed in phase 1b study to explore higher dose and repeat doses –
– First-in-human study initiation for ophthalmology program expected in 2H 2020 –
SAN FRANCISCO, Feb. 25, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) (NASDAQ:UBX), a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today provided pipeline and business updates.
Recent Highlights and Business Updates
Osteoarthritis – UBX0101
In October 2019 UNITY announced that the first patient had been dosed in a Phase 2 study of UBX0101, an inhibitor of the MDM2/p53 protein-protein interaction, in patients with moderate-to-severe osteoarthritis (OA) of the knee. The study is now fully enrolled with 183 patients. The study is randomized, double-blind, and placebo-controlled and will evaluate three doses (0.5 mg, 2.0 mg and 4.0 mg) of UBX0101 administered via a single intra-articular injection. Both 12- and 24-week results are now expected in the second half of 2020.
"We are pleased to announce the completion of enrollment ahead of schedule in our Phase 2 study of UBX0101 in patients with moderate-to-severe osteoarthritis of the knee," said Keith Leonard, chairman and chief executive officer of UNITY. "We believe the rapid enrollment of this study can, in part, be explained by the significant unmet need of patients suffering from this debilitating condition. We now anticipate that both the 12-week and 24-week data will be available in the second half of this year."
UNITY has also dosed the first patients in a Phase 1b study to explore the safety, tolerability and initial efficacy of a higher dose (8.0 mg) and repeated doses (4.0 mg x 2, separated by 1 month) of UBX0101. The study is expected to enroll approximately 36 patients with 12-week results expected in the second half of 2020.
Ophthalmology
UNITY's lead ophthalmology candidates, UBX1325 and UBX1967, are currently in the final phases of Investigational New Drug (IND) enabling non-clinical toxicology studies. Both senolytic molecules are inhibitors of particular members of the Bcl-2 family of apoptosis regulatory proteins which have shown distinct pharmacokinetic profiles in preclinical studies. UNITY intends to complete IND-enabling studies for both molecules prior to selecting the first molecule to advance to a first-in-human study to explore safety and tolerability of this novel mechanism of action for age-related eye diseases. UNITY expects to initiate a Phase 1 safety study for this program in the second half of 2020. The overall clinical program is directed at multiple age-related diseases of the eye, such as age-related macular degeneration, diabetic retinopathy and diabetic macular edema.
Cash Update
As of December 31, 2019 cash, cash equivalents and investments were $125.0 million (unaudited). UNITY expects this is sufficient to fund operations into the second half of 2021.
UNITY expects to release its audited financial results for 2019 on March 11, 2020.
About UBX0101
UBX0101 is being evaluated for the treatment of musculoskeletal disease, with an initial focus on osteoarthritis (OA) of the knee. UBX0101 is a small molecule inhibitor of the MDM2/p53 protein-protein interaction. UBX0101 binds to MDM2, raising p53 levels which in turn, we believe, causes 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. Dose-dependent improvement in several clinical measures, including pain and function, as well as modulation of multiple senescence-associated secretory phenotype (SASP) factors and disease-related biomarkers, was observed after a single dose of UBX0101.
Investors
Endurance Advisors
Peter Rahmer
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Media
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Jason Spark
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