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UBX

Unity Biotechnology

$9.19

0.5 (5.75%)

07:06
06/18/19
06/18
07:06
06/18/19
07:06

Unity Biotechnology says UBX0101 was safe, well-tolerated in Phase 1 study

UNITY Biotechnology announced results from its first-in-human Phase 1 study of UBX0101 in patients with moderate to severe osteoarthritis of the knee. The study demonstrated that UBX0101 was safe and well-tolerated. Improvement in several clinical measures, including pain, function, as well as modulation of certain senescence-associated secretory phenotype factors and disease-related biomarkers was observed after a single dose of UBX0101. The Phase 1 clinical trial of UBX0101 is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and pharmacokinetics of a single intra-articular injection of UBX0101 in patients diagnosed with moderate to severe painful OA of the knee. UBX0101 is a p53/MDM2 interaction inhibitor that targets selective elimination of senescent cells. In Part A, 48 patients were randomly assigned to receive one of six dose levels of UBX0101 or placebo in a 3:1 randomization. Primary endpoints were safety and tolerability. Secondary and exploratory endpoints included plasma pharmacokinetics, synovitis as measured by MRI, pain, and measurement of SASP factors and disease-related biomarkers present in synovial fluid and plasma. In Part B, 30 patients were randomized to receive UBX0101 or placebo in a 2:1 randomization. Primary endpoints were safety and tolerability. Secondary and exploratory endpoints included changes in the levels of SASP factors and disease-related biomarkers present in synovial fluid and plasma, and pain. Synovial fluid samples were obtained at baseline and four weeks post-treatment. In Part A, UBX0101 was well tolerated up to the maximum administered dose of 4 mg. There were no serious adverse events and no patients discontinued because of an adverse event. There were no dose-dependent adverse events or relevant clinical laboratory findings. The majority of adverse events were mild. In Part B, UBX0101 was well tolerated at the 4 mg dose. There were no serious adverse events and no patients discontinued because of an adverse event. The majority of adverse events were mild and there were no relevant clinical laboratory findings. UBX0101 demonstrated dose-proportional plasma pharmacokinetics. Model-based predicitons of concentrations within the knee suggested that doses at or above 1 mg may be pharmacologically active. This informed the prospectively defined low dose and high dose groupings for analyses. In Part A, evaluation of pain by NRS measured at 12 weeks demonstrated a dose-dependent and clinically meaningful reduction. The range of mean baseline values was between 5.90 to 6.76. In Part A, evaluation of pain by WOMAC-A mean item score measured at 12 weeks demonstrated a dose-dependent and clinically meaningful reduction. The range of mean baseline values was between 1.80 to 2.36. In Part B, WOMAC-A, measured at 4 weeks, showed a numerical reduction that was not significantly different from placebo. In Part A, evaluation of function by WOMAC-C mean item score demonstrated a dose-dependent and clinically meaningful improvement. The range of mean baseline values was between 1.40 to 2.47. There were no observed changes in stiffness as measured by WOMAC-B. Evaluation of Patient Global Impression of Change with treatment demonstrated a higher proportion of patients being "much improved" or "very much improved" versus placebo. Evaluation of synovial inflammation by MRI detected no significant placebo adjusted change at any dose level. In Part A, an insufficient number of matched samples were collected due to a lack of adequate levels of synovial fluid in patients for sampling. Therefore, an analysis of change in biomarkers from baseline to 12 weeks was not performed. In Part B, 19 biomarkers were analyzed across 20 matched pair samples. In approximately half the biomarkers measured in synovial fluid modulation was observed consistent with elimination of senescent cells and potential improvement in the tissue environment. Changes were observed in MMPs, tissue remodeling factors, and inflammatory cytokines. These biomarkers were: MMP-3, MMP-10, MMP-12, MMP-13, IL-6, IL-10, CCL20, A2M, ICAM-1 and VEGF-C.

  • 20

    Jun

UBX Unity Biotechnology
$9.19

0.5 (5.75%)

05/07/19
SBSH
05/07/19
NO CHANGE
SBSH
Buy
Citi opens positive 90-day catalyst watch on Unity Biotechnology
Citi analyst Yigal Nochomovitz opened a 90-day catalyst watch on Unity Biotechnology ahead of the Phase 1 data in Q2 for UBX0101 in osteoarthritis of the knee. Expectations for the data "remain muted" with the stock down 50% since the initial public offering one year ago, Nochomovitz tells investors in a research note. He sees a low bar to achieving proof-of-biology given that this is the first-ever study testing the senescent cell hypothesis in clinical trials. Nochomovitz expects the stock to be up at least 50% if at least some of the clinical endpoints hit statistical significance. The analyst keeps a Buy rating on Unity Biotechnology.
03/07/19
CANT
03/07/19
INITIATION
Target $21
CANT
Overweight
Cantor sees multiple potential blockbusters for Unity Biotechnology
Cantor Fitzgerald analyst Elemer Piros last night initiated coverage of Unity Biotechnology with an Overweight rating and $21 price target. The company is making progress on treatments that could extend healthspan, a longer disease-free state, by targeting indications that are associated with aging, Piros told investors in a research note. He believes Unity has a portfolio with multiple potential blockbusters. With greater than 46M Americans over the age of 65, expected to increase to 98M by 2060, a large market exists for treating diseases of aging, said the analyst.
03/06/19
CANT
03/06/19
INITIATION
Target $21
CANT
Overweight
Unity Biotechnology initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Elemer Piros initiated Unity Biotechnology with an Overweight and $21 price target.
09/06/18
MZHO
09/06/18
INITIATION
Target $33
MZHO
Buy
Unity Biotechnology initiated with a Buy at Mizuho
Mizuho initiated Unity Biotechnology with a Buy and $33 price target.

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