- UBX0101 failed to meet 12-week primary endpoint
- Guidance for UNITY’s Bcl-xL inhibitor UBX1325 in retinal disease remains unchanged
- UNITY to focus senescence programs on ophthalmologic and neurologic diseases in near-term
SOUTH SAN FRANCISCO, CA, USA I August 17, 2020 I UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today announced the 12-week results from the Phase 2 study of UBX0101, a p53/MDM2 interaction inhibitor, in patients with moderate-to-severe painful osteoarthritis (OA) of the knee. There was no statistically significant difference between any arm of UBX0101 and placebo at the 12-week endpoint for change from baseline in WOMAC-A, an established measurement of pain in OA. Given these results, UNITY does not anticipate progressing UBX0101 into pivotal studies and will narrow the company’s near-term focus to its ongoing ophthalmologic and neurologic disease programs.
“Osteoarthritis of the knee is a debilitating disease for many individuals,” said Jamie Dananberg, M.D., chief medical officer of UNITY. “While we are disappointed in the outcome of the 12-week results of the Phase 2 study of UBX0101, I would like to acknowledge our team’s hard work and commitment to executing a robust study that has provided clear results.”
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. The full results from the Phase 2 and Phase 1b studies will be presented at a future medical meeting.
Phase 2 12-week Data
In the Phase 2 double-blind, placebo-controlled study, 183 patients with moderate to severe painful OA of the knee were randomized to receive placebo, 0.5 mg, 2.0 mg or 4.0 mg of UBX0101 via a single intra-articular injection. The analysis results for the primary endpoint are shown in the table below.
| |
Primary Endpoint: Least Square Means Change from Baseline in WOMAC-A (0-4 scale) at Week 12 |
| Treatment |
WK 12 CFBL |
Pbo-Adjusted CFBL Wk 12 |
P-Value* |
| Placebo (N = 46) |
-1.017 |
N/A |
N/A |
| UBX0101 0.5 mg (N = 45) |
-0.924 |
0.093 |
0.5222 |
| UBX0101 2.0 mg (N = 46) |
-1.052 |
-0.035 |
0.8069 |
| UBX0101 4.0 mg (N = 46) |
-1.019 |
-0.002 |
0.9870 |
| |
|
|
|
|
* P-Value is obtained from MMRM testing CFBL against Placebo
UBX0101 was well-tolerated at all dose levels and adverse events (AEs) were consistent with previously reported data. There were no treatment-related serious AEs and only one patient discontinued because of an AE (for an unrelated cardiovascular event). The most common treatment emergent AE was procedural pain in the study knee (n = 10/183 (5.5%)).
“Developing novel treatments that selectively eliminate or modulate senescent cells is at the heart of what we do, and we have generated valuable data that will enable us to learn from this study and inform future studies in diseases of aging,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “While these are not the results we had hoped for, the evidence that senescent cells contribute to diseases of aging remains compelling, and we are excited to advance UBX1325 for retinal diseases, which inhibits Bcl-xL, a distinct senolytic target. Diabetic macular edema and diabetic retinopathy are attractive not only because of the strength of underlying biology, but also because of the sensitive, quantitative, and objective clinical assessments available. The burden of senescent cells in various diseases of aging is increasingly evident, which together with our research gives us great conviction in our science and the future of our pipeline.”
Additional information about the study can be found on www.clinicaltrials.gov (NCT04129944).
Financial Outlook
Based on current operating plans, UNITY believes that current cash, cash equivalents and investments are sufficient to fund operations well into 2022.
About UNITY
UNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. UNITY’s initial focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related diseases, such as osteoarthritis, eye diseases, neurological diseases and pulmonary diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.
SOURCE: Unity Biotechnology
Post Views: 33
- UBX0101 failed to meet 12-week primary endpoint
- Guidance for UNITY’s Bcl-xL inhibitor UBX1325 in retinal disease remains unchanged
- UNITY to focus senescence programs on ophthalmologic and neurologic diseases in near-term
SOUTH SAN FRANCISCO, CA, USA I August 17, 2020 I UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today announced the 12-week results from the Phase 2 study of UBX0101, a p53/MDM2 interaction inhibitor, in patients with moderate-to-severe painful osteoarthritis (OA) of the knee. There was no statistically significant difference between any arm of UBX0101 and placebo at the 12-week endpoint for change from baseline in WOMAC-A, an established measurement of pain in OA. Given these results, UNITY does not anticipate progressing UBX0101 into pivotal studies and will narrow the company’s near-term focus to its ongoing ophthalmologic and neurologic disease programs.
“Osteoarthritis of the knee is a debilitating disease for many individuals,” said Jamie Dananberg, M.D., chief medical officer of UNITY. “While we are disappointed in the outcome of the 12-week results of the Phase 2 study of UBX0101, I would like to acknowledge our team’s hard work and commitment to executing a robust study that has provided clear results.”
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. The full results from the Phase 2 and Phase 1b studies will be presented at a future medical meeting.
Phase 2 12-week Data
In the Phase 2 double-blind, placebo-controlled study, 183 patients with moderate to severe painful OA of the knee were randomized to receive placebo, 0.5 mg, 2.0 mg or 4.0 mg of UBX0101 via a single intra-articular injection. The analysis results for the primary endpoint are shown in the table below.
| |
Primary Endpoint: Least Square Means Change from Baseline in WOMAC-A (0-4 scale) at Week 12 |
| Treatment |
WK 12 CFBL |
Pbo-Adjusted CFBL Wk 12 |
P-Value* |
| Placebo (N = 46) |
-1.017 |
N/A |
N/A |
| UBX0101 0.5 mg (N = 45) |
-0.924 |
0.093 |
0.5222 |
| UBX0101 2.0 mg (N = 46) |
-1.052 |
-0.035 |
0.8069 |
| UBX0101 4.0 mg (N = 46) |
-1.019 |
-0.002 |
0.9870 |
| |
|
|
|
|
* P-Value is obtained from MMRM testing CFBL against Placebo
UBX0101 was well-tolerated at all dose levels and adverse events (AEs) were consistent with previously reported data. There were no treatment-related serious AEs and only one patient discontinued because of an AE (for an unrelated cardiovascular event). The most common treatment emergent AE was procedural pain in the study knee (n = 10/183 (5.5%)).
“Developing novel treatments that selectively eliminate or modulate senescent cells is at the heart of what we do, and we have generated valuable data that will enable us to learn from this study and inform future studies in diseases of aging,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “While these are not the results we had hoped for, the evidence that senescent cells contribute to diseases of aging remains compelling, and we are excited to advance UBX1325 for retinal diseases, which inhibits Bcl-xL, a distinct senolytic target. Diabetic macular edema and diabetic retinopathy are attractive not only because of the strength of underlying biology, but also because of the sensitive, quantitative, and objective clinical assessments available. The burden of senescent cells in various diseases of aging is increasingly evident, which together with our research gives us great conviction in our science and the future of our pipeline.”
Additional information about the study can be found on www.clinicaltrials.gov (NCT04129944).
Financial Outlook
Based on current operating plans, UNITY believes that current cash, cash equivalents and investments are sufficient to fund operations well into 2022.
About UNITY
UNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. UNITY’s initial focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related diseases, such as osteoarthritis, eye diseases, neurological diseases and pulmonary diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.
SOURCE: Unity Biotechnology
Post Views: 33
