Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UBX0101 · 3 trials · 2 indications
WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| UBX0101 0.5 mg | EXPERIMENTAL | - |
| UBX0101 2.0 mg | EXPERIMENTAL | - |
| UBX0101 4.0 mg | EXPERIMENTAL | - |
| UBX0101 single dose (SD) | EXPERIMENTAL | Cohort 1 (n=18): UBX0101 8.0 mg or placebo IA at Week 0 Patients will be randomized in a 2:1 ratio to UBX0101 and placebo |
| UBX0101 repeat dose (RD) | EXPERIMENTAL | Cohort 2 (n=18): UBX0101 4.0 mg or placebo IA at Weeks 0 and 4 Patients will be randomized in a 2:1 ratio to UBX0101 and placebo |
| Part A: UBX0101 | EXPERIMENTAL | Part A: UBX0101, single intra-articular injection, ascending dose |
| Part A: Placebo | PLACEBO_COMPARATOR | Part A: Placebo, single intra-articular injection, ascending dose |
| Part B: UBX0101 | EXPERIMENTAL | Part B: UBX0101, single intra-articular injection, fixed dose |
| Part B: Placebo | PLACEBO_COMPARATOR | Part B: Placebo, single intra-articular injection, fixed dose |
| Name | Type | Description |
|---|---|---|
| UBX0101 | DRUG | Investigational drug intra-articular injection |
| Placebo | OTHER | Placebo intra-articular injection |
Key Inclusion Criteria: * Patients who are ambulatory with a diagnosis of OA of the knee and who have baseline pain with a mean of ≥ 4 and ≤ 9 on the 11-point (0-10) average daily pain NRS for at least five of seven days during the Screening period. * Kellgren-Lawrence grade of 1-4 on a weight-bear...
UBX0101 is an investigational small molecule being developed for the treatment of osteoarthritis of the knee. It is designed to address the underlying cellular mechanisms of the disease, though the specific molecular target has not been disclosed. The drug is administered as a single dose or repeat doses directly into the knee joint.
UBX0101 is being developed by Unity Biotechnology, Inc., a company traded on the NASDAQ under the ticker symbol UBX. The company is focused on developing therapies that target age-related diseases, including osteoarthritis.
UBX0101 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials assessed safety and tolerability, while the Phase 2 trial evaluated safety and efficacy of a single dose. All three trials are completed, and the drug remains investigational, not yet approved by regulatory authorities.
UBX0101 has been studied in three completed clinical trials: NCT03513016 (Phase 1, safety and tolerability, 78 patients), NCT04129944 (Phase 2, safety and efficacy of a single dose, 183 patients), and NCT04229225 (Phase 1, single and repeat dose administration, 35 patients). All trials were conducted in the United States.
No alternative names for UBX0101 have been disclosed. It is identified solely by its compound designation UBX0101 in clinical trial registries and scientific literature. No other brand or generic names are associated with this investigational drug.