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...
Top 5 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 3 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
UBX0101 is being developed for the treatment of knee osteoarthritis, a degenerative joint condition. It is a small molecule administered to patients with osteoarthritis of the knee. Unity Biotechnology, Inc. is developing the drug, which has been studied in Phase 1 and Phase 2 clinical trials in the United States.
UBX0101 targets the p53/MDM2 protein interaction. By acting on this molecular target, the small molecule is designed to interfere with the p53 and MDM2 pathway. This target class is a protein interaction, distinguishing UBX0101 from treatments that act on other biological pathways in knee osteoarthritis.
UBX0101 is being developed by Unity Biotechnology, Inc., which trades on the Nasdaq under the ticker UBX. The company has sponsored all three of the clinical trials conducted with UBX0101 to date, all of which enrolled patients with osteoarthritis of the knee in the United States.
UBX0101 has completed Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 study, NCT04129944, evaluated a single dose of UBX0101 in patients with osteoarthritis of the knee and has been completed.
UBX0101 has been studied in three completed clinical trials: NCT04229225, a Phase 1 study of single and repeat dose administration; NCT04129944, a Phase 2 safety and efficacy study of a single dose; and NCT03513016, a Phase 1 safety and tolerability study. Together these trials enrolled 296 patients with knee osteoarthritis.
The UBX0101 clinical trials were randomized, double-blind, and controlled studies. All three trials, NCT04229225, NCT04129944, and NCT03513016, enrolled patients with knee osteoarthritis in the United States, with participants aged 40 years and older. Total enrollment across the completed trials was 296 patients.