Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Allocetra-OTS · 3 trials · 8 indications
Change from baseline in SOFA score throughout 28 days
Number and severity of AEs and SAEs throughout 28 days follow up period
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
The safety and tolerability endpoint evaluates the incidence and severity of complications following intraarticular injection of Allocetra-OTS: * Injection-related reactions occurring during Allocetra-OTS injection, including injection interruption/discontinuation. * Treatment-emergent adverse events following Allocetra-OTS injection. * Treatment-emergent serious adverse events. * Adverse events or serious adverse events related to the use of Allocetra-OTS as an intraarticular injection material. * Safety assessments beyond 1 month following injection will focus on events that are at least possibly related to Allocetra-OTS treatment.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | PLACEBO_COMPARATOR | Single IV dose of placebo solution |
| Cohort 2 | EXPERIMENTAL | Single IV dose of 5x10\^9 Allocetra-OTS cells in suspension |
| Cohort 3 | EXPERIMENTAL | Single IV dose of 10x10\^9 Allocetra-OTS cells in suspension |
| Cohort 4 | EXPERIMENTAL | Single or two doses of 10x10\^9 Allocetra-OTS cells in suspension |
| Allocetra-OTS | EXPERIMENTAL | Standard of Care (SOC) Drug: One dose Allocetra-OTS 140 140x106 /kg |
| Allocetra-OTS Two doses | EXPERIMENTAL | Standard of Care (SOC) Drug: Two doses Allocetra-OTS 140 140x106 /kg |
| Name | Type | Description |
|---|---|---|
| Allocetra-OTS | DRUG | Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO. |
| Placebo | OTHER | Solution containing all excipients except for the Allocetra-OTS cells |
Inclusion Criteria: 1. Male or female ≥18 years and ≤90 years of age. 2. Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status 3. Sepsis due to infection in at least one of the below organs: 3.1. Community-Acquired Pneumonia (CAP). 3.2. Urinary tract infection 3.3. Acute chole...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |
Allocetra-OTS is an investigational small molecule being studied for sepsis, organ dysfunction syndrome related to sepsis, and knee osteoarthritis. It is being developed by Enlivex Ltd. (ENLV) and is currently in clinical trials, including early phase studies for these conditions.
Allocetra-OTS is a small molecule immunomodulator that targets apoptotic cell clearance pathways to restore immune homeostasis. It is designed to reprogram macrophages from a pro-inflammatory to an anti-inflammatory state, which may help in conditions like sepsis and osteoarthritis.
Allocetra-OTS is being developed by Enlivex Ltd., a clinical-stage biopharmaceutical company. The company is publicly traded under the ticker symbol ENLV.
Allocetra-OTS is in early clinical development. It has completed Phase 1 and Phase 2 trials for sepsis-related organ dysfunction, and an early Phase 1 trial for knee osteoarthritis is active but not recruiting. It is not yet approved by the FDA.
Allocetra-OTS has been studied in several clinical trials. NCT03925857 was a Phase 1 trial for sepsis-related organ dysfunction. NCT04612413 was a Phase 2 trial for sepsis. NCT06208241 is an early Phase 1 trial for knee osteoarthritis, which is active but not recruiting.
Allocetra-OTS is a distinct investigational drug developed by Enlivex. It is not known to be the same as any other approved or investigational product under a different name.