Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JBT-101
Lenabasum · 3 trials · 2 indications
TIS from IMAC Core Set Measures (CSM) will be calculated following Aggarwal et al (2017) recommendations. Scores are based on a 0 - 100 scale; higher scores indicate better improvement in myositis.
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
| Arm | Type | Description |
|---|---|---|
| Lenabasum 20 mg | EXPERIMENTAL | Subjects will receive lenabasum 20 mg twice daily |
| Lenabasum 5 mg | EXPERIMENTAL | Subjects will receive lenabasum 5 mg twice daily |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive placebo twice daily |
| Lenabasum 20 mg BID | EXPERIMENTAL | - |
| Lenabasum 5 mg BID | EXPERIMENTAL | - |
| Placebo BID | PLACEBO_COMPARATOR | - |
| JBT101 (lenabasum) 1 mg | EXPERIMENTAL | JBT-101 1 mg once a day on Days 1-28 |
| JBT-101 (lenabasum) 5 mg | EXPERIMENTAL | JBT-101 5 mg once a day on Days 1-28 |
| JBT-101 (lenabasum) 20 mg QD | EXPERIMENTAL | JBT-101 20 mg once a day on Days 29-84. |
| JBT-101 (lenabasum) 20 mg BID | EXPERIMENTAL | JBT-101 20 mg twice daily on Days 29-84. |
| Name | Type | Description |
|---|---|---|
| Lenabasum 20 mg | DRUG | oral capsule |
| Lenabasum 5 mg | DRUG | oral capsule |
| Placebo | DRUG | oral capsule |
| JBT-101 (lenabasum) | DRUG | Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84. |
Inclusion Criteria: * Fulfill at least one of the following criteria for dermatomyositis: 1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b) 2. ACR/EULAR criteria (Lundberg et al, 2017) * Disease activity/severity fulfills at least one of the following three criteria: ...
Lenabasum is an investigational small molecule developed by Corbus Pharmaceuticals Holdings, Inc. (ticker CRBP). It has been studied in clinical trials for cystic fibrosis and dermatomyositis, a rare inflammatory muscle disease. It is not described as an approved therapy and remains in clinical development.
Lenabasum has been evaluated as a treatment for cystic fibrosis and dermatomyositis. A Phase 2 trial in cystic fibrosis enrolled 447 participants, and a Phase 3 trial in dermatomyositis enrolled 176 participants. Both studies are completed, and the drug is investigational rather than an approved treatment for either condition.
Lenabasum is developed by Corbus Pharmaceuticals Holdings, Inc., which trades under the ticker CRBP. The company sponsored the clinical trials evaluating the drug in cystic fibrosis and dermatomyositis.
Lenabasum has been tested in a Phase 2 trial in cystic fibrosis and a Phase 3 trial in dermatomyositis. Both trials are completed, and no trials are currently active. The drug is investigational and has not been established as an approved therapy.
Lenabasum was studied in NCT03451045, a completed Phase 2 trial in cystic fibrosis that enrolled 447 participants, and NCT03813160, a completed Phase 3 trial in dermatomyositis that enrolled 176 participants. Both were randomized, double-blind, placebo-controlled studies conducted across multiple countries.