Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lenabasum · 2 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 | - |
| Name | Type | Description |
|---|---|---|
| Lenabasum 20 mg | DRUG | oral capsule |
| Lenabasum 5 mg | DRUG | oral capsule |
| Placebo | DRUG | oral capsule |
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 being studied for the treatment of dermatomyositis and cystic fibrosis. It is being developed by Corbus Pharmaceuticals Holdings, Inc. (CRBP). The drug is currently in clinical development, with trials conducted in patients with these conditions.
Lenabasum is a small molecule that targets the cannabinoid receptor type 2 (CB2). By activating CB2, it is designed to modulate the immune response and reduce inflammation. This mechanism is being evaluated in clinical trials for dermatomyositis and cystic fibrosis.
Lenabasum is being developed by Corbus Pharmaceuticals Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRBP. The company is conducting clinical trials to evaluate the safety and efficacy of Lenabasum in patients with dermatomyositis and cystic fibrosis.
Lenabasum is in Phase 2 clinical development for cystic fibrosis and Phase 3 clinical development for dermatomyositis. Both trials have been completed. The drug is investigational and has not been approved by regulatory authorities for any indication.
Lenabasum has been evaluated in two completed clinical trials. NCT03451045 was a Phase 2 trial in cystic fibrosis with 447 participants, conducted across multiple countries including the United States and European nations. NCT03813160 was a Phase 3 trial in dermatomyositis with 176 participants, also conducted internationally.
Lenabasum is also known by its chemical name, JBT-101. It is a synthetic small molecule that acts as an agonist of the cannabinoid receptor type 2. This compound is being investigated for its potential to treat inflammatory and fibrotic diseases.