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Also known as [14C]-TVB-2640, denifanstat
TVB-2640 · 6 trials · 8 indications
Histological improvement is defined as ≥2 points improvement in NAS with ≥1 point improvement in ballooning or inflammation
NASH resolution defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a score of either 0 or 1 for inflammation, 0 for ballooning and any value for steatosis and no worsening of liver fibrosis (by NASH CRN fibrosis score). Histological improvement defined as ≥2 point improvement in NAS (with ≥1 point improvement in ballooning or inflammation).
Determine Disease control rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Determine response rate of TVB-2640 in KRAS mutant NSCLC patients through RECIST and toxicity profile. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), \>=20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
As determined by MRI-PDFF
Total TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Unbound TVB-2640 plasma concentration-time curve during a dosing interval at steady-state
Toxicity will be monitored according to NCI - Common Toxicity Criteria for Adverse Events version (4.03). Patients receiving at least one dose of drug.
| Arm | Type | Description |
|---|---|---|
| Denifanstat | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| TVB-2640 50 mg | EXPERIMENTAL | Subjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1. |
| TVB-2640 | EXPERIMENTAL | Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks. |
| TVB-2640 25 mg (US) | EXPERIMENTAL | Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). |
| TVB-2640 50 mg (US) | EXPERIMENTAL | Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). |
| Placebo (US) | PLACEBO_COMPARATOR | Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640. |
| TVB-2640 50 mg (China) | EXPERIMENTAL | Subjects randomly assigned to receive the study drug will take TVB-2640 tablet orally every day for 12 week treatment period. The dose is to be taken at the same time of the day, with each dose separated by 24 hours (±4 hours). |
| Placebo (China) | PLACEBO_COMPARATOR | Subjects randomly assigned to placebo will receive placebo tablets orally once a day under the same conditions and frequency as described for TVB-2640. |
| TVB-2640 75 mg (US) | EXPERIMENTAL | After completion of Cohorts 1 and 2, and if no stopping criteria are met upon review by the Independent SRC, an additional TVB-2640 75 mg open-label Cohort 3 will open in the US |
| TVB-2640 50 mg - normal hepatic function | EXPERIMENTAL | Healthy subjects with normal hepatic function receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - mild hepatic function | EXPERIMENTAL | Subjects with mild hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - moderate hepatic function | EXPERIMENTAL | Subjects with moderate hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| TVB-2640 50 mg - severe hepatic function | EXPERIMENTAL | Subjects with severe hepatic impairment will receive 50 mg PO daily from Day 1 to Day 4 |
| Name | Type | Description |
|---|---|---|
| Denifanstat | DRUG | Oral, once daily |
| Placebo | OTHER | Oral, once daily |
| TVB-2640 | DRUG | Oral dose, tablet |
| TVB-2640 25 mg (US) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 50 mg (US) | DRUG | Oral dose, tablet, daily dosing |
| Placebo (US) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 50 mg (China) | DRUG | Oral dose, tablet, daily dosing |
| Placebo (China) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 75 mg (US) | DRUG | Oral dose, tablet, daily dosing |
| TVB-2640 - 50 mg | DRUG | TVB-2640 -50 mg administered orally once daily |
Inclusion Criteria: 1. Must be willing and able to participate in the trial and provide written informed consent or assent 2. Aged ≥12 years on the date that written informed consent/ assent is provided 3. Moderate to severe acne vulgaris based on the following criteria at screening: 1. The EGS...
TVB-2640 is an investigational small molecule developed by Sagimet Biosciences Inc. (ticker SGMT). It is being studied in Phase 2 clinical development across liver disease and oncology indications, including MASLD/MASH (metabolic dysfunction-associated steatotic liver disease and steatohepatitis) and KRAS-mutant solid tumors. It is also known as denifanstat.
TVB-2640 is being evaluated for MASLD/MASH, also called nonalcoholic steatohepatitis or NASH, and for KRAS gene mutation solid malignant tumors, including KRAS non-small cell lung carcinoma. It is investigational and has not been approved for any indication.
TVB-2640 targets FASN, fatty acid synthase, an enzyme involved in fatty acid synthesis. By inhibiting this enzyme, the drug is designed to act on lipid production pathways relevant to both liver disease and tumor biology. FASN is the molecular target studied in its clinical program.
TVB-2640 is developed by Sagimet Biosciences Inc., which trades under the ticker SGMT. The company is the sponsor of the clinical studies evaluating the drug in liver disease and oncology indications.
TVB-2640 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Its clinical program includes completed Phase 2 studies in NASH and MASLD/MASH and an active Phase 2 study in KRAS non-small cell lung carcinoma.
TVB-2640 has been studied in NCT04906421, a completed Phase 2 trial in NASH, NCT03938246, a completed Phase 2 trial in MASLD/MASH, NCT03808558, an active Phase 2 trial in KRAS non-small cell lung carcinoma, and NCT05835180, a completed Phase 1 pharmacokinetic study in hepatic impairment.
Yes, TVB-2640 is also known as denifanstat. Other names used for the drug in study records include TVB-2640 50 mg, [14C]-TVB-2640, and TVB-2640 25 mg (US). These refer to the same investigational FASN inhibitor developed by Sagimet Biosciences.