Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-TVB-2640
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 |
|---|---|---|
| TVB-2640 50 mg | EXPERIMENTAL | Subjects will receive TVB-2640 PO QD for 52 weeks, with the first dose administered on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive matching placebo 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 |
| Treatment Arm 1 | EXPERIMENTAL | Single dose of TVB-2640, 50 mg, oral administration |
| Name | Type | Description |
|---|---|---|
| TVB-2640 | DRUG | Oral dose, tablet |
| Placebo | OTHER | 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 |
| [14C]-TVB-2640 | DRUG | 50 mg of TVB-2640 oral administration |
Inclusion Criteria: * Must be willing and able to participate in the study and provide written informed consent. * Male and female adults ≥18 years of age on the date that written informed consent to take part in the study is provided. * Body mass index (BMI) ≥23 kg/m2 for Asians and ≥25 kg/m2 for ...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
TVB-2640 is an investigational small molecule drug developed by Sagimet Biosciences Inc. (ticker: SGMT). It has been studied in healthy volunteers and in patients with conditions including non-alcoholic steatohepatitis, MASLD/MASH, hepatic impairment, cirrhosis, KRAS gene mutation, and solid malignant tumors. It is not approved and remains in clinical development.
TVB-2640 targets FASN, an enzyme involved in fatty acid synthesis. By inhibiting this enzyme, the drug is designed to affect lipid production, which is relevant to liver conditions such as non-alcoholic steatohepatitis and MASLD/MASH, as well as to solid tumors with KRAS gene mutation.
TVB-2640 is developed by Sagimet Biosciences Inc., which trades under the ticker SGMT. The company is listed as the developer of the drug across its clinical program.
TVB-2640 is in Phase 1 development according to the current program status. It is an investigational drug and has not been approved by the FDA. Phase 2 studies have also been completed in non-alcoholic steatohepatitis and MASLD/MASH, but the drug remains in clinical development.
TVB-2640 has been studied in completed trials including NCT05835180, a Phase 1 pharmacokinetic study in hepatic impairment; NCT05657834, a Phase 1 absorption, metabolism, and excretion study in healthy males; NCT04906421, a Phase 2 NASH study; and NCT03938246, a Phase 2 NASH study.
Yes, TVB-2640 is also known as denifanstat. Other alternative names include TVB-2640 - 50 mg, [14C]-TVB-2640, and TVB-2640 25 mg (US). These refer to the same investigational compound developed by Sagimet Biosciences.