Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NCO-48 · 2 trials · 2 indications
Time-weighted average change from baseline through Week 4 in plasma HBV DNA (log10 IU/mL) for NCO-48 Fumarate 4 and 20-mg.
An adverse event is defined as any untoward medical occurrence in a clinic investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 30 days post dose.
| Arm | Type | Description |
|---|---|---|
| NCO-48 Fumarate 4 mg | EXPERIMENTAL | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| NCO-48 Fumarate 20 mg | EXPERIMENTAL | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| Tenofovir alafenamide 25 mg | ACTIVE_COMPARATOR | Eligible subjects will be randomized 1:1:1 to receive either open-label NCO-48 Fumarate 4 mg or 20 mg, or open-label TAF 25 mg for 28 days. |
| NCO-48 Fumarate | EXPERIMENTAL | NCO-48 Fumarate |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator |
| Name | Type | Description |
|---|---|---|
| NCO-48 Fumarate 4 mg | DRUG | 2 x 2mg NCO-48 Fumarate over 28 days of therapy |
| NCO-48 Fumarate 20 mg | DRUG | 2 x 10 mg NCO-48 Fumarate over 28 days of therapy |
| Tenofovir Alafenamide 25 mg | DRUG | 25 mg over 28 days of therapy |
| NCO-48 Fumarate | DRUG | NCO-48 Fumarate |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Adult male and female subjects between 18 and 65 years of age * Female subjects of non-childbearing potential must be surgically sterile or postmenopausal at the Screening Visit * Female subjects of childbearing potential who are sexually active with a non-sterile male partner...
NCO-48 is an investigational small molecule being developed for the treatment of Hepatitis B and Chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by the FDA.
NCO-48 is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LGND.
NCO-48 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy subjects and one in treatment-naive adults with chronic Hepatitis B. It is not yet FDA approved.
NCO-48 has been studied in two completed Phase 1 trials: NCT04309526, a safety, tolerability and pharmacokinetics study in healthy subjects, and NCT04629976, an activity study in treatment-naive adults with chronic Hepatitis B.
Yes, NCO-48 is also known as NCO-48 Fumarate. Clinical trials have evaluated the fumarate salt form of the drug, and both names refer to the same investigational compound.