Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
C21 · 6 trials · 7 indications
Proportion of subjects in the mITT (all randomised, including 5 subjects not treated) with death up to Day 60 follow-up
Number of participants with adverse events occurring over the trial period incl. number of participants with any TEAE, serious TEAEs, TEAEs leading to withdrawal from trial, TEAEs leading to discontinuation of treatment, treatment-related TEAEs leading to discontinuation of treatment, TEAEs leading to death, and serious treatment-related TEAEs. Adverse events were recorded from signing of informed consent until end of trial. Nature and frequency of adverse events are presented in details in the adverse events section.
Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period
Area under the curve for rewarming of each finger after cold challenge as measured by thermography for 15 min
Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). The EndoPAT software, provided with the device, is calculating the RHI using a computerised, automated algorithm. Reactive Hyperemia Index (RHI) score is a post-to-pre occlusion pulse amplitude tonometry signal ratio in the occluded arm relative to the same ratio in the control arm, and corrected for baseline vascular tone. RHI is a measure of endothelial function. Normal value: RHI \> 1.67. Abnormal value: RHI ≤ 1.67. There is no theoretical minimum and/or maximum values for the RHI score. A lower RHI score following C21 compared to placebo is the desired outcome.
Percentage change from baseline in forearm blood flow (FBF) in response to increasing intraarterial doses of C21 (3, 10, 30, 100, and 200 μg/min)
| Arm | Type | Description |
|---|---|---|
| C21 | EXPERIMENTAL | 50 mg capsules, oral administration twice daily,for 14 days |
| Placebo | PLACEBO_COMPARATOR | placebo capsules, oral administration twice daily,for 14 days |
| C21 100 mg twice daily | EXPERIMENTAL | Oral C21 treatment 100 mg twice daily for 7 days |
| C21 followed by placebo | EXPERIMENTAL | - |
| Placebo followed by C21 | EXPERIMENTAL | - |
| Treatment arm 1 | EXPERIMENTAL | A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3. |
| Treatment arm 2 | EXPERIMENTAL | A single dose of placebo at visit 2 followed by a single dose C21 at visit 3. |
| C21 combined | EXPERIMENTAL | 15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min) |
| Positive control | EXPERIMENTAL | 4 µg nitroprusside (infusion rate 0.8 µg/min) 8 µg nitroprusside (infusion rate 1.6 µg/min) 16 µg nitroprusside (infusion rate 3.2 µg/min) |
| Name | Type | Description |
|---|---|---|
| C21 | DRUG | C21 |
| Placebo | DRUG | Placebo |
| Sodium Nitroprusside | DRUG | Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control |
Inclusion Criteria: 1. Age ≥18 years or the legal age of consent in the jurisdiction in which the trial was taking place at the time of signing the informed consent (Specific for India; Age ≥18 to ≤65 years at the time of signing the informed consent) 2. Hospitalized due to SARS-CoV-2 infection con...
C21 is an investigational small molecule being studied for several conditions, including COVID-19, idiopathic pulmonary fibrosis, Raynaud phenomenon, type 2 diabetes, and endothelial dysfunction. It has been evaluated in clinical trials for its safety, efficacy, and vasodilatory effects. The drug is not approved and remains in clinical development.
C21 is being developed by Vicore Pharma Holding AB, a biopharmaceutical company listed on the stock exchange under the ticker VCRE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various patient populations.
C21 is currently in Phase 3 clinical development. It has completed Phase 2 trials for COVID-19 and idiopathic pulmonary fibrosis, as well as Phase 1 trials for vasodilatory effects and type 2 diabetes. The drug is investigational and has not been approved by regulatory authorities.
C21 has been studied in several completed clinical trials, including NCT04452435 for COVID-19, NCT04533022 for idiopathic pulmonary fibrosis, NCT05277922 for vasodilatory effects, and NCT05831644 for type 2 diabetes and endothelial dysfunction. These trials were randomized, double-blind, and placebo-controlled.
C21 is a distinct investigational drug developed by Vicore Pharma. It is not the same as other drugs in the company's pipeline. The drug has been evaluated in clinical trials for multiple indications, including COVID-19 and idiopathic pulmonary fibrosis, and is currently in Phase 3 development.