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...
Top 8 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE3 | BNT162b2 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
C21 is an investigational small molecule being studied for COVID-19, idiopathic pulmonary fibrosis, type 2 diabetes, and Raynaud phenomenon. It has also been evaluated for its vasodilatory effects. Clinical trials have been conducted in these conditions, with the most advanced studies in COVID-19 and IPF.
C21 is being developed by Vicore Pharma Holding AB, a biopharmaceutical company. The company's American Depositary Shares trade under the ticker VCRE. Vicore has sponsored clinical trials of C21 across multiple indications.
C21 is in Phase 3 clinical development. A Phase 3 trial of C21 in COVID-19 has been completed. Earlier Phase 2 trials in COVID-19 and idiopathic pulmonary fibrosis have also been completed, along with a Phase 1 trial in type 2 diabetes.
C21 has been studied in several completed trials. NCT04880642 is a Phase 3 trial in COVID-19 with 272 participants. NCT04452435 is a Phase 2 COVID-19 trial with 206 participants. NCT04533022 is a Phase 2 IPF trial with 52 participants, and NCT05831644 is a Phase 1 type 2 diabetes trial with 11 participants.
C21 is the drug candidate developed by Vicore Pharma Holding AB. The company has sponsored all clinical trials of C21, including those in COVID-19, IPF, and type 2 diabetes. C21 is the investigational compound being evaluated in these studies.