Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VGX-410 (Mifepristone)
VGX-410 · 2 trials · 2 indications
Mean log change in HIV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.
Mean log change in HCV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) following once or twice daily dosing for 28 days at the 28 day timepoint
| Arm | Type | Description |
|---|---|---|
| VGX-410 (Mifepristone) | ACTIVE_COMPARATOR | 150mg twice daily of VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of VGX-410 for 14 days |
| Placebo for VGX-410 (Mifepristone) | PLACEBO_COMPARATOR | 150mg twice daily of placebo for VGX-410 for 14 days and, if well tolerated, a dose escalation to 300mg twice daily of placebo for VGX-410 for 14 days |
| Placebo | PLACEBO_COMPARATOR | - |
| 150 mg daily | ACTIVE_COMPARATOR | - |
| 300mg daily | ACTIVE_COMPARATOR | - |
| 300mg twice daily | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VGX-410 (Mifepristone) | DRUG | - |
| Placebo for VGX-410 (Mifepristone) | DRUG | - |
| Placebo | DRUG | Placebo for VGX-410 tablets taken daily or twice daily for 28 days |
Inclusion Criteria: * HIV-1 infection * CD4 cell count \> 200 * Plasma HIV-1 RNA \> 2000 copies/mL and have not received antiretroviral therapy within the 16 weeks prior to entry * Absolute neutrophil count \> 750/mm3 * Hemoglobin \> 10 g/dL * Platelet count \> 100,000 mm3 * Creatinine \< 2 X upper...
Top 18 of 28 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 5 | PHASE3 | VLA15, ATM-AVI, PG4, Prevenar 20 |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 2 | PHASE3 | DefenCath, Meropenem-Vaborbactam |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
VGX-410 is an investigational small molecule developed by Inovio Pharmaceuticals, Inc. (ticker INO) for infectious disease. It has been studied in Phase 2 clinical trials for HIV Infections and Hepatitis C Virus Infection. It is also known as mifepristone. VGX-410 has not been approved by the FDA and remains in clinical development.
VGX-410 was studied for the treatment of HIV Infections. A Phase 2 trial, NCT00352911, titled Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects, evaluated the drug in 19 participants in the United States. That trial is completed. VGX-410 is investigational and is not approved for any use.
VGX-410 was studied for Hepatitis C Virus Infection. A Phase 2 trial, NCT00255177, titled Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients, enrolled 44 participants in the United States, including healthy volunteers. That trial is completed. VGX-410 remains investigational and is not approved for any indication.
VGX-410 is developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. Inovio is the sponsor associated with the clinical development of VGX-410 for HIV Infections and Hepatitis C Virus Infection. The program has been studied in Phase 2 trials that are now completed.
VGX-410 is in Phase 2. Both of its clinical trials were Phase 2 studies, and both are completed, with no active trials ongoing. VGX-410 is an investigational drug and has not been approved by the FDA. It was studied for HIV Infections and Hepatitis C Virus Infection.
VGX-410 has been evaluated in two completed Phase 2 trials. NCT00352911 tested two doses of mifepristone in 19 HIV-1 infected subjects. NCT00255177 tested three doses in 44 Hepatitis C infected patients, including healthy volunteers. Both trials were conducted in the United States and are completed, with no active trials reported.
Yes. VGX-410 is also known as mifepristone. The clinical trials for this program are listed under the name mifepristone, including NCT00352911 in HIV-1 infected subjects and NCT00255177 in Hepatitis C infected patients. Inovio Pharmaceuticals, Inc. (ticker INO) is the developer associated with VGX-410.