Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
STI-1558 · 1 trial · 1 indication
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5) Safety as assessed by incidence of adverse events, clinically significant changes in safety lab results, physical exam, vital signs, and electrocardiogram
Heart function as assessed by 12-lead electrocardiogram
| Arm | Type | Description |
|---|---|---|
| STI-1558 | EXPERIMENTAL | Subjects will receive in each part either a single ascending dose (SAD): 300 mg, 600 mg, 1200 mg, 2000 mg on Day1 or as part of the multiple ascending dose (MAD): 300 mg, 600 mg, and 800 mg twice a day for 7.5 days |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive placebo orally following either the SAD or MAD dosing schedule |
| Name | Type | Description |
|---|---|---|
| STI-1558 | DRUG | Orally available protease inhibitor capsule |
| Placebo | DRUG | Placebo product capsule |
Inclusion Criteria: * Body mass index (BMI) is between 18 and 30 kg/m2 (both inclusive), and Body weight between 45 and 100 kg (inclusive) * Generally normal, or abnormal with no clinical significance as judged by the primary investigator based on physical examination, vital signs, electrocardiogra...
Top 9 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 8 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 3 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Vaxart | VXRT | 1 | PHASE2 | VXA-CoV2-3.1, VXA-CoV2-3.3 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |