Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TP-271 · 4 trials · 2 indications
Incidence, intensity, and type of adverse events (AEs) from the time of signing the informed consent form (ICF) through the EOS Visit
Changes in physical examination findings between Day -1 and the EOS Visit
Changes in vital signs from Day -1 through the EOS Visit
Changes in safety laboratory (clinical chemistry, electrolytes, hematology, blood glucose, and coagulation) results from Day -1 through the EOS Visit
Changes in electrocardiogram (ECG) measurements from Day -1 through the EOS Visit
changes in physical examination findings for chest/respiratory
Changes in Physical Examination including heart/cardiovascular
Changes in Pulse Rate
Changes in respiration rate
Changes in body temperature
Changes in blood pressure
Changes in PR interval \> or=20
Changes in QRS interval\> or=10
Changes in QTcF interval 30 to 60, \> or =60
Changes in safety laboratory results including clinical chemistry
Changes in safety laboratory results including electrolytes
Changes in safety laboratory results including hematology
Changes in Safety laboratory results including glucose
Changes in Safety Laboratory results including coagulation
The incidence, intensity, and type of adverse events (AE) and the total number of participants experiencing AEs that are related to treatment Outcome measures to be collected in support of the primary objective (safety and tolerability) include: * The incidence, intensity, and type of AEs (from time of signing of informed consent form \[ICF\] through EOS); * Changes in physical examination findings (Day -1 and EOS); * Changes in vital signs (Day -1 through EOS); * Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results (Days -1 through EOS); and * Changes in ECG measurements (Days -1 through EOS).
Changes in safety laboratory (chemistry, hematology, coagulation, urinalysis) results that are considered abnormal, clinically significant and related to treatment
| Arm | Type | Description |
|---|---|---|
| Cohort A | ACTIVE_COMPARATOR | Multiple IV doses of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 0.5 mg/kg once daily for 7 days, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort B | ACTIVE_COMPARATOR | Multiple IV doses of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 1.0 mg/kg once daily for 7 days, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort C | ACTIVE_COMPARATOR | Multiple IV doses of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 2.0 mg/kg once daily for 7 days, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort D | ACTIVE_COMPARATOR | Multiple IV doses of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 2.5 mg/kg once daily for 7 days, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort E | ACTIVE_COMPARATOR | Multiple IV doses of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 3.0 mg/kg once daily for 7 days, 60 minute infusion or Placebo - sterile 0.45% saline for 60 minute IV infusion |
| Cohort F | ACTIVE_COMPARATOR | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 300 mg single dose (n = 6) or matching placebo (n = 2) |
| Cohort G | ACTIVE_COMPARATOR | Oral dose of TP-271, a novel, broad-spectrum tetracycline-class antibiotic, 50 mg TP 271, cross-over to 50 mg TP 271/250 mg EDTA (n = 3); 50 mg TP 271/250 mg EDTA, cross-over to 50 mg TP 271 (n = 3); matching placebo, cross over to 250 mg EDTA (n= 1); or 250 mg EDTA, cross over to matching placebo (n = 1) |
| Name | Type | Description |
|---|---|---|
| TP-271 | DRUG | multiple oral doses of TP-271 or placebo, dosed once daily for 7 days, randomized 3:1, doses escalating as 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 2.5 mg/kg, and 3.0 mg/kg |
| Placebo | DRUG | Placebo is sterile 0.45% saline randomized 3:1 to receive |
Inclusion Criteria: 1. Be within the age range of 18 to 50 years, inclusive, at the time of Screening 2. Voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved ICF to participate in the study after all relevant aspects of the study have been explained and d...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| 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 |
TP-271 is an investigational small molecule antibiotic being developed by Innoviva, Inc. for bacterial infections, including pneumonia. It is in Phase 1 clinical development. Because it is still in early-stage testing, TP-271 is not an approved medicine and is available only to participants enrolled in its clinical trials.
TP-271 is being studied for the treatment of bacterial infections, including pneumonia. Its clinical program has evaluated the drug in healthy adult volunteers rather than patients, so its use in treating active infections remains investigational. No approved indication exists for TP-271 at this stage of development.
TP-271 is developed by Innoviva, Inc., which trades on the Nasdaq under the ticker INVA. Innoviva is the sponsor of the clinical program evaluating the drug. The company holds the asset as part of its infectious disease pipeline.
TP-271 is in Phase 1 clinical development. All of its reported trials are Phase 1 studies, and all have been completed. The program has not advanced beyond early-stage testing, so TP-271 remains an investigational drug rather than an approved therapy.
TP-271 has been evaluated in four Phase 1 trials: NCT03450187, an oral multiple ascending dose study; NCT03234738, an intravenous safety and pharmacokinetics study; NCT03024034, an oral single ascending dose study; and NCT02724085, an intravenous safety, tolerability and pharmacokinetics study in pneumonia. All are completed.
Across its completed Phase 1 program, TP-271 trials have enrolled a total of 193 participants. The studies were randomized, double-blind, and actively controlled, and they enrolled healthy adult volunteers aged 18 years and older in the United States. Enrollment figures come from the individual trial records.