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Also known as TBPM-PI-HBr, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference, Tebipenem pivoxil hydrobromide- Reference, TBP-PI-HBr, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr), Tebipenem pivoxil hydrobromide, SPR994
Tebipenem HBr · 4 trials · 5 indications
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product.
Holter monitors will be used to collect continuous 12-lead electrocardiogram (ECG) data on Day 1. Triplicate 10-second, 12-lead ECG recordings will be extracted from the Holter monitor data within a 5-minute time window prior to the pharmacokinetic (PK) blood samples collected as close to the exact time point as possible
| Arm | Type | Description |
|---|---|---|
| TBP-PI-HBr | EXPERIMENTAL | Participants received TBP-PI-HBr 600 milligrams (mg), two x 300mg film-coated tablets, orally (PO) and a dummy infusion intravenously (IV), every 6 hours (q6h) from Day 1 through Day 10. Participants with estimated baseline creatinine clearance (CrCl) greater than (\>) 30 millilitres per minute (mL/min) and less than or equal to (≤) 50 mL/min received TBP-PI-HBr 300 mg q6h. |
| Imipenem-cilastatin | ACTIVE_COMPARATOR | Participants received imipenem-cilastatin 500 mg, IV and matched dummy tablets, PO, q6h from Day 1 through Day 10. Dose adjustments for imipenem-cilastatin were made for participants with estimated baseline CrCl less than (\<) 90mL/min per approved imipenem-cilastatin package insert. Participants with baseline CrCl levels greater than or equal to (≥) 60 to \< 90 mL/min were administered imipenem-cilastatin, 400 mg IV q6h and participants with baseline CrCl levels \>30 to \<60 mL/min, were administered 300mg IV, q6h. |
| TBPM-PI-HBr 600 mg | EXPERIMENTAL | TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \[q8h\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \[q24h\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \[CrCl\] \>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h. |
| Ertapenem 1 g | ACTIVE_COMPARATOR | Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency. |
| Treatment A | EXPERIMENTAL | 600 mg TBPM-PI-HBr (2 x 300 mg tablets) and TBPM-PI-HBr-matching placebo (2 x matching placebo tablets) administered at Hour 0 on Day 1. |
| Treatment B | EXPERIMENTAL | 1200 mg TBPM-PI-HBr (4 x 300 mg tablets) administered at Hour 0 on Day 1. |
| Treatment C | PLACEBO_COMPARATOR | TBPM-PI-HBr-matching placebo (4 x matching placebo tablets) administered at Hour 0 on Day 1. |
| Treatment D | OTHER | Positive Control - unblinded: 400 mg moxifloxacin (1 x 400 mg tablet) administered at Hour 0 on Day 1. |
| Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) | EXPERIMENTAL | Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally. |
| Name | Type | Description |
|---|---|---|
| TBP-PI-HBr | DRUG | TBP-PI-HBr film-coated immediate-release tablets. |
| Imipenem-cilastatin | DRUG | Sterile powder for reconstitution administered as IV. |
| Dummy Infusion | DRUG | 0.9% sodium chloride administered as IV infusion. |
| Dummy Tablets | DRUG | TBP-PI-HBr matching dummy tablets. |
| TBPM-PI-HBr | DRUG | TBPM-PI-HBr tablets administered orally. |
| Ertapenem | DRUG | Antibiotic Therapy for cUTI. |
| Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo | DRUG | Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo. |
| Moxifloxacin 400mg | DRUG | Treatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner. |
| Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) | OTHER | Treatment C: Subjects receive TBPM-PI-HBr matching placebo. |
| Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) | DRUG | Treatment B: Subjects receive TBPM-PI-HBr. |
Inclusion Criteria: 1. Have a diagnosis of cUTI or AP. 2. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following: 1. at least 10 white blood cells (WBCs) per high power field ...
Tebipenem HBr is an investigational oral antibiotic developed by Spero Therapeutics for treating complicated urinary tract infections and acute pyelonephritis. It is a small molecule drug in Phase 3 clinical development. It is designed to be taken orally, potentially offering an alternative to intravenous antibiotics for serious Gram-negative infections.
Tebipenem HBr is being developed to treat complicated urinary tract infections (cUTI) and acute pyelonephritis (AP) in adults. It is also being studied in patients with renal impairment. The drug is investigational and has not been approved by the FDA for any indication.
Tebipenem HBr is being developed by Spero Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SPRO. Spero Therapeutics is focused on developing treatments for multidrug-resistant bacterial infections and rare diseases.
Tebipenem HBr is in Phase 3 clinical development. The Phase 3 program includes a completed trial (NCT06059846) that evaluated oral Tebipenem HBr compared to intravenous imipenem-cilastatin in patients with complicated urinary tract infection or acute pyelonephritis. The drug is investigational and has not been approved by the FDA.
Tebipenem HBr has been studied in several clinical trials, including Phase 3 trials NCT06059846 and NCT03788967 in complicated urinary tract infection and acute pyelonephritis, and Phase 1 trials NCT04238195 (QT/QTc study) and NCT04178577 (renal impairment study). All listed trials are completed.
Yes, Tebipenem HBr is also known as SPR994, TBPM-PI-HBr, and tebipenem pivoxil hydrobromide. These names refer to the same investigational oral antibiotic developed by Spero Therapeutics for complicated urinary tract infections and acute pyelonephritis.