The efficacy is comparable to the intravenous Erthaman! Tebipenem HBr treatment cUTI Phase III clinical success.

Spero Therapeutics is committed to the development and commercialization of drugs to treat multidrogen-resistant (MDR) bacterial infections and rare diseases.
recently, the company announced positive top-line results for evaluating oral antibiotic tebipenem HBr (Tebipenan hydrobromobromates, formerly known as SPR994) for the treatment of complex urinary tract infections (cUTI) and acute pyelonephritis (AP) in adult patients with critical stage III ATAPT-PO.
data show that oral tebipenem HBr is statistically not as effective as intravenous ertapenem.
ADAPT-PO is a global, randomized, placebo-controlled trial that evaluates the safety and effectiveness of tebipenem HBr in treating adult patients with cUTI and AP.
trial, patients were randomly assigned (1:1) to tebipenem HBr (600 mg, oral, every 8 hours) and Ertepenan (1g, intravenously, every 24 hours) for a total of 7-10 days of treatment.
patients with bacteriobacterialemia receive treatment for up to 14 days.
the main endpoints are: in the micro-ITT population, the comprehensive response rate (ORR) at the time of the TOC visit (day 19-2) is defined as clinical cure and pathogenic microbial eradication.
results showed that the ORR in the tebipenem HBr treatment group was 58.8% (264/449) and the ORR in the Erthapenan treatment group was 61.6% (258) /419) (Treatment difference: -3.3%; 95% CI: -9.7, 3.2; non-inferior .NI limit -12.5%).
the clinical cure rate was higher during the TOC visits of the two treatment groups.
ORR was consistent in key subgroups (including age, baseline diagnosis, presence of mycobacteria), and the study reached the main endpoint.
the pathogenic microbial responses of the most common urinary pathogens were balanced among the treatment groups.
comparative safety analysis of 1,372 hospitalized adult patients in the group trial showed that tebipenem HBr had good tolerance and similar safety to Erthapenan.
2 groups, about 26% of patients experienced adverse events (TEAE) during treatment, with the most common TEAE being diarrhea (5.0%) and headache (3.8%).
severe TAAE was not common (1.3 per cent in the tebipenem HBr group and 1.7 per cent in the Ertepenan group) and no deaths were reported in the trial.
3 cases of TAAE associated with Ocythrobacteria were observed in the Otaman group, but not in the tebipenem HBr group.
chemical structure of tebipenan esters (Photo: medchemexpress.com) Tebipenem HBr is a new oral preparation for tebipenem pivoxil.
tippenanester is a beta-endamide-type carbon penicillin antibiotic sold in Japan since 2009 under the brand name Orapenem by Meiji Fruit Pharmaceuticals of Japan for the treatment of pediatric infections limited to pneumonia, otitis media and sinusitis.
an important class of antibiotics, which are safe and effective in treating drug-resistant Terrain-negative infections.
Spero Therapeutics expects that once the results of the ADAPT-PO clinical trial are finalized, a new drug application to the FDA will be completed in the second quarter of 2021.
approved, tebipenem HBr would be the first oral penicillin antibiotic to be licensed in the United States.
, tebipenem HBr was awarded qualified infectious disease products (QIDP) and fast-track qualification (FTD) for the treatment of cUTI and AP by the FDA.
because of the increasing prevalence of antibiotic resistance, many cUTI patients now receive intravenous antibiotics as their only treatment option.
ADAPT-PO is a landmark trial, the first controlled clinical trial ever to compare full oral therapy with whole intravenous treatment cUTI, and the data support the value of tebipenem HBr as an oral outpatient therapy for cUTI.
given the high level of resistance to oral therapies currently available, tebipenem HBr would be the first oral cUTI drug in 26 years if approved by the FDA.
As an oral treatment that facilitates the use of medicines, tebipenem HBr avoids hospitalization, while shifting patients from intravenous injections to oral help to discharge and shorten hospital stays will further help save resources in the health care system.
source: Spero Therapeutics Announces Positive Topline Results from its Phase 3 ADAPT-PO Clinical Trial of Oral Tebipenem HBr in Complex Urinary Tract Tract Tract And Acute Pyelonephritis.