Do you know new antibiotics Proven to treat UTIs successfully? Gepotidacin, a possible new antibiotic for uncomplicated urinary tract infections (UTIs), has been so successful in treating patients that GSK has ended two phase 3 clinical studies for the medicine almost a year earlier than anticipated, the firm announced on November 3.
The first new class of oral antibiotics for treating uncomplicated urinary tract infections in more than 20 years would be the first-in-class triazaacenaphthylene antibiotic. Gepotidacin inhibits two essential enzymes necessary for bacterial reproduction.
The Independent Data Monitoring Committee (IDMC), according to the business, determined that gepotidacin met the combined primary effectiveness endpoint in both trials during a pre-specified interim examination of efficacy and safety data.
In the first half of 2023, GSK intends to submit a new drug application to the FDA in the United States.
New antibiotic therapies are required, according to Christopher Corsico, MD, MPH, senior vice president of development at GSK, as the frequency of STIs brought on by [resistant] bacteria rises. According to Dr. Corisco, GSK now has the chance to start the approval procedure to provide a new class of antibiotics to patients with UTIs as a result of the committee’s proposal to discontinue the EAGLE-2 and 3 studies early for effectiveness.
- 1 Gepotidacin Is the First New Novel Antibiotic for UTI in Over 20 Years
- 2 Gepotidacin Was Just as Effective as a Common First-Line Antibiotic in Clinical Trials
- 3 Antibiotic Resistance Could Undo Decades of Medical Progress
- 4 UTIs Are Increasingly Resistant to Major Antibiotics
- 5 New Antibiotic Will Likely Be Studied and Used to Treat More Serious Infections
Gepotidacin Is the First New Novel Antibiotic for UTI in Over 20 Years
According to Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore who was not involved in the development of the antibiotic, the excitement surrounding the trial results and the potential approval of gepotidacin stems from the fact that it is a new class of antibiotics. New types of antibiotics don’t appear all that frequently, he claims.
According to the business, gepotidacin was created as a consequence of a public-private cooperation between GSK and the US government, which supported the development of antibiotics to combat antibiotic resistance.
The goal of partnerships like this one is to promote the creation and ultimate approval of novel medicines. Dr. Adalja concurs, saying that it is encouraging to see a large pharmaceutical corporation like GSK working in the less lucrative field of antibiotics.
Gepotidacin Was Just as Effective as a Common First-Line Antibiotic in Clinical Trials
Researchers evaluated the safety and efficacy of gepotidacin with nitrofurantoin, one of the traditional first-line antibiotic therapies for UTIs, in two studies with more than 3,000 participants to see how well it treated the infections. Participants either got 100 mg of nitrofurantoin twice daily for five days or 1,500 mg of gepotidacin twice daily.
The combined clinical and microbiologic resolution (no indication of the infections in the lab) at the test-of-cure visit, which was around 28 days later, was the key efficacy endpoint. The trial’s primary effectiveness end goal was met, and no safety issues were found, according to GSK.
Antibiotic Resistance Could Undo Decades of Medical Progress
According to Adalja, antibiotic resistance “threatens to return a medicine to the pre-penicillin age; it makes all the everyday components of medicine more difficult and complicated, such as joint replacements, transplants, cancer treatments, and treatment of infections.”
Antibiotic-resistant bacteria and fungi cause more than 2.8 million illnesses and 35,000 fatalities in the United States annually, according to a 2019 study on antibiotic resistance concerns from the Centers for Disease Control and Prevention (CDC). This equates to a new case of an antibiotic-resistant infection every 11 seconds and a fatal infection-related illness every 15 minutes.
UTIs Are Increasingly Resistant to Major Antibiotics
UTIs, also known as bladder infections, are often brought on by bacteria that enter the urinary tract through the bladder. According to the U.S. Department of Health and Human Services, women are nearly 30 times more likely than males to have these infections, and more than half of women will experience at least one UTI in their lifetime.
Up to 4 in 10 women who get a UTI will experience at least one more in the next six months. Some women experience recurrent UTIs.
According to Stanford Medicine, UTIs are becoming increasingly and more resistant to common medications, which can make the infection more challenging to treat and cause consequences.
New Antibiotic Will Likely Be Studied and Used to Treat More Serious Infections
Adalja predicts that getting the antibiotic licensed for use in treating UTI will be the first step. “Given the variety of treatments available for treating urinary tract infections, I don’t anticipate a significant influence in that area. The medicine will start to be used off-label for more serious infections, and it will then be researched for those indications, he predicts.
Off-label usage of medicine is defined as use that is not authorized. In this instance, it indicates that illnesses other than UTIs will be treated with antibiotics.