Breaking News
December 15, 2018 - Cancer Research UK and AstraZeneca open new Functional Genomics Centre
December 15, 2018 - New research lays out potential path for treatment of Huntington’s disease
December 15, 2018 - Prestigious R&D 100 Award presented to Leica Microsystems
December 15, 2018 - Study shows septin proteins detect and kill gut pathogen, Shigella
December 15, 2018 - Study sheds new light on disease-spreading mosquitoes
December 15, 2018 - 2017 Saw Slowing in National Health Care Spending
December 15, 2018 - Monitoring movement reflects efficacy of mandibular splint
December 15, 2018 - Study supports BMI as useful tool for assessing obesity and health
December 15, 2018 - Self-guided, internet-based therapy platforms effectively reduce depression
December 15, 2018 - Organically farmed food has bigger climate impact than conventional food production
December 15, 2018 - Faster, cheaper test has potential to enhance prostate cancer evaluation
December 15, 2018 - Researchers study abnormal blood glucose levels of patients after hospital discharge
December 15, 2018 - Swedish scientists explore direct association of dementia and ischemic stroke deaths
December 15, 2018 - Study finds 117% increase in number of dementia sufferers in 26 years
December 15, 2018 - Eczema Can Drive People to Thoughts of Suicide: Study
December 15, 2018 - Link between neonatal vitamin D deficiency and schizophrenia confirmed
December 15, 2018 - Nurse denied life insurance because she carries naloxone
December 15, 2018 - Ritalin drug affects organization of pathways that build brain networks used in attention, learning
December 15, 2018 - Research pinpoints two proteins involved in creation of stem cells
December 15, 2018 - Gut bacteria may modify effectiveness of anti-diabetes drugs
December 15, 2018 - How often pregnant women follow food avoidance strategy to prevent allergy in offspring?
December 15, 2018 - Using machine learning to predict risk of developing life-threatening infections
December 15, 2018 - How imaginary friends could boost children’s development
December 15, 2018 - Folate deficiency creates more damaging chromosomal abnormalities than previously known
December 15, 2018 - Study provides new insights into molecular mechanisms underlying role of amyloid in Alzheimer’s disease
December 15, 2018 - For the asking, a check is in the mail to help pay for costly drugs
December 15, 2018 - UA scientists uncover biological processes leading to rare brain disorder in babies
December 15, 2018 - The largest database on industrial poisons
December 15, 2018 - ESMO Immuno-Oncology Congress showcases novel technologies set to benefit many cancer patients
December 15, 2018 - Ovid Therapeutics Announces Plans to Move into a Phase 3 Trial in Pediatric Patients Based on End-of-Phase 2 Meeting for OV101 in Angelman Syndrome
December 15, 2018 - Left ventricular noncompaction – Genetics Home Reference
December 15, 2018 - Children’s sleep not significantly affected by screen time, new study finds
December 15, 2018 - When should dementia patients stop driving? A new guidance for clinicians
December 15, 2018 - Researchers use INTEGRA’s VIAFLO 96/384 to streamline the experimental workflow
December 15, 2018 - Researchers discover protein involved in nematode stress response
December 15, 2018 - Cancer patients have greater risk of developing shingles, study shows
December 14, 2018 - UAlberta scientists identify biomarkers for detecting Alzheimer’s disease in saliva samples
December 14, 2018 - Study uncovers link between tube travel and spread of flu-like illnesses
December 14, 2018 - Caffeine plus another compound in coffee may fight Parkinson’s disease
December 14, 2018 - GW researchers review studies on treatments for prurigo nodularis
December 14, 2018 - Lack of peds preventive care ups unplanned hospital admissions
December 14, 2018 - Miscarriage: When Language Deepens Pain
December 14, 2018 - New method helps better understand pathological development of ALS
December 14, 2018 - Intellectually active lifestyle confers protection against neurodegeneration in Huntington’s patients
December 14, 2018 - Mammalian collagen nanofibrils become stronger and tougher with exercise
December 14, 2018 - Considerable Morbidity, Mortality Due to Animal Encounters
December 14, 2018 - Researchers find inhibiting one protein destroys toxic clumps seen in Parkinson’s disease
December 14, 2018 - How early physical therapy can lessen the long-term need for opioids
December 14, 2018 - Depression, suicide rates highest in Mountain West states
December 14, 2018 - New model could cure the potential to underestimate how quickly diseases spread
December 14, 2018 - Exercise-induced hormone activates cells critical for bone remodeling in mice
December 14, 2018 - Researchers discover new mechanism behind spread of malignant pleural mesothelioma
December 14, 2018 - Health Tip: Celebrate a Healthier Holiday
December 14, 2018 - Scalpel-free surgery enhances quality of life for Parkinson’s patients, study finds
December 14, 2018 - Early physical therapy can reduce risk, amount of long-term opioid use | News Center
December 14, 2018 - Genetic marker, predictor of early relapse in common childhood cancer discovered
December 14, 2018 - Study could lead to a potential new way of treating sepsis
December 14, 2018 - New protein complex helps embryonic stem cells to maintain their indefinite potential
December 14, 2018 - Salk professor receives $1.8 million from NOMIS Foundation for research on mechanisms to promote health
December 14, 2018 - New discovery will improve the safety and predictability of CRISPR
December 14, 2018 - Geneticists discover how sex-linked disorders arise
December 14, 2018 - New method to visualize small-molecule interactions inside cells
December 14, 2018 - Study describes mechanism that makes people more vulnerable to hunger-causing stimuli
December 14, 2018 - Chronic opioid therapy associated with increased healthcare spending and hospital stays
December 14, 2018 - Blood Types
December 14, 2018 - Obesity linked to increased risk of early-onset colorectal cancer
December 14, 2018 - Blood test helps identify distinct molecular signatures in children with cystic fibrosis
December 14, 2018 - In California, doctors accused of sexual misconduct often get second chances
December 14, 2018 - Scientists use water to track electrical activity of nerve cells
December 14, 2018 - Recurrence of urinary tract infection may depend on bacterial strain, study shows
December 14, 2018 - GBT Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for the Treatment of Sickle Cell Disease and GBT Plans to Submit New Drug Application (NDA)
December 14, 2018 - Partial Thromboplastin Time (PTT) Test: MedlinePlus Lab Test Information
December 14, 2018 - Common tactics for health promotion at work may be detrimental to employees with obesity
December 14, 2018 - Myths about migration and health not supported by available evidence
December 14, 2018 - Recent findings on rare genetic disorder may help develop new treatment options
December 14, 2018 - New drug shows promise in treating sarcomas
December 14, 2018 - Scientists perform lung lavage as new approach for tuberculosis diagnosis in rhinoceros
December 14, 2018 - Answering the Biggest Neurological Research Questions of Today
December 14, 2018 - Recent winners of the Nobel Medicine Prize
December 14, 2018 - KHN’s ‘What the Health?’ Insurance enrollment is lagging — and there are lots of reasons why
Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine

Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine

image_pdfDownload PDFimage_print

WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) — Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin represents a new type of oral antibiotic that inhibits DNA synthesis in a manner different from currently approved classes of antibiotic drugs. The clinical trial was sponsored by The National Institute of Allergy and Infectious Disease (NIAID), part of the U.S. National Institutes of Health (NIH).

Gonorrhea is a common sexually transmitted disease (STD) that affects both men and women, particularly young people ages 15 to 24 years. Gonorrhea is the second most commonly reported notifiable disease in the United States. In 2017, more than 550,000 cases of gonorrhea were reported in the United States. If untreated, gonorrhea infection can lead to pelvic inflammatory disease, ectopic pregnancy, infertility, and an increased risk of HIV infection. Pregnant women can pass the infection to their babies, who can become blind or develop life-threatening infections as a result.

Gonorrhea is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to each of the antimicrobials used to treat it. As a result, in 2015, the U.S. Centers for Disease Control and Prevention revised gonorrhea treatment guidelines to recommend dual therapy with injectable ceftriaxone and oral azithromycin to reduce the emergence of resistance to ceftriaxone.

“The rate of reported gonorrhea cases in the United States has increased 75 percent since the historic low in 2009, and antibiotic resistance has considerably reduced the number of treatment options for this disease,” said NIAID Director Anthony S. Fauci, M.D. “These research findings published today suggest that zoliflodacin has the potential to be a useful and easy-to-administer oral antibiotic for treating gonorrhea.”

The study took place from November 2014 through December 2015 and was a multi-center, randomized, open-label study that enrolled 179 participants (167 men, and 12 non-pregnant women) between the ages of 18 to 55 with either symptoms of uncomplicated urogenital gonorrhea, untreated urogenital gonorrhea or sexual contact with someone with gonorrhea within 14 days before enrollment. Participants were randomly selected to receive either a single 2- or 3-gram dose of oral zoliflodacin or a 500 milligram (mg) dose of injectable ceftriaxone. Among the 117 per-protocol participants who were evaluated six days after treatment, 98 percent (48 of 49 participants) of those who received the 2-gram zoliflodacin dose, 100 percent (47 of 47 participants) of those who received the 3-gram dose, and all (21 of 21) of the participants in the ceftriaxone group were considered cured of their urogenital gonorrhea based on culture results.

Zoliflodacin cured all rectal gonorrheal infections (5 of 5 participants who received the 2-gram dose; 7 of 7 participants who received the 3-gram dose) as did ceftriaxone (3 of 3 participants). In treating patients with gonorrhea infections of the throat (pharyngeal), 50 percent of volunteers who received the 2-gram dose (4 of 8 participants) and 82 percent of those who received the 3-gram dose (9 of 11 participants) were cured. All of the participants (4 of 4) in the ceftriaxone group achieved a cure. Zoliflodacin was generally well-tolerated with transient gastrointestinal upset the most commonly reported adverse effect. Microbiological evaluation of post-treatment clinical isolates did not show any resistance to zoliflodacin.

“We are grateful for the work done by the NIAID and pleased to have data on zoliflodacin published in the New England Journal of Medicine,” stated Manos Perros, President and Chief Executive Officer of Entasis Therapeutics. “The results highlighted in the NEJM’s publication provide support for the therapeutic potential of zoliflodacin in gonococcal infections and we look forward to advancing our Phase 3 clinical trial.”

Zoliflodacin has received Fast Track designation and qualified infectious disease product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for development solely as oral treatment for gonococcal infections. Entasis, in partnership with GARDP, will begin Phase 3 testing of zoliflodacin in the Netherlands, South Africa, Thailand and the United States next year.

About Zoliflodacin

Zoliflodacin is a novel oral antibiotic for the treatment of uncomplicated gonorrhea and the first of a novel class of molecules to be developed for this indication. Uncomplicated gonorrhea is becoming increasingly difficult to treat as the Neisseria gonorrhoeae bacterium has developed resistance to successive classes of antibiotics. There are currently few oral treatment options, and the Centers for Disease Control and Prevention (CDC) has designated N. gonorrhoeae an urgent public health threat that requires aggressive action. N. gonorrhoeae has developed resistance to all classes of antimicrobials previously recommended for treatment of uncomplicated gonorrhea. As a result, the CDC treatment guidelines require dual therapy with injectable ceftriaxone and oral azithromycin.

Uncomplicated gonorrhea infections carry high morbidity, enhance transmission of other sexually transmitted diseases and are highly stigmatized. Published studies have demonstrated the potent in vitro activity of zoliflodacin against N. gonorrhoeae, including isolates resistant to fluoroquinolones and extended spectrum cephalosporins. Zoliflodacin received Fast Track designation and qualified infectious disease product (QIDP) designation by the U.S. Food and Drug Administration (FDA).

About Entasis

Entasis Therapeutics is developing a portfolio of innovative product candidates to treat serious Gram-negative multi-drug resistant bacterial infections. Entasis’ anti-infective discovery platform has produced a pipeline of meaningfully differentiated programs which target serious bacterial infections, including ETX2514SUL (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae), ETX0282CPDP (targeting Enterobacteriaceae infections), and non-Beta-lactam PBP inhibitors or NBPs (targeting Gram-negative infections). www.entasistx.com

About the National Institutes of Health (NIH)

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

About The National Institute of Allergy and Infectious Diseases (NIAID)

The NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About GARDP

GARDP is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new or improved antibiotic treatments, while endeavoring to ensure their sustainable access. Initiated by the World Health Organization (WHO) and the Drugs for Neglected Disease initiative (DNDi), GARDP is an important element of WHO’s Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships to encourage research and development of new antimicrobial agents and diagnostics. GARDP is currently hosted by DNDi. www.gardp.org

Forward-Looking Statements

This press release includes certain disclosures which contain “forward-looking statements,” including, without limitation, statements regarding potential attributes and benefits of zoliflodacin and Entasis’ expectations regarding a planned Phase 3 trial. Forward-looking statements are based on Entasis’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, unexpected safety or efficacy data observed during preclinical or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of the Company’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Many of these factors are beyond Entasis’ control. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to Entasis’ initial public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Source: Entasis Therapeutics

Posted: November 2018

About author

Related Articles