Listing a study does not mean it has been evaluated by the U.S. Federal Government. Of the 141 evaluable participants, a microbiologic cure at urogenital sites was observed 55/57 (96.5%) of those in the 2 g zoliflodacin group, 54/56 (96.4%) in the 3 g zoliflodacin group, and 28/28 (100%) who received ceftriaxone. Zoliflodacin Was Well-Tolerated and Successfully Treated Substantially All Uncomplicated Gonorrhea Cases. Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin). Previous randomisation in this clinical trial. This single pivotal trial is a multi-center, open-label, randomized, controlled, non-inferiority, phase 3 trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin, compared to a single intra-muscular dose of 500 mg ceftriaxone combined with a single oral dose of 1 g azithromycin, which is standard of care for the treatment of uncomplicated Neisseria gonorrhoeae (NG) infection. You can be assured our editors closely monitor every feedback sent and will take appropriate actions. Under the partnership agreement, GARDP is responsible for the phase 3 trial and pharmaceutical development activities for zoliflodacin to support regulatory approval and market access and availability. At the same time, we are observing increasing resistance to the last line-options for treatment in Neisseria gonorrhoeae. The phase 3 trial initiation marks an important milestone for this novel industry and non-profit partnership in jointly developing a novel antibiotic and building a strategic plan for successful market access within the countries that have high rates of gonorrhoea and for patients who need it most. [ Time Frame: Day 6 ], Microbiological cure rate of Neisseria gonorrhoeae (NG) at urogenital sites will be determined. Phase 3 clinical trial, in partnership with GARDP, to begin in 2019 It is expected to begin Phase 3 testing in the Netherlands, South Africa, Thailand and the United States next year. You have reached the maximum number of saved studies (100). Data from the phase 3 clinical trial is anticipated in 2021. This was the second of three clinical trials needed for U.S. approval of zoliflodacin. Gonorrhoea is a common sexually transmitted infection (STI) affecting both men and women, particularly between 15 and 24 years old. and Terms of Use. Entasis’ partnership with GARDP reflects our commitment to enable global access of this potential novel oral treatment for a disease that is quickly becoming resistant to all currently available antibiotics,” said Manos Perros, PhD, President and Chief Executive Officer of Entasis Therapeutics. Microbiological cure as determined by culture at urethral or cervical sites at test of cure visit. "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. We do not guarantee individual replies due to extremely high volume of correspondence. Our partnership with Entasis is critical for preventing the dire scenario of untreatable gonorrhea and controlling this infection,” said Dr. … [ Time Frame: Day 6 ], Microbiological cure rate of urogenital gonorrhoea will be determined among women and men respectively, after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. Entasis has a second program, gyrase-inhibitor zoliflodacin, that is also set to enter phase 3 next year. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959527. Zoliflodacin (development codes AZD0914 and ETX0914) is an experimental antibiotic that is being studied for the treatment of infection with Neisseria gonorrhoeae . Please remove one or more studies before adding more. In the partnership, Entasis retains all commercial rights to zoliflodacin in high-income territories while GARDP receives commercial rights in low- and some middle-income countries. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. [2] Patients included in the trial will be randomized (2:1) to receive either zoliflodacin or a combination of ceftriaxone and azithromycin and will be assessed one week later for persistence of the infection. Three sites across two provinces in South Africa are set to take part in the study. Your feedback will go directly to Science X editors. However, the presence of extraurogenital infections will also be studied as a secondary end point in the hope that this data will … "We both believe a solution lies with an oral treatment option, which not only overcomes existing resistance but also offers significant benefits compared to the current standard of care of one or more intramuscular injections. Our data support the initiation of the global zoliflodacin phase 3 randomized controlled clinical trial for uncomplicated gonorrhea. Entasis' partnership with GARDP reflects our commitment to enable global access of this potential novel oral treatment for a disease that is quickly becoming resistant to all currently available antibiotics," said Manos Perros, Ph.D., President and Chief Executive Officer of Entasis Therapeutics. This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea. The content is provided for information purposes only. Provided by This is an open-label trial comparing a single 3 g oral dose of zoliflodacin to a combination of ceftriaxone and azithromycin (2:1 randomization). The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. This document is subject to copyright. 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. Global Antibiotic Research & Development Partnership. Phase 3 trials will start next year, Taylor said. „Die phase-3-Studie von zoliflodacin markiert die Letzte große klinische Studie für unser Gonorrhoe Programm. You can unsubscribe at any time and we'll never share your details to third parties. 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 … "The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. "The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. Apart from any fair dealing for the purpose of private study or research, no Phase 3 trials will start next year, Taylor said. The trial is expected to enrol approximately 1,000 adults with urogenital gonorrhoea from clinical trial sites in the United States, Netherlands, Thailand and South Africa. The trial was designed to evaluate the safety of zoliflodacin and to inform the decision to proceed to a phase 3 trial. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Efficacy of a single dose of zoliflodacin will be assessed compared to a combination of a single dose of ceftriaxone and azithromycin. “The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. Proportion of participants with a negative NG NAAT from urethral or cervical, oropharyngeal and rectal sites at test of cure visit. All rectal infections were cured in participants who received 2 or 3 g zoliflodacin and ceftriaxone. Biopharmaceutical company Entasis Therapeutics and the nonprofit Global Antibiotic Research and Development Partnership (GARDP) today announced the initiation of a global phase 3 clinical trial for zoliflodacin, a new antibiotic for treating uncomplicated gonorrhea. [ Time Frame: Day 2 ], Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and thics guidance), Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture), For females of child-bearing potential, a negative urine pregnancy test at screening. Participant in this arm will receive a single dose of zoliflodacin. "The initiation of the phase 3 trial of zoliflodacin is an important milestone and brings hope for people affected by this disease. Click here to sign in with [ Time Frame: Day 6 ], Microbiological cure rate of rectal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. [ Time Frame: Day 6 ], The eradication rate of NG nucleic acid will be determined from urogenital rectal, pharyngeal specimens after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. The Global Antibiotic Research and Development Partnership (GARDP), a not for profit organisation developing new treatments for drug resistant infections, and Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today jointly announced the initiation of a global phase 3 pivotal trial of zoliflodacin. Phase 3 clinical development program of zoliflodacin •Phase 2 study has completed enrollment •Licensure in the US and in the EU will require a single Phase 3 study –Approximately 600 patients –Approximately 18-24 months from first patient enrolled to final … Talk with your doctor and family members or friends about deciding to join a study. It has a novel mechanism of action which involves inhibition of bacterial type II topoisomerases . [ Time Frame: Day 6 and Day 30 ], Microbiological cure rate of pharyngeal gonorrhoea will be determined after administration of a single dose of zoliflodacin compared to a combination of a single dose of ceftriaxone and azithromycin. This was the second of three clinical trials needed for U.S. approval of zoliflodacin. Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at the test of cure visit and for whom the baseline antimicrobial susceptibility profile indicated pre-existing resistance to antibiotics commonly used for Neisseria gonorrhoeae (NG) treatment. Information provided by (Responsible Party): This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. In July 2017, Entasis partnered with the Global Antibiotic Research and Development Partnership (GARDP) to co-develop zoliflodacin through Phase 3. Zoliflodacin is a novel, first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhoea. "The phase 3 trial of zoliflodacin marks the last major clinical trial for our gonorrhoea program. The compound, which has been granted qualified infectious disease product status and fast track designation by the U.S. Food and Drug Administration, has successfully completed both phase I ( 3) and phase 2 ( 4) clinical studies, and phase 3 testing will begin in 2019. Daily science news on research developments and the latest scientific innovations, The latest engineering, electronics and technology advances, The most comprehensive sci-tech news coverage on the web. We look forward to continuing our relationship with GARDP as we progress this global phase 3 trial.". The Drugs for Neglected Diseases initiative is … This QC range will be used for in vitro susceptibility testing of zoliflodacin during phase 3 human clinical trials and surveillance studies, and eventually it will be implemented in clinical labs. Data from the phase 3 clinical trial is anticipated in 2021. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Proportion of participants with microbiological cure as determined by culture at pharyngeal sites at test of cure visit. (Clinical Trial), Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin, A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea, Active Comparator: ceftriaxone and azithromycin combination, 12 Years and older (Child, Adult, Older Adult), Birmingham, Alabama, United States, 35294-0006, San Francisco Department Of Public Health City Clinic, San Francisco, California, United States, 94103, Indianapolis, Indiana, United States, 46202, Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States, 70112, Public Health - Seattle & King County STD Clinic, Seattle, Washington, United States, 98104, Public Health Service (GGD) Amsterdam / STI Outpatient Clinic, SAMRC Botha's Hill Clinical Research Site, Bangrak STI Center at Bangklo Branch Department of MTB, Bangrak STI Center at Rat Pracha Samasai Institute.
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