Pregnancy, Ectopic

LAUSANNE, Switzerland & BOSTON--( BUSINESS WIRE )-- Debiopharm ( www.debiopharm.com ), a Swiss-based global biopharmaceutical company, is proud to announce the extension of funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator ( CARB-X ), a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. This funding will support the preclinical development of Debio 1453, a novel antibiotic specifically designed to combat Neisseria gonorrhoeae infections . In line with the Debiopharm’s vision to set a new standard for treating N. gonorrhoeae infections by developing antibiotics with targeted activity, while potentially avoiding microbiome dysbiosis, the newly awarded $5.76 million USD will facilitate the advancement of essential preclinical research, positioning Debio 1453 for clinical progression. With Debio 1453, Debiopharm aims to provide a potentially valuable addition to the current antibiotic armamentarium, as a new treatment for N. gonorrhoeae infections, especially strains showing significant resistance to existing therapies. The project includes pivotal objectives such as the completion of non-clinical pharmacology and safety packages, the manufacturing of the active pharmaceutical ingredient (API) and drug product, and the submission for a first-in-human clinical trial. “The threat of antimicrobial resistant infections, like gonorrhea, is not slowing down. That’s why we’re taking action now to make suitable options available for patients in the future,” explained Thierry Mauvernay, President of Debiopharm. “This funding from CARB-X is vital, not only financially, but also to support and raise interest in the advancement of new antibiotic classes. This inspires our continued quest to reach important research milestones for this novel antibacterial designed to specifically treat gonorrhea infections that are resistant to current therapies.” “We are pleased to provide continued support for the preclinical development of Debio 1453,” said Erin Duffy, PhD, R&D Chief of CARB-X. “Neisseria gonorrhoeae has become resistant to every antibiotic class - and nearly all drugs in these classes - resulting in a growing and significant global public-health risk. With a novel way to target the bacteria and novel chemistry with which to do so, the Debiopharm product has the potential to be a significant new therapy for treating gonorrhea.” N. gonorrhoeae has emerged as a significant public health threat due to its rapidly increasing resistance to available antibiotic treatments. In 2020, there were approximately 82.4 million new cases of gonorrhea among individuals aged 15–49 years globally, 677,769 of which in the United States [1-2]. This issue underscores an urgent global need for new therapies to prevent complications like pelvic inflammatory disease, ectopic pregnancy, infertility, and even an elevated risk of contracting and spreading Chlamydia trachomatis and HIV infections, which can occur if gonorrhea infections are left untreated [1,3]. Gonorrhea can be passed from a pregnant mother to baby, for whom it can cause sepsis and neonatal conjunctivitis, which if left untreated may lead to complete blindness [3]. “We are running out of time when it comes to drug-resistant Neisseria gonorrhoeae . Today, these bacteria have managed to outsmart almost all current antibacterial therapies, soon leaving physicians unarmed to support their patients in the fight against this persistent superbug. Now more than ever, new antibiotics are needed to avoid serious public health consequences caused by this infection. CARB-X’s grant for Debio 1453 research, will fuel the advancement of this potential new option for patients,” expressed Morgane Vanbiervliet, Manager, Market intelligence, Infectious Diseases, Debiopharm. Debio 1453 leverages a unique mechanism of action that targets the FabI enzyme, which is critical for the growth and survival of N. gonorrhoeae . Studies presented at the 2024 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) have shown encouraging pre-clinical efficacy signals, highlighting Debio 1453’s potential to offer a powerful new weapon in the fight against resistant strains of N. gonorrhoeae . CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views CARB-X or its funders. About CARB-X CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list , or the Priority Bacterial Pathogens list published by the WHO , with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | X (formerly Twitter) @CARB_X Debiopharm's commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews Sources [1] WHO. “Multi-drug resistant gonorrhoea”. 2024 [2] CDC. “CDC’s 2022 STI Surveillance Report underscores that STIs must be a public health priority”. 2024 [3] WHO. “Gonorrhoea (Neisseria gonorrhoeae infection)”. 2024

THURSDAY, Nov. 7, 2024 -- Abortion pills are safe and effective even very early in a pregnancy, a new study finds. Clinics and hospitals tend to defer medication abortions until a woman’s pregnancy is confirmed using ultrasound, researchers said. But abortion pills can be safely taken prior to the sixth week of pregnancy, researchers reported Nov. 6 in the New England Journal of Medicine . “Women often find out very early if they’re pregnant, and a majority also know if they want a termination and if so, want it to take place as quickly as possible,” said lead researcher author Dr. Karin Brandell , a gynecologist at Karolinska University Hospital in Sweden. Doctors prefer delaying a medication abortion until an ultrasound is performed, to rule out the risk of an ectopic pregnancy, researchers said. Ultrasound reveals a pregnancy in weeks five to six. In an ectopic pregnancy, the embryo attaches outside the uterus, usually in the fallopian tubes, researchers said. An ectopic pregnancy is not terminated by a medication abortion, and can be life-threatening for the woman. For the study, researchers analyzed data on more than 1,500 women at 26 clinics in nine countries who requested an abortion before ultrasound was able to confirm their pregnancy. These women were randomly assigned to either receive their early medication abortion as requested or have their abortion delayed until pregnancy could be confirmed by ultrasound. In both groups, more than 95% of women had a complete and successful abortion. In the delayed treatment group, 4.5% of medication abortions failed and required additional surgery. In the early group, 3% of pregnancies continued and 1.8% of women required surgery for an incomplete abortion. Overall, 1% of all participants had an ectopic pregnancy, researchers found. “Very early medical abortion was just as effective and safe to perform, even in case of an undiagnosed ectopic pregnancy,” said Dr. Kristina Gemzell-Danielsson , a professor of obstetrics and gynecology at Karolinska Institute. Women in the early group reported less pain and bleeding. In both groups, women wanted to have their abortion performed as quickly as possible. “Abortion is a political as well as a medical issue,” Brandell said. “In Sweden, a woman can repeat the procedure a week after a failed early abortion. But a woman in Texas, where abortion is banned after the sixth week, can’t,” Brandell said. “It was therefore important to show that early abortion is equivalent to current standard procedure at a later stage of pregnancy.” Researchers now want to test if a new combination of drugs for early abortion might also prove effective in treating ectopic pregnancies. They are also developing new contraceptives based on mifepristone , one of the two drugs used in a medication abortion. “It can be taken in a lower dose than for abortion to prevent unwanted pregnancies in the form of one tablet a week, or when needed,” Gemzell-Danielsson said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

WEDNESDAY, Nov. 6, 2024 -- For complete abortion , medication abortion before confirmed intrauterine pregnancy is noninferior to standard, delayed treatment, according to a study published in the Nov. 7 issue of the New England Journal of Medicine . Karin Brandell, M.D., from the Karolinska Institutet in Stockholm, and colleagues conducted a multicenter, noninferiority, randomized controlled trial involving women requesting medication abortion at up to 42 days of gestation with an unconfirmed intrauterine pregnancy on ultrasound examination. Participants were randomly assigned to immediate start of abortion (early-start group; 754 participants) or standard-care treatment delayed until intrauterine pregnancy was confirmed (standard-care group; 750 participants). For the absolute between-group difference, the noninferiority margin was set at 3.0 percentage points. The researchers found that a complete abortion occurred in 95.2 and 95.3 percent of participants in the early-start and standard groups, respectively (absolute between-group difference, −0.1 percentage points). Ectopic pregnancies occurred in 1.3 and 0.8 percent of participants in the early-start and standard-care groups, respectively. Serious adverse events occurred in 1.6 and 0.7 percent of participants in the early-start and standard groups, respectively, most of which were uncomplicated hospitalizations for ectopic pregnancy or incomplete abortion. "We found that early start of medication abortion before confirmed intrauterine pregnancy was noninferior to delayed treatment after confirmed intrauterine pregnancy with respect to completing abortion," the authors write.