On 7 & 8th July 2017, leaders of the G20 met in Hamburg, Germany, to address major global economic challenges and to contribute to prosperity and well-being. Their Declaration, published on July 8, carries an important section on combatting antimicrobial resistance (AMR):
“AMR represents a growing threat to public health and economic growth. To tackle the spread of AMR in humans, animals and the environment, we aim to have implementation of our National Action Plans, based on a One-Health approach, well under way by the end of 2018.
We will promote the prudent use of antibiotics in all sectors and strive to restrict their use in veterinary medicine to therapeutic uses alone. Responsible and prudent use of antibiotics in food producing animals does not include the use for growth promotion in the absence of risk analysis. We underline that treatments should be available through prescription or the veterinary equivalent only. We will strengthen public awareness, infection prevention and control and improve the understanding of the issue of antimicrobials in the environment.
We will promote access to affordable and quality antimicrobials, vaccines and diagnostics, including through efforts to preserve existing therapeutic options. We highlight the importance of fostering R&D, in particular for priority pathogens as identified by the WHO and tuberculosis.
We call for a new international R&D Collaboration Hub to maximise the impact of existing and new anti-microbial basic and clinical research initiatives as well as product development. We invite all interested countries and partners to join this new initiative. Concurrently, in collaboration with relevant experts including from the OECD and the WHO, we will further examine practical market incentive options.”
Read the full news report from Nature Microbiology here.
The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency, and the United States’ Food and Drug Administration have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
Representatives from the three regulatory agencies met in Vienna on 26-27 April 2017 and discussed recommendations for the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. They identified a number of areas where the data requirements in the three regions could be streamlined. The three regulatory agencies will be working to update their guidance documents respectively.
Read the full press release here.
On Thursday, June 22nd from 8:30 to 9:30 EST (14:30-15:30 CEST, SAST), Dr. Yongge Liu, Director of Diagnostics at Otsuka Novel Products, gave a presentation on LAM (Lipoarabinomannan) as a Pharmacodynamic Biomarker and Drug Development Tool for TB.
Otsuka Pharmaceutical is developing an assay that can measure the concentration of LAM, which is showing promise as a biomarker of the load of viable tubercle bacilli in sputum. The assay shows potential for real-time evaluation of treatment response in clinical trials, and Otsuka is working with the Critical Path to TB Drug Regimens (CPTR) to seek qualification of this biomarker as a drug development tool by the FDA in the USA and as a drug development method by the EMA in the European Union. Yongge Liu, the Director of Diagnostics at Otsuka Novel Products, will discuss the development of this assay and the biomarker qualification process.
A copy of the presentation slides can be viewed here.
New research suggests the bacteria that cause tuberculosis alter their metabolism to combat exposure to antimicrobials, and that these metabolic “escape pathways” might be neutralized by new drugs to shorten the troublesome duration of therapy. Researchers studied the proteomic responses of the bacteria to five compounds – isoniazid, rifampicin, moxifloxacin, mefloquine and bedaquiline – and discovered escape pathways and enzymes associated with changes in metabolic state.
“When we looked at the enzymes carefully, we realized the enzymes being synthesized by the bacteria were enzymes connecting several different metabolic pathways,”Oregon State University scientist Luiz Bermudez said. “Then we came up with the idea that maybe what the bacteria were trying to do, in the presence of a bactericidal compound that was threatening their way of living, was use other ways to survive. One of the things we saw, for example, was a shift to an anaerobic metabolism, which makes a lot of drugs inactive and incapable of killing bacteria. “The gene inactivation of some of these enzymes results in improved drug efficacy against Mtb,” he said. “The identified proteins may provide powerful targets for development of synergistic drugs aimed to accelerate bacterial killing.”
Read the full statement here.
In a Personal View published in The Lancet Infectious Diseases, Amber Kunkel, Jennifer Furin and Ted Cohen argue that resistance concerns should not forestall use of bedaquiline in patients with XDR-TB. Their position in favour of increased access to bedaquiline for these patients is based on three arguments. First, the use of drug combinations that include bedaquiline might prevent spread of XDR disease to others in the community. Second, until new combination regimens of novel drugs for XDR-TB become available, patients with XDR disease and their infected contacts will face equivalent outcomes if bedaquiline is either not provided because of policy, or not effective because of resistance. Finally, because resistance to bedaquiline and other antituberculosis drugs is caused by mutations within a single bacterial chromosome, use of bedaquiline in patients with XDR-TB will not substantially increase the risk of bedaquiline resistance in patients with drug-susceptible or multidrug-resistant (non‑XDR) tuberculosis strains.
Read the full Personal View here.
Leaders from the governments of France and the Netherlands today urged funding for new treatment and prevention tools against drug-resistant tuberculosis at a high-level meeting in Brussels, citing the scope of the problem in Europe.
“Because of drug resistance, TB is evolving to become an untreatable disease for a growing number of people,” said Michèle Boccoz, Special Ambassador for fighting against HIV/AIDS and communicable diseases at the French Ministry of Foreign Affairs and International Development. “Investment in research and development now will allow us to have the drugs and vaccines at hand to eventually end the threat of TB as a health problem in Europe.”
“Without tools such as new drugs and vaccines, we know we cannot reach our goals for controlling TB,” said Marja Esveld, senior policy advisor, global health from the Dutch Ministry of Health. “Now is the time to step up the resources to ensure we have the means to effectively end the epidemic and address the emerging threat of drug-resistant TB.”
Read the article here.
DR-TB STAT and the Sentinel Project will host a webinar, MDR-TB Treatment with Bedaquiline in Children and Adolescents: Global Recommendations and Program Experience in Belarus on 26 May 2017 from 10-11am EDT.
Co-sponsored by DR-TB STAT and the Sentinel Project, this webinar will begin with an update on global guidelines for the use of new and re-purposed TB drugs by commentator Dr. Jennifer Furin. Subsequently, Dr. Skrahina will focus on interim results of bedaquiline use in the treatment of children and adolescents with multi-drug resistant tuberculosis in Belarus, including the acceptability of bedaquiline-containing regimens, culture conversion results, and the occurrence of adverse events. Dr. Skrahina and Dr. Furin will be joined by Dr. James Seddon as moderator.
For more information about the webinar and how to connect, click here.
Mark your calendar for Thursday, May 4th from 08:30 to 09:30 EST (14:30-15:30 CEST, SAST) for a presentation by Dr. Bern-Thomas Nyang’wa, MD, on the TB-PRACTECAL trial.
The Pragmatic Clinical Trial for More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s) (TB-PRACTECAL) is a multi-center, open label, multi-arm, randomized, controlled phase II-III trial. TB-PRACTECAL, a Médecins Sans Frontières (MSF) sponsored clinical trial, aims to evaluate short treatment regimens that contain bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary MDR- and XDR-TB. The trial’s first patient was randomized and started treatment on January 17, 2017. Additional information on the trial can be found at https://www.msf.org.uk/content/tb-practecal.
Presentation slides will be made available shortly.
On World Tuberculosis Day, TB Alliance and the Medicines Patent Pool (MPP) announced a licensing agreement for the clinical development of sutezolid, an antibiotic drug candidate which demonstrated encouraging results in early studies. The sublicense pertains to the development of sutezolid in combination with other TB drugs and follows the MPP’s license for the treatment signed with patent holder The Johns Hopkins University in January.
Sutezolid is in the same class of drugs as linezolid (oxazolidinones), which is used in some countries as a treatment option for drug-resistant TB (DR-TB). Tests conducted over the past decade have indicated that sutezolid may have a better therapeutic potential than linezolid.
“We are grateful to the civil society coalition that pushed for the clinical development of sutezolid. If further studies are successful, this product could be a game-changer in improving options for patients” said Greg Perry, Executive Director of the Medicines Patent Pool.
To read the full article, click here.
New Delhi, Apr 11: The Centre has decided to expand the availability of Bedaquiline, a drug used for treatment of drug-resistant tuberculosis, across the country.
Union Health Minister J P Nadda said that under the revised National TB Control Programme (RNTCP) in India, the drug is currently available in five cities – Ahmedabad, Delhi, Chennai, Mumbai and Guwahati.
“Based on the limited use of the drug in these five states and cities, it has been decided to expand the availability in rest of the country. Country-wide training is being carried out to build capacity of other states, and the states are also being prepared to monitor the treatment of patients with Bedaquiline containing regimen,” Nadda said.
Read the full article here.