STOP-TB Partnership KOREA X Othsuka-TB Projects 하기완

VOL.07 2021.08.12


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하기완

(STOP-TB협력위원,
Otsuka-TB Projects)

Kiwan.Ha@kr.otsuka.com

TB Clip 2021년 8월호 본문 이미지	ZeNix 연구결과에 따르면 BPaL regimen은 리네졸리드의 투여량 또는 투약기간의 감소에도 불구하고, 약물 내성이 높은 형태의 결핵에 대해 여전히 효과적이었습니다. TB Alliance가 주도한 이 시험의 목적은 BPaL 요법의 효능을 유지하면서 환자의 리네졸리드 노출 및 관련 부작용을 줄일 수 있는지 여부를 평가하는 것이었습니다. TB Alliance는 ZeNix의 최근 연구결과를 8월 12일(한국시간 오후 9시부터 11시)에 웨비나를 통해 공유할 예정이라고 하니, 웨비나에 등록하려면 여기를 클릭하십시오
TB Clip 2021년 8월호 본문 이미지	오츠카 제약의 항결핵신약 후보물질 "OPC-167832"와 MDR-TB치료제 'Delamanid" 그리고 얀센의 "Bedaquiline” 3제 병용으로 DS-pulmonary TB 환자를 대상으로 한 임상시험을 위해 BMGF에서 최대 USD17.8M의 보조금을 지원했습니다. 2022년에 시작하는 phase2 임상시험은 기존의 standard regimen 6개월요법과 3제 병용에 의한 신규 regimen의 4개월 요법의 안전성과 유효성을 평가하기 위함 입니다.
TB Clip 2021년 8월호 본문 이미지	유럽의약품청(European Medicines Agency)의 인체용 의약품위원회 (Committee for Medicinal Products for Human Use, CHMP)는 체중 10kg이상의 MDR-TB 소아환자에게 투여할 어린이 친화적인 25mg 분산성 Deltyba에 대해 positive opinion을 부여했습니다.

TB Clip 2021년 8월호 본문 이미지	레고켐바이오 '델파졸리드', MRSA 균혈증 대상 국내 임상2a상 승인 more +
TB Clip 2021년 8월호 본문 이미지	코로나 백신, 다른 백신과 동시 접종해도 될까? more +
TB Clip 2021년 8월호 본문 이미지	결핵균은 어떻게 인간의 면역 방어를 무너뜨리나 more +
TB Clip 2021년 8월호 본문 이미지	'감염병이 발병된 경우' 계약 해지…기간제 교사 계약서 논란 more +
TB Clip 2021년 8월호 본문 이미지	큐리언트,먹는 코로나 염증치료제 '텔라세벡' 임상 2상 환자투약 개시 more +
TB Clip 2021년 8월호 본문 이미지	고성에 ‘셔우드 홀 기념관’ 생긴다 more +
TB Clip 2021년 8월호 본문 이미지	獨 바이오엔테크, 말라리아ㆍ결핵 백신 개발 가속 more +
TB Clip 2021년 8월호 본문 이미지	라이트펀드, 감염병 신규 연구개발에 136억 추가 지원 more +
TB Clip 2021년 8월호 본문 이미지	건양의대, 국가결핵관리 정책 효과 첫 입증 more +
TB Clip 2021년 8월호 본문 이미지	"감염병, '예방'만이 종식가능…잠복결핵 치료 강조된 이유" more +

In an effort to foster and achieve universal access to TB diagnostics and inform research and development (R&D) priorities for TB diagnostic tools, the World Health Organization (WHO) has released an updated target product profile (TPP) for next-generation drug-susceptibility (DST) testing for M. tuberculosis at peripheral centres at peripheral centres.

The World Health Organization (WHO) published a Position statement on innovative clinical trial designs for development of new TB treatments aiming to support TB regimen development by highlighting key clinical trial characteristics to help advance novel therapies.

A WHO assessment of the benefit and risk profiles of four TB medicines: delamanid, bedaquiline, clofazimine and linezolid for their use in treatment of MDR-TB has confirmed the current safety profiles. Furthermore, no regulatory action (i.e. labelling change) is considered necessary at present. However, the assessment also points out some “potential signals of emerging risks” in relation to these medicines and recommends continued active monitoring. The investigation has been conducted by WHO's team on pharmacovigilance and the Global TB Programme in collaboration with the Special Programme for Research and Training in Tropical Diseases (TDR). Active TB Drug Safety Monitoring and Management (aDSM) global database.

WHO continues to publish updates to its consolidated guidelines on tuberculosis. The latest is Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update”.

WHO and the Global Fund have signed a cooperation and financing agreement to implement strategic initiatives to accelerate the end of AIDS, TB and malaria and protect hard-won gains from new pandemics like COVID-19. Initiatives include:

efforts to find people with TB missed by health systems in 20 countries;

the introduction of innovation for multi-drug resistant TB treatment through regional operational research in Eastern and Central Europe;

TB Clip 2021년 8월호 본문 이미지	The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted positive opinion in the European Union for Otsuka’s child-friendly 25 mg dispersible tablet formulation of Deltyba® (delamanid) for the paediatric population weighing at least 10 kg with pulmonary multidrug-resistant TB.
TB Clip 2021년 8월호 본문 이미지	“Otsuka is on course to further expand use of its treatment for pulmonary multidrug resistant tuberculosis (MDR-TB) to children”, reports Fierce Pharma. The news of the CHMP positive opinion for the paediatric dispersible formulation of Deltyba® (delamanid) was relayed globally by 34 syndicated newswires.
TB Clip 2021년 8월호 본문 이미지	On 12 August 2021, TB Alliance will host a public webinar for community stakeholders to share details of the recently announced results from the ZeNix Phase 3 clinical trial. The trial revealed that the 6-month BPaL treatment regimen (bedaquiline, pretomanid and linezolid) remains effective against highly drug-resistant strains of TB with either reduced dosage or duration of the linezolid component of the regimen. To register for the webinar, click here.
TB Clip 2021년 8월호 본문 이미지	The Stop TB Partnership’s Global Drug Facility (GDF) announced the inclusion in its catalog, for the first time ever, of two ultra-portable digital X-ray systems and two software packages for the computer-aided detection of TB based on artificial intelligence. To help facilitate uptake of these new technologies, the Stop TB Partnership launched a Practical guide on screening and triage for TB using computer-aided detection technology and ultra-portable X-ray systems.
TB Clip 2021년 8월호 본문 이미지	The Unite4TB project, whose partners include Otsuka, Janssen and GSK and leading academic institutions. has been officially launched. The project has received EUR 185 million from the EU and pharmaceutical companies to develop new and highly active tuberculosis treatment regimens for drug-resistant and -sensitive TB.
TB Clip 2021년 8월호 본문 이미지	TB Alliance launched a webpage to provide information on national-level access to the BPaL regimen - a three-drug, 6-month, all-oral regimen composed of bedaquiline, pretomanid and linezolid for the treatment of highly drug-resistant forms of TB. To explore the tool, click here.
TB Clip 2021년 8월호 본문 이미지	A new deep learning model rivaled radiologists’ accuracy at assessing TB on chest X-rays. The tool may prove particularly useful for triaging patients in low-resource settings. Source: Health Imaging
TB Clip 2021년 8월호 본문 이미지	The Indian health ministry said that coronavirus infection could make a person more susceptible to developing TB, but added that there was not enough scientific evidence to link the two. The health ministry recommended TB screening for all COVID-19 patients and coronavirus screening for all diagnosed TB patients.
TB Clip 2021년 8월호 본문 이미지	The Stop TB Partnership’s TB REACH announced approval of 11 new Wave 9 projects selected for funding to address inequities in drug-resistant TB in partnership with the United States Agency for International Development (USAID) Global Accelerator to End TB for a total of US$6.14 million.
TB Clip 2021년 8월호 본문 이미지	Researchers have got new insight into the molecular mechanism of the TB bacterium that helps it evade the human immune system. Source: Down To Earth
TB Clip 2021년 8월호 본문 이미지	A five-year health plan to reduce TB in England has been launched by the government. While the number of cases declined in 2020, COVID-19 has had an impact on diagnoses.

TB Clip 2021년 8월호 본문 이미지	The journal Nature reviews the Tuberculosis Drug Accelerator, a ten year experiment designed to facilitate collaboration in drug discovery by breaking down barriers among competing labs and institutions.
TB Clip 2021년 8월호 본문 이미지	Developing drugs to combat TB can be frustrating. Volleys of compounds hurled at the essential gene target have little impact on microbial growth. A new study in Cell helped explain why target-based antibiotics have had so much trouble getting off the ground.
TB Clip 2021년 8월호 본문 이미지	Researchers found a gene that helps TB turn off an important immune signaling system in infected human cells. The new finding may point to an effective target for a gene-based treatment or preventative therapy for TB.
TB Clip 2021년 8월호 본문 이미지	TB Alliance and KNCV Tuberculosis Foundation published a study in BMC Public Health, focused on collecting stakeholder views (in Nigeria, Indonesia, and Kyrgyzstan) regarding the acceptability, feasibility, and likelihood of stakeholders implementing the BPaL regimen. BPaL is a three-drug, 6-month, all-oral regimen composed of bedaquiline, pretomanid and linezolid for the treatment of highly drug-resistant forms of TB.
TB Clip 2021년 8월호 본문 이미지	For 70 years, clinicians thought they knew the shape of TB granulomas in the lungs of patients. That long-lived paradigm is now shown to be wrong. New research has created a three-dimensional view of diseased lung tissue from TB patients, using micro-computed tomography. The TB granulomas showed marked heterogeneity in shape, volume and number in the lung sections.
TB Clip 2021년 8월호 본문 이미지	MSF in Khayelitsha, Cape Town, reports “disturbing” diagnosis patterns for rifampicin-resistant TB after the onset of COVID-19. In a letter to The Union, MSF calls for “innovative thinking and rapid and concerted action” to increase diagnostic testing, routine TB screening and household contact tracing for all newly-diagnosed patients.
TB Clip 2021년 8월호 본문 이미지	China has a high burden of rifampicin-resistant TB along with a low detection rate. To address this, the authorities changed strategy in 2015. Researchers looking at the years 2015-19 have found that screening and diagnosis increased significantly. They recommend further measures to close continued detection gaps. Another study assesses the effects of the “China National Health Commission (NHC) and Gates Foundation TB Prevention and Control Project” on the quality of TB care. It concludes that the quality of TB diagnosis services has improved substantially, which is attributable to the coverage of new diagnosis technology. However, “irrational use of second line drugs remains a concern.”
TB Clip 2021년 8월호 본문 이미지	Scientists at Cornell University, New York, say they’ve developed a new method to analyse how individual immune cells react to the bacteria that cause tuberculosis; this could pave the way for new vaccine strategies and provide insights into fighting other infectious diseases around the world. And researchers in Hyderabad say they have achieved new insight into the molecular mechanism of the bacteria that help them evade the human immune system.
TB Clip 2021년 8월호 본문 이미지	A new method that analyzes how individual immune cells react to the bacteria that cause TB could pave the way for new vaccine strategies against the disease, and provide insights into fighting other infectious diseases.
TB Clip 2021년 8월호 본문 이미지	The International Journal of Tuberculosis and Lung Disease (IJTLD) is the official publication of the International Union Against Tuberculosis and Lung Disease. It publishes articles on all aspects of lung health. IJTLD August 2021 issue is available here.
TB Clip 2021년 8월호 본문 이미지	RESIST-TB released its July 2021 newsletter with the latest research publications on drug-resistant TB.

STOP-TB 파트너십은 유엔프로젝트조달기구(UNOPS)가 주도하는 글로벌 결핵퇴치 협력네트워크입니다.