Analysis: Hopes and Entanglement of Anti-tuberculosis Drug Development

Business Club on January 11th TB has always been a lingering nightmare. This disease, which has been entwined by humans for thousands of years, is deeply disturbed by the spread of multidrug-resistant tuberculosis. The few existing therapeutic drugs are old drugs that were invented four to fifty years ago. There is a great need for new drugs and new vaccines against tuberculosis.

In recent years, non-governmental organizations such as the World Health Organization, the Global Tuberculosis Drug Research and Development Alliance, and related pharmaceutical companies have increased their investment in this area, and all governments have also strongly supported relevant research. Associate Professor Lu Yu from the Department of Drug Research of the Beijing Tuberculosis and Breast Cancer Research Institute told the 2010 Beijing Pharmaceutical Annual Meeting held on December 18th that there is currently an upsurge in the development of anti-tuberculosis drugs worldwide, at the stage of laboratory development and clinical trials. Many of the candidate drugs show strong anti-tuberculosis potential. However, these drug candidates still have a long way to go before they actually play a role in the clinic. The challenge remains grim.

"time bomb" potential

Tuberculosis is one of the most important public health problems in the world. The spread of multidrug-resistant tuberculosis and the limitations of existing therapeutic drugs make tuberculosis no different from the "time bomb" that hangs over human heads. Once it is not effectively controlled, the consequences will be disastrous.

It is understood that tuberculosis kills 2 million people each year in the world. Due to the long course of treatment for pulmonary tuberculosis and complicated methods, many patients cannot complete the treatment, and the resistance of the disease continues to increase, becoming an increasingly serious global health threat. Every year, more than 500,000 new cases of drug-resistant tuberculosis occur worldwide. The WHO report on resistance to tuberculosis shows that the level of drug resistance in the general population has reached the highest level, and multidrug-resistant tuberculosis is still spiraling upwards. If this trend cannot be reversed in a timely manner, drug-resistant tuberculosis will lead to an incurable outbreak.

China is one of the high burden countries for global tuberculosis and ranks second in the world. According to figures released by the National Center for Tuberculosis Prevention and Control of the China Center for Disease Control and Prevention on December 14, from 2001 to this year, the incidence of tuberculosis in mainland China has always ranked first in the epidemic of Class A and B, and the annual incidence of active tuberculosis is about 1.3 million, and infectious tuberculosis is 65. Among the 10,000 cases, the number of newly-emerged MDR patients was approximately 120,000, and 9,000 XDR-TB patients. Chen Mingting, deputy director of the center, provided data from the inaugural meeting of the first Chinese Tuberculosis Prevention Public Welfare Work Collection held by the Ministry of Health: In 2009, there were 1,076,938 cases of tuberculosis and 3,783 deaths; two cases of multidrug-resistant tuberculosis, tuberculosis, and HIV were reported. Tuberculosis of infection and mobile population has become the three major challenges facing the prevention and control of tuberculosis in China.

Corresponding to the severe disease situation, the serious limitations of the existing therapeutic drugs. Lu Yu said that currently most of the world's first-line drugs for treating tuberculosis still rely on a few drugs that were invented four or fifty years ago. Second-line drugs are often more expensive and less effective than first-line drugs. They have long course of treatment and efficacy. Poor, serious adverse reactions. Existing drugs cannot kill M. tuberculosis retained bacteria, which is the main reason why tuberculosis cannot be eradicated and causes recurrence. Therefore, in recent years, the research on tuberculosis has largely focused on the study of the biological characteristics of the residing bacteria and on the studies that are more effective in killing the drug of tuberculosis.

The new antituberculosis drugs in the target should be able to shorten and simplify the course of treatment, overcome multidrug resistance, treat tuberculosis and AIDS co-infection, and provide more effective treatment for latent tuberculosis infection. Lu Yu suggested that in order to increase the efficacy of multidrug-resistant tuberculosis, it should focus on the development of new combinations of drugs with unique mechanisms of action. These new drug combinations should be equally effective against MDR-TB. If a drug with a unique mechanism of action does not shorten the course of treatment, it can be specifically developed as a second-line drug for the treatment of multidrug-resistant tuberculosis.

New Hope Asymptotic

There have been no new anti-tuberculosis drugs in nearly 50 years. With the efforts of all parties, it was not until 10 years ago that new drug candidates appeared. Nowadays, with the increase in investment in drug development for tuberculosis, nine possible combinations of anti-tuberculosis drugs consisting of six types of antibiotics are in the research and development stage, and some have already begun clinical trials, making it possible to experiment with anti-tuberculosis combination drugs.

The Global Tuberculosis Drug Research and Development Alliance announced recently that it will conduct its first clinical trial to test new drug therapies. This Phase II clinical trial, called "NC001" or "New Combination 1," tests innovations consisting of PA-824, moxifloxacin and the commonly used antibiotic-resistant pyrazinamide for the treatment of tuberculosis. Drug combination. This combination of three drugs will probably treat drug-sensitive tuberculosis (DS-TB) and multidrug-resistant tuberculosis (MDR-TB). If the clinical trial is successful, it will make the drug treatment time. It is compressed from 2 years to less than 6 months.

Treatment of tuberculosis requires a combination of different pharmaceutical ingredients to prevent the body from developing drug resistance. According to the traditional method, the testing of each new drug in the combination requires researchers to conduct a series of lengthy and expensive clinical trials, which means that a brand-new drug combination needs several decades of research and development. The NC001 test adopts a new research and development method to test together several new drug ingredients in the combination, which greatly shortens the research and development time of new therapies.

NC001 also tested a combination of two other drugs - TMC207/pyrazinamide and PA-824/pyrazinamide - that may be the basis for future new therapies.

However, the development of new therapies requires extensive coordination and cooperation. In order to achieve this goal, the Bill and Melinda Gates Foundation, the Institute of Critical Pathways, and the Global Alliance for Drugs for Drugs and Tuberculosis initiated the key approach to combat tuberculosis in March 2010. The program aims to reduce the time for TB drug development and address other issues facing drug development, including advancing scientific oversight, allowing monitors to evaluate data from new trials. R&D programs may become the new golden rule for tuberculosis research. They can also provide lessons for other diseases that require combination therapy, such as cancer, hepatitis C, and malaria. However, there is a need for funding to bring new anti-tuberculosis therapies into the later phase of clinical trials.

Lu Yu introduced several new drugs at the Beijing Pharmaceutical Annual Meeting. The dihydroimidazooxazole OPC-67683 developed by Otsuka Pharmaceutical Co., Ltd. is conducting clinical trials on the safety and efficacy of Phase II MDR-TB patients; the LL-3858, a pyrrolyl compound developed by Lupin of India, is undergoing multi-center Phase I clinical trials; SQ-109, a diamine compound developed by Sequella, is undergoing Phase I clinical trials.


Global TB Drug Discovery Alliance Tests New Drug Therapy

The Global Alliance for Tuberculosis Drug Development (TB Alliance) announced that it will conduct its first clinical trial to test a novel tuberculosis drug therapy called NC001.

This new combination of three drugs will be used primarily for the treatment of drug-sensitive tuberculosis (DS-TB) and multidrug-resistant tuberculosis (MDR-TB), and is expected to significantly reduce and simplify tuberculosis worldwide The course of treatment shortens treatment time from 2 years to less than 6 months. "To eradicate tuberculosis, we need not only a new drug, but a new treatment plan. China has the world's second largest group of tuberculosis patients and the new therapy will bring happiness to Chinese patients." Global tuberculosis drugs Dr. Ma Zhenkun, chief scientist of the Development Alliance said.

Tuberculosis causes 2 million deaths worldwide each year. Due to the long course of treatment and complicated methods of treating tuberculosis, many patients cannot complete the treatment, and the resistance of the disease continues to increase, becoming an increasingly serious global health threat. Every year, more than 500,000 new cases of drug-resistant tuberculosis occur worldwide. NC001 clinical trials will be conducted in two centers in South Africa with a total of 68 patients, each receiving two weeks of medication and up to three months of follow-up to test the effectiveness, safety, and resistance of the new treatments.

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