Last Updated on January 14, 2024 by The Health Master
The Indian Patent Office (IPO) has granted a patent application submitted by the National Institute of Pharmaceutical Education and Research (NIPER), Mohali, for the rights of a compound as an anti-tubercular agent and an improved process for its preparation, which is envisaged to overcome the shortcomings of the existing drugs.
The patent office has granted a patent to the invention titled “Novel 2-(2′-Aminophenyl) benzazoles as potential anti-tubercular agents and improved process of preparation thereof,” for which an application was filed by the NIPER on September 10, 2015.
A hearing was held on May 20, 2022, and based on the discussions during the hearing, the institute was asked to amend the claims and submit them within 15 days from the date of the hearing.
“In view of the amendments and also of the elaborative hearing submissions (oral as well as written), all the other requirements raised in the hearing notice are met.”
“The said objections are therefore rendered moot. The submission as submitted was found to be satisfactory and convincing, therefore accepted,” said the Assistant Controller of Patents and Designs, in the order issued on October 7. According to this, the patent application was granted with 13 claims as submitted on June 1, 2022.
“The present invention relates to the field of biochemical science and provides novel heterocyclic compounds as anti-tubercular agents and an improved process for the preparation thereof.”
“Particularly, the present invention relates to 2-(2′-aminophenyl) benzazole such as 2-(2′-aminophenyl) benzoxazole, 2-(2′-aminophenyl) benzimidazole and 2-(2′- aminophenyl) benzothiazole compounds,” said the complete specification submitted by NIPER as part of the patent application process.
It says that tuberculosis (TB) is a disease of antiquity caused by infection with members of the Mycobacterium tuberculosis complex, among which M. tuberculosis organisms are the main pathogens infecting more than one-third of the world’s human population, as of 2013.
It is an airborne disease, affecting millions of people each year, which makes it the second leading cause of death worldwide, after the human immunodeficiency virus (HIV).
In spite of effective chemotherapy and the directly observed treatment short-course (DOTS) strategy for its treatment, the battle to combat TB is not resolved.
In 1993, the WHO declared TB “a global health emergency”. The recalcitrant nature of the persistent infection and the increase in multi-and extensively drug-resistant (MDR-TB and XDR-TB) are the main challenges to the effective treatment of TB with currently available anti-TB drugs.
The recommended DOTS therapy for TB is a regimen that consists of four drugs: isoniazid (INH), rifampicin (R), pyrazinamide (Z), and ethambutol (E)-taken daily for 2 months during the ‘intensive’ treatment phase, followed by two drugs: INH and R-taken daily for 4 months in the ‘continuation’ or sterilizing phase.
The lengthy treatment, lack of drug supply, underdeveloped health care, and inappropriate drug prescription or dose lead to increasing the risk of resistance development, and many of the existing drugs have acquired resistance and cross-resistance with each other.
A handful of drugs are used to treat MDR-TB and XDR-TB for long periods to prevent relapse of TB.
“Accordingly, there is an urgent need for new anti-mycobacterial drugs, and in particular for novel agents that will shorten the duration of tuberculosis chemotherapy, or overcome drug-resistant strains of the causative organism, M. tuberculosis,” said the institution in the document.
As a part of the investigation of new chemotherapeutic agents for tuberculosis from this laboratory, the research efforts have been focused on the development of new scaffolds with good anti-mycobacterial activity and finally to develop of new anti-tubercular agents that can improve the current therapeutic regimen.
“Many anti-TB drugs such as INH, Z, and PAS (para-aminosalicylic acid) have an additional nitrogen atom/nitrogen-containing group along with the amide/ester functionality. The oxazole group serves as the latent amide/carboxylic acid functionality. “
“Thus, the oxazole moiety can be considered a new pharmacophoric feature in designing new anti-TB compounds. This led to the introduction of the nitrogen-containing group in the benzoxazole moiety for designing a new anti-TB scaffold,” it said.
Benzoxazoles and their bioisosteres Benzothiazoles are an important class of heterocyclic compounds that can be considered as structural bioisosteres of naturally occurring nucleotides (such as adenine and guanine) and interact easily with the biopolymers of a living system. Several benzoxazoles and benzothiazole molecules have been reported in the literature to possess anti-TB activity.
“These findings encouraged us to design and synthesize new 2-(2′-aminophenyl) benzazoles, which were then tested for activity against tubercular cultures,” according to the patent specification from NIPER.
According to the India TB Report 2022, released by the ministry of health and family welfare, the year 2021 witnessed a 19% increase from the previous year in TB patients’ notification—the total number of incident TB patients (new and relapse) notified during 2021 was 19,33,381, as opposed to that of 16,28,161 in 2020.
As per the Global TB Report 2021, the estimated incidence of all forms of TB in India for the year 2020 was 188 per 100,000 population (129-257 per 100,000 population).
The estimated mortality rate among all forms of TB was 37 per 100,000 population (34–40 per 100,000 population) in 2020, as per the Global TB Report 2021.
There has been a slight increase in the mortality rate due to all forms of TB between 2019 and 2020 by 11% in the country.
In absolute numbers, the total number of estimated deaths from all forms of TB excluding HIV, for 2020 was 4.93 lakhs (4.53-5.36 lakhs) in the country, which was 13% higher than of the year 2019 estimate, it added.
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