Tuberculosis overview

Tuberculosis (TB) is an airborne disease caused by Mycobacterium tuberculosis. About 25% of the world’s population (1.7 billion people) is estimated to be infected with Mycobacterium tuberculosis.

In 2018, 10 million people fell ill with TB and 1.4 million died from TB (2019 WHO Global TB report). TB is one of the top 10 deadliest diseases in the world.

TB has different types depending on the affected human organs but majority of the cases are cases with lung TB. Tuberculosis treatment usually lasts 6-9 months (for drug susceptible TB) and 18-24 months (for drug resistant TB).  A significant percentage of the patients carry the so called Latent tuberculosis infection (LTBI). LTBI is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis (MTB) antigens without evidence of clinically manifested active TB. These patients need treatment with TB drugs as well.

Tuberculosis is a medical, social and political challenge which requires the collective efforts of our society in order to decrease prevalence, incidence and mortality. It’s a disease of the poor people and poor countries but high and upper middle income countries are also affected. Starting in the early ’90s the World Health Organization (WHO) established TB programs and respective structures  in most of the countries in the world.  This resulted in substantial reduction of TB incidence and increasing of treatment success rate. WHO releases annual reports reflecting the state of TB around the world. In 2018, according to WHO analytics, the tuberculosis estimated incidence was 10 million people per year (the number of new and recurrent (relapse) episodes of TB (all forms) occurring in a given year). 6,9 million were reported which is 69% of estimated incidence.

Despite indisputable WHO success against TB, there are still some challenges which WHO and society face. They could be summarized as follows:

  1. Medical specialists rely on old drugs, discovered in the ’60s and ’70s. Although clinical trials have been conducted in the last 7-10 years, most of the new molecules are designed to treat mainly Multi-drug resistant tuberculosis (MDR TB) which accounts for 5% of TB cases.
  2. Treatment success rate varies but the global average is  85%. Insufficient treatment could be a consequence of treatment interruption, lower doses, reduced patient compliance, organizational issues, difference between private and state hospital financing, other finance issues, etc.
  3. Drug resistance: multiple factors contribute to the development of drug resistance – nature of the disease, healthcare systems’ organization, doses, regimens, drugs quality, insufficient patient adherence to the treatment, the nature of MTB genome and its mutations, among others. Multiple-drug resistance (MDR) is one of the biggest threats that the human society and health care systems will continue to face in the coming years.
  4. Easier transmission of the infection due to urbanization and migration: The long latent period (when no clinical manifestations are present) of TB makes it very hard to control the spread of the disease across borders and communities.
  5. Funding shortage at the global and state level – according to WHO, the funding gap amounts to 2,5 billion USD annually. This number may well be higher, because some countries provide insufficient information about the TB medication cost and especially  co-payment levels, productivity loss cost, etc.. The first WHO global ministerial conference was held in November 2017 in the Russian Federation. The conference brought together over 1000 participants from 120 countries and over 800 partners.  Substantial National Tuberculosis Program budgets’ increasing was committed  during the conference among the other commitments. It was included in 2018 Global TB report.
  6. TB is estimated to cost world USD 1 trillion in lost economic output by 2030.

WHO “End TB” is an  program that aims to reduce TB incidence by 90% until the year 2035. This program is ambitious and needs new tools and additional efforts in order to be successful. Such as:  earlier, affordable and accessible diagnostic tools, shorter and safer treatment, LTBI detection and treatment, affordable treatment cost of all TB forms and types, improved healthcare systems’ organization, better case detection, etc.

Our vision is that society needs two types of new drugs against tuberculosis:

Type 1: Affordable new products for drug susceptible TB appropriate for all regimens, shortening the treatment. This will improve patient adherence and will allow better control of the disease. As a consequence MDR TB cases will decrease.

Type2: Special drugs for DR and MDR TB with minimal side effects also shortening the treatment. An excellent opportunity in this regard is development of a common product with CINARIF®  plus other RNAP blockers. Our company started a project in that direction.