Tuberculosis (TB) is an airborne disease caused by Mycobacterium tuberculosis. 25% of the world’s population is estimated to be infected with this pathogen.
There are several types of TB, depending on the organs affected by the disease, but lung TB is the most manifested form. A significant number of patients carry a Latent tuberculosis infection (LTBI). LTBI consists of a persistent immune response (caused by an underlying TB infection) in patients in which no clinical symptoms have manifested. LTBI patients are also subject to treatment, as part of the TB prevention efforts.
For more than 40 years, there have been no new global medicines in the market for treatment of tuberculosis. The new molecules under investigation haven’t yet succeeded in covering all of the expectations, especially in terms of treatment duration shortening and cost.
|First line TB drugs||Year of discovery|
CINARIF® – The project that may change the TB treatment landscape
CINARIF® is a semi synthetic antibiotic belonging to Rifamycins group.
Advantages of the new molecule
The improved characteristics of the CINARIF® compound is expected to be more efficient than current TB antibiotics and ease of treatment for millions of affected patients. This new drug will also present a more economically viable option for health care systems and non-government health promotion organizations in the fight against Tuberculosis.
- Shorter treatment – up to 30% reduction of overall treatment duration (from 6 months to 4 months), which in turn reduces the total treatment cost substantially.
- Greater intermittency of application (two or three admissions per week) compared to Rifampicin - This improvement correlates with significantly better patient compliance, which is one of the major factors determining the success or failure of eradicating the infection in full.
- Our research has shown CINARIF® to be much more effective than Rifampicin against Mycobacterium tuberculosis strains (i.e. it has 10 to 30 times lower MICs for most of the strains we studied). Paired with the toxicological profile our new drug is expected to have lower rates of adverse reactions in patients and therefore increased drug safety and overall patient compliance.
- Price advantages - we do expect the price of CINARIF® to be lower than the other drugs in the Rifampicins group except for Rifampicin. And what is most important - we expect it will greatly reduce the total cost of treatment, which should make CINARIF® a first-line choice in the fight against the TB disease.
KDTB Research LLC is a company established to complete pre-clinical and clinical studies, and to launch CINARIF®– a new molecule for the treatment of tuberculosis. Many years of research on hundreds of molecules led to the development and testing of CINARIF® – an improvement on the previously investigated T-9 and T-11 molecules.
We believe it is the right moment to finalize the trials on CINARIF®. Our team consists of some of the scientists that discovered the molecules, as well as experienced specialists in the fields of R&D, pharmaceutical business and patent law, among others. Our assessment shows that aside from the humanitarian benefits for the millions of affected patients, there is huge market potential for a drug with the characteristics of CINARIF®, which makes the remaining clinical trials economically viable.
We have already done a lot of work
- Two in vitro studies with mycobacterium tuberculosis (Mtb) strains including H37Rv, wild strains of Mtb, atypical mycobacteria, MRSA, etc.
- In vivo acute oral toxicology and intraperitoneal toxicology studies.
- Patents already granted for 71 countries: US (patents Nr. US 9 682 99 7 B2 and Nr. US 9 981 985 B2) , China (patent Nr. ZL2013800532416), EAPO (includes Russian Federation and 7 other countries) - patent Nr. 029363, South Africa (patent Nr. 2015/01268), ARIPO 17 African countries (patent Nr. AP4220), Japan (patent Nr. 6400580), Canada (patent Nr. 2,881,958), Ukraine (patent Nr. 120030) , EPO (EU)- Notice of allowance, India (patent Nr.335237), Vietnam - Notice of allowance, Indonesia- Notice of allowance
- CINARIF® patenting in other countries is underway: Brazil, , Mexico, Korea.
- The production technology is available - the product is a semi-synthetic antibiotic with 6 phases of synthesis
- The production site is already identified – a chemical synthesis pilot plant specifically designed for the production of CINARIF®
- We have developed a detailed business plan, including sales forecast, respective market shares, forecasted cash flow, headcount, balance sheet, P&L for 17 years ahead as well as an investment plan and detailed Cost of goods with all ingredients
- Price policy by country, market access approaches, product roadmap.
- Forecasted cost-effectiveness by countries based on total treatment cost reduction
Dr. Kiril Ditchev, M.D., MBA – KDTB Research Founder, Medical doctor with specialties of Internal diseases and Respiratory diseases, 11 years of clinical practice, 2,5 years in Bulgarian Ministry of Health – National TB program lead, Lung Diseases’ Expert Council’s secretary, monitor of 14 hospitals for treatment of tuberculosis and other respiratory diseases, over 17 years of experience in pharmaceutical business.
Prof. Kiril Ninov, PhD – Chemist, inventor of CINARIF®, former head of Chemical Pharmaceutical Research Institute, Sofia, author and co-author of 40 scientific publications on the synthesis of new active compounds, author of 26 patents for the preparation of medicines, Bulgaria
Dr. Velichka Dimova, M.D., PhD – Medical doctor, pre-clinical and clinical design developer, co-inventor of CINARIF®, 5 years of clinical experience, 18 years pharmaceutical R&D in Chemical Pharmaceutical Research Institute, Sofia – Senior Research Officer (Medico-biological Department, Pharmacology, Chemotherapy), 20 years of product management and medical advisory in a pharmaceutical business. Fields of Research : Experimental and Clinical Chemotherapy, Bioavailability Studies, Experimental Animals Models, Healthy Volunteers, Experimental and Clinical (Comparative) Studies on bioavailability and therapeutic efficacy of new pharmaceutical products (Generic and original) , Drug Master Files, Dossiers, Registration, Expert Reports. Author and co-author of 120 scientific publications, including all the publications regarding T9 and T11 compounds, Bulgaria
Prof. Petko Minchev, M.D., D.Scs. - Scientific consultant of the project , Medical doctor with specialties of Pediatric diseases, Respiratory diseases and Pediatric respiratory diseases, National consultant of pediatric respiratory diseases and tuberculosis, Head of Bulgarian Association of pediatric respiratory diseases, author of 228 scientific publications, author of four books (including "Clinical tuberculosis") and one patent , Member of European respiratory society, Bulgaria
Mr. Kevin Smith – Financial consultant, over 25 years of financial experience in pharma business including as CFO, GM for the companies Actavis, Wellcome & Merck, UK
Prof. Evtimia Ivanova Velikova – Stefanova, Master of Pharmacy, former Head of Division for Drug Dosage Forms in Chemical Pharmaceutical Research Institute, Sofia, Bulgaria. Fields of Research: hard drug dosage forms, studies on the physical-chemicals and rheological characteristic of the drug substances, granules and tableting mixtures, studies of the biopharmaceutical characteristics of drug release and development of sustained and modified release dosage forms. Author of more than 75 scientific publications, 52 patents, 46 scientific reports and more than 163 technologies for different dosage forms all of them produced currently in the Bulgarian pharmaceutical plants.
Mr. Martin Paev, CFA, Investment consultant - a Founder and Chairman of SORTIS GROUP with 20+ years of investment banking, M&A, private equity and asset management experience. Holds a Master’s degree in Banking and Finance and a Bachelor’s degree in Business Administration. He is a CFA® Charterholder, a member of CFA Institute (USA) and a licensed appraiser of companies, receivables and real estate. Previously worked at ING Barings (Frankfurt-am-Main, Germany) and then for ETEBA (investment bank of National Bank of Greece) and Balkan Advisory Company (investment banking boutique). Mr. Paev structured and managed the first Real Estate Investment Trust in Bulgaria (TBI-BAC REIT) and then was Executive Director of Address Invest, the investment arm of AG Capital, the largest Bulgarian real estate advisory firm. He also is a chairman of the Board of Directors of Cremio, a leading European manufacturer of vegetable cream and milk. He is a regular speaker at private equity and investment conferences for Central and Eastern Europe.
Dr. Petko Ditchev, MD – graduate of the Medical University of Sofia, programmer and AI researcher
Mrs. Valentina Nesheva – Chemist and Lawyer, Intellectual property consultant, Bulgaria