Tuberculosis overview
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.
The fight against tuberculosis is a medical, social and political challenge, that we have yet to explore
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 |
| Isoniazid | 1952 |
| Rifampicin | 1966 |
| Rifapentine | 1965 |
| Rifabutin | 1975 |
| Pyrazinamide | 1952 |
| Ethambutol | 1961 |
| Streptomycin | 1944 |
Read more about the current state of research and development in the field
CINARIF® – The project that may change the TB treatment landscape
CINARIF® is a semi synthetic antibiotic belonging to Rifamycins group.
Scope
CINARIF® is created mainly to cure all forms of drug susceptible TB and Latent Tuberculosis Infection (LTBI) but it is expected also to be applicable in some drug resistant cases and in patients with HIV comorbidity.
History
Development started in late 90’s investigation of its predecessors T-9 and T-11, which underwent in vitro and in vivo pre-clinical studies with mice, rats, rabbits and quinea pigs. PK, acute, subacute and chronic toxicology, enbriotoxicity, teratogenicity have been also investigated. One Phase II clinical trial with 60 people has been conducted. All the data are published in scientific magazines and specialized congresses posters. Summarized data about T-9 and T-11 studies could be seen in the article: “Experimental and Clinical Studies on Rifacinna® – The New Effective Antituberculous Drug (Review), Recent Patents on Anti-Infective Drug Discovery, 2010, 5, 76-90”
Development and patenting
CINARIF® is developed in Bulgaria, EU.
Patents already granted for 53 countries including USA, India, China, Indonesia, EPO, EAPO, ARIPO, Vietnam, Japan, etc.
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) in standard regimen, 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.
Rifampicin comparison
About us
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.
If you're a researcher or investor that's interested in the project don't hesitate to contact us
We have already done a lot of work
- In vitro studies with mycobacterium tuberculosis (Mtb) strains including H37Rv, wild strains of Mtb, Non-tuberculosis mycobacteria, MRSA, CYP induction, etc.
- In vivo acute oral toxicology study.
- Patents already granted for 53 countries: US, China, EAPO (includes Russian Federation and 7 other countries), South Africa, ARIPO (17 African countries), Japan, Canada, Ukraine , EPO (EU), India, Vietnam, Indonesia, Brazil, Mexico, Korea.
- The production technology is available
- 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
Our team
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 20 years of experience in pharmaceutical business.
Filip Svetoslavov, MSc, MSc
Production, RA, R&D, Global PT and Global MS&T, 20+ Years of international experience at leading positions, with increasing responsibilities in Production, RA, R&D, PT and MS&T functions in Pharmaceutical Industry. Achieved over 100 MA approvals and commercialization of the generic and original products, including new process and analytical technologies for drug delivery. Successful and practical experience in the international product development regulatory field, including submission strategy creation and US FDA F2F “Paragraph IV Certification”. Master’s degree in Chemical engineering and technologies and Master’s degree in Biotechnology of medicinal products
Elena Radoiova
ACCA
CFO, 26 years of financial experience on different positions in KPMG, Actavis PLc (currently Teva), Alvogen (currently Zentiva), Financial controlling, Financial Reporting, Financial management and budgeting.
Assoc. prof. Velichka Dimova, M.D., PhD – Medical doctor, pre-clinical and clinical design developer, co-inventor of CINARIF®, 5 years of clinical experience, 26 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
Ketty Tsvetkova, RA&Quality Assurance – Chemical engineer with 25+ years of experience in RA and Quality assurance on positions of Head of Regulatory Department, and Regulatory Compliance Officer (Actavis pls currently Teva Pharmaceuticals), Quality Manager and National Qualified Person of Roche Bulgaria, GMP Quality Assurance Lead for iCEE & CIS/UA clusters (Noartis), Founder, CEO and Qualified Person of KeVaRo Group EOOD, Chairman of the Executive Board of Bulgarian QP Association.
Specialized in the field of: GMP/GDP/GCP/ GCLP Audits and Pre-inspections; QP certification and release (sterile, non-sterile, biological commercial products); Planning, budgeting and implementation of company’s registration strategy; Preparing CMC part of Registration Documentation; Quality overview of whole registration dossiers; Coordination of Regulatory Documentation compilation process;
Dr. Petko Ditchev, MD – graduate of the Medical University of Sofia, software developer with experience in building information systems and AI researcher in neuron nets, data science and systems for image and audio analysis.
Advisors
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. Kevin Smith – Financial consultant, over 25 years of financial experience in pharma business including as CFO, GM for the companies Actavis, Wellcome & Merck, UK
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.
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
Mrs. Valentina Nesheva – Chemist and Lawyer, Intellectual property consultant, Bulgaria
Partnerships and funding
