Idiopathic pulmonary fibrosis (IPF) is a devastating disease of unknown etiology characterized by progressive fibrosis of the lungs leading to respiratory failure and death with a median survival of about 3 years consequent to diagnosis. At NOXON we are developing a novel drug for oral treatment of fibrotic lung diseases. This drug, 3-cabamoyl-proxyl (3-CP), is a stable organic radical belonging to the nitroxides group. Nitroxides have long been known to protect from injury associated with oxidative damage in laboratory animals.
Pulmonary fibrosis is a feature of many diseases involving the lung parenchyma, including drug-associated and occupational lung injury as well as various fibrotic diseases of unknown cause and with variable clinical behavior. The most devastating of these is Idiopathic Pulmonary Fibrosis (IPF), a disease of unknown etiology, characterized by progressive fibrosis of the lungs. Ongoing damage to the lungs makes it progressively more difficult to breath leading to severe disability, respiratory failure, and death with a median survival of only 2–3 years.
Our product, 3-CP , which has a unique antioxidant property, has been shown to to reduces airway inflammation, airway hyper-responsiveness, and other inflammatory mediators of the lung tissues as was seen in animal models of allergic asthma. Nitroxides have been shown to effectively protect cells, tissues, organs, and whole laboratory animals from radicals-induced damage. Fibrosis a debilitating outcome of lung tissue inflammation due to free radicals, was shown to be attenuated by the use of 3-CP in animal models. The drug is intended for oral administration yet it was also shown to be effective when used in other routs of administration. 3-CP has high margin of toxicity and is less likely to cause side effects.
IPF has an estimated prevalence of 13 to 20 per 100,000 people worldwide. About 30,000 to 40,000 new cases are diagnosed every year in US alone. The global market size of IPF was valued at $ 3.7 billion in 2021, and is projected to reach $ 5.7 billion by 2027, registering a CAGR of 7.55% from 2022 to 2027. The market size of IPF is only a fraction of the potential drug market size since there are other lung fibrosis diseases. Nearly 5-10% of the asthma patients develop severe disease associated with structural changes and fibrosis of the airway. The current market for the treatment of lung fibrosis is rather limited.
To date, the only definitive treatment for IPF and other progressive fibrotic lung diseases is lung transplantation. This option is obviously not possible for patients who are elderly, have severe comorbidities or do not have access to transplant.
Currently, there are two FDA approved medications for IPF, pirfenidone (Esbriet) and nintedanib (Ofev). These drugs do not cure IPF or other fibrotic diseases, but at best slow disease progression. These drugs are expensive, have significant side effects and are not approved for the treatment of patients with advanced disease. Thus, a large proportion of IPF patients remain without treatment.
Therefore, there is an urgent unmet medical need for the development of safe and effective new treatments for IPF and NOXON intends to set a placeholder in such market, for the development of novel approaches for combating this devastating disease.
Dr. Firas Younis (CEO), has a Ph.D. pharmacology and pharmaceutical sciences from the Tel Aviv University. He has more than 15 years of experience in planning and initiating projects, starting from proof of concept up to first in human studies. Dr. Younis, has vast experience in drug discovery and development process, with a focus on the drugs pharmacological and pharmacokinetics aspects as well as, monitoring bioanalytical analysis development for an API. Dr. Younis also has experience in the regulatory document writing, including INDs, IB, and NDA.
Prof. Sara Goldstein, (Entrepreneur and scientific advisor), Head of the Accelerator Laboratory, Chemistry Institute, Hebrew University of Jerusalem. Ph.D. from the Department of Physical Chemistry, Hebrew University of Jerusalem. Specialized in radiation chemistry, chemistry and biology of nitroxides, and reaction mechanisms of reactive oxygen and nitrogen species with biological target molecules.
Prof. Neville Berkman, (Entrepreneur and scientific and clinical advisor), Director, Department of Pulmonary Medicine, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem. MBBCH (MD) from University of Witwatersrand (Johannesburg). Prof. Berkman is one of the leading physicians in Israel in the field of Pulmonary Medicine. His basic science research work is relating to severe asthma and to fibrotic diseases of the airways and lungs. He has extensive experience with murine models of lung disease.
Prof. Amram Samuni, (Entrepreneur and scientific advisor), Emeritus Prof. in the Institute of Medical Research, Israel-Canada, at the Medical School of the Hebrew University of Jerusalem. Fields of interest include reaction kinetics, free radicals, mechanisms underlying chemical reactions, red-ox reactions, metal-catalyzed specific injury, chemistry and biology of nitroxide stable radicals.
Dr. Taher Nasar, (Technology consultant), Senior Research fellow, Department of Pharmaceutics, Hebrew University of Jerusalem. Ph.D. in pharmaceutical science, Hebrew university, School of pharmacy. He has more than 20 years of experience in drug delivery, small molecule drug discovery, drug target development, assay development, new drug discovery, drug synthesis, nanoencapsulation and controlled release.