We are in the midst of a pandemic caused by the virus Covid2, with US now the epicenter of the disease. There is no treatment for the disease although the search is on for a vaccine. The lethality of Covid2 infection is caused by a runaway immune response. We have a novel treatment based on blocking key steps in the inflammatory process. We have much evidence for the efficacy of our lead compound Pevinib-dE in stopping the progress of the disease and reversing damage caused by it in in vivo models of inflammation and pathogen-induced cardio-pulmonary inflammatory disease.
Startup, carrying out major R&D activities including drug design, target validation, mechanism of action, non-GLP toxicity studies, in vivo studies on various aspects and types of inflammation, accelerated tissue repair and prevention of scarring. We have conducted a IRB approved double blind study on accelerated repair with prevention of scars in a cohort of 50 patients. Taken together our data show a high probability of success for our approach in countering the lethality of Covid2.
In view of the expanding pandemic, there is a worldwide need for our treatment.
Problem or Opportunity
I have been developing treatments for inflammatory diseases for several years, using self-funding. Collaborative studies with Fukuoka University in Japan has led to the development of a treatment for a pathogen-induced pan-vascular and cardio-pulmonary inflammation that is often fatal. This treatment is ideally suited to counter the lethal injuries inflicted by a runaway immune response to Covid2 virus. As we know the Covid2 pandemic has affected every part of the world. Much effort is being made to develop vaccines against a constantly mutating virus, but none is expected in the near future. There is the sole effort to counter the disease caused by Covid2, rather than the virus itself.
Solution (product or service)
My solution to this catastrophic viral infection is to address the damage caused by the body's response to the virus. I developed a new class of allosteric inhibitors of NF-kB to block inflammation. There is no comparable technology available. My compounds are NON-TOXIC, water soluble, cell permeable and ideally suited for delivery by infusion in Covid2 patients. These compound have been tested for efficacy in a variety of diseases including fibrosis, inflammation, cancer, pain, and they promote rapid repair in damaged tissues with no scarring. Translated to Covid2 disease, these compounds will block the spread of inflammation and injury and repair and restore injured tissues. My compounds are needed whether or not a vaccine or an anti-viral drug becomes available because they alone address the disease mechanism. Our lead compound Pevinib-dE will be the first in the market to address the damage caused by the virus. There is great need for this treatment as the disease continues to spread.
Earlier discussions with US FDA suggested that this class of molecules will not require major PK/PD studies, nor will they cause immune dysfunction or toxicity.
None at present
Advantages or differentiators
Our platform technology is unique and novel.
We are the only organization seeking to treat the disease, not to develop a vaccine against a moving target (mutating virus), nor are we developing a viricide.
We need the first round of investment (5000000) further to test the treatment in a virus infection model. We are in contact with a non-US organization to conduct studies using monkeys in preparation for an early approach to FDA and international regulatory bodies to bring the treatment to patients as early as possible.
Our business model is to develop the treatment to the extent that we can initiate the IND process. Once we file IND, we will either seek additional funds for human clinical trials or seek strategic partnership with major pharmaceutical companies, or opt for an IPO.
Money will be spent on
Manufacture and formulation of dosage form
Additional studies on Covid2-infected monkeys and other animals, FDA-required pre-clinical studies for IND submission
Consultants, biostatisticians, R&A specialists
Laboratory space rental, equipment and supplies
1.5 FTE research technicians
Travel as required for offshore monkey studies
Offer for investor
Will be determined by negotiation depending upon the size of investment
In developing drugs, the greatest risk is to the patient, that the drug may not work as expected, or cause adverse reaction. Based on our previous studies and the nature of our compounds we know that there is little risk of adverse reaction. That brings us to the first point, that the drug may not work as expected. We have enough confidence to state that there is not a serious possibility of the drug not functioning. The drug metabolizes into normal physiological metabolites that become part of the body. There will not be any fragments or altered compounds that would affect the liver, lungs, kidneys, or any other organ.
Incubation/Acceleration programs accomplishment
Won the competition and other awards
International Application No.: PCT/US2015/052467
European Patent Application No.: 15844064.4
Pending U.S. Application No.: 15/982,837
US Patent 10,030,048 B2 Inhibitors of NF-kB Activity for Treatment of Diseases and Disorders
US Patent US20160000682A1 Peptide-Based Compositions and Methods of Use