This month we interviewed Malcolm Gleser, M.D., Ph.D., CEO of Oricula Therapeutics. This University of Washington tech startup is developing medicines that protect hearing and balance from the effects of ototoxic drugs.
Q: Your first product in development is a medication to prevent hearing loss in patients undergoing treatment with aminoglycoside antibiotics. How frequently are these antibiotics used and for what types of infections?
A: Aminoglycoside antibiotics (AGs) are some of the earliest and most effective antibiotics. They continue to be used worldwide to treat a variety of life-threatening bacterial infections, including pulmonary infections associated with cystic fibrosis, endocarditis, neonatal septicemia, pseudomonas respiratory infections and multiple drug resistant TB, among others.
However, AG use is associated with ototoxicity that results in some level of permanent hearing loss in as many as 20 percent of the two-to-four million individuals treated annually with parenteral AGs. This serious liability has clearly limited the therapeutic utility of this important and cost-effective class of antibiotics. Despite this limitation, based on data provided by IMS Health, there are still more than 500 million patient-days of parenteral AGs given worldwide each year.
Q: In layman’s terms, can you describe how your medication will prevent hearing loss?
A: Although the exact mechanism of action of our compound is unknown, we do know that it prevents aminoglycosides from entering the mitochondria of inner ear hair cells. This seems to be the place that aminoglycosides cause disruption, leading to death of the cell.
Q: What is the potential market for this medication…both in the United States and throughout the rest of the world?
A: Aminoglycosides are administered more than 8 million times annually in the U.S. and 500 million times worldwide. We believe we could achieve an 80 percent penetration in the U.S. market, 50 percent in the rest of the developed world and 20 percent in developing countries, where most of the aminoglycoside use occurs. With reasonable pricing, we believe that the market for our hearing protectant could exceed $350 million per year.
Q: Where are you currently in the development process?
A: We have a lead clinical compound that is 100 percent effective in rats and has passed all of its early safety tests. We are about to begin GLP-toxicology testing of that compound. We believe we are about two years from first-in-human trials.
Q: Where do you stand on funding today, and what are your plans for raising capital over the next 12 months?
A: We are developing this company and product mainly through grant support. Our only capital to date has come from the founders’ investment. We expect to raise a small amount of capital over the next few months to cover working capital needs for the next two years. We expect to pay for GMP manufacturing and GLP safety with grant funding.
Q: Assuming you find a Pharma partner, what is the timeline for getting the product ready for market?
A: We are hoping to begin human trials in two years. An optimistic forecast of progress would get our drug to market two or three years after that. We may try to speed this up by using it first for some orphan diseases such as cystic fibrosis.