The Silicon Review
One of the most significant parts which redefine the characteristics of the pharmaceutical industry is continuous innovation. New medications are responsible for maintaining the quality of human life, and also its sales potential is enormous in the global pharmaceutical market. Innovators are often pressurized to succeed, even though pharmaceutical innovation is hardly a predictable process. There is a need for innovation in modern drug development because even though there is a huge potential for innovation, the segment is still stagnant with no new breakthroughs. It is important for an organization to completely understand the various factors that will fuel drug innovation as it is important for both the future of the organization and healthcare.
Globally, there are various companies pioneering in the drug development field, but one that stands out from the rest is Atossa Therapeutics. The company is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need. Atossa’s current focus is on breast cancer and COVID-19. We believe our innovative therapies and delivery methods can benefit COVID-19 patients and transform breast cancer treatment – with the goal of preventing breast cancer from developing in the first place. Atossa Therapeutics was founded in 2009, and it is based in Seattle, Washington.
In conversation with Steven Quay, CEO of Atossa Therapeutics
Q. Tell us about your COVID-19 therapeutic programs that are under development.
Our two COVID-19 drugs under development are AT-H201, to improve lung function of moderate to severely ill, hospitalized COVID-19 patients by inhalation, and AT-301, a nasal spray for COVID-19 patients who are not as severely ill to require hospitalization. AT-301 is intended for at-home use to reduce symptoms of COVID-19 proactively and to slow the infection rate so that a person’s immune system can more effectively fight COVID-19. We also intend to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2, with the goal that it could complement any traditional vaccine that may be developed in that a traditional vaccine may not be effective in all people and may not be taken by all people.
Q. Will the eventual approval of a traditional vaccine for COVID-19 diminish the market for the COVID-19 therapies you are developing?
We don’t believe so. The FDA has indicated that a COVID-19 vaccine must be effective in at least 50% of people taking it. Surveys have shown that up to 35% of Americans will not take a COVID-19 vaccine. Based on these realities, we are not likely to achieve herd immunity any time soon. Moreover, one interesting implication of this is that when a vaccine is developed, people will have a false sense of protection, which will itself lead to increased infections. In addition, although vaccines are developed every year for the flu, and many people take them, there is also a multi-billion dollar market for flu therapies. So, we believe there will be a tremendous opportunity for Atossa’s therapies, even if a vaccine is developed.
Q. Why does it take so long to get a new drug approved? And why are drugs so expensive?
Many factors contribute to the long timeline and high cost of drug development. Multiple, high-quality clinical studies are very time-consuming. These studies must typically be performed sequentially rather than in parallel; for example, pre-clinical studies must typically be conducted before studies in humans, and safety studies must typically be conducted before studies that are designed to show efficacy. Efficacy studies must generally achieve statistical significance as well as clinical significance – i.e., they must demonstrate the drug is beneficial in practice. For all these reasons, it is very time-consuming and expensive to develop drugs. At Atossa, we try, to the extent practicable, to expedite the development process and minimize costs, particularly early in the development cycle.
Q. Securing proper funding for research is always an uphill task. How do you manage the financial aspect of drug discovery and development?
As a NASDAQ-listed SEC reporting company, we have access to the U.S. capital markets, and fortunately, those markets have been strong in recent years. We are developing drugs for our greatest health challenges – COVID-19 and breast cancer, which has generally appealed to the healthcare investment community.
Q. Regulatory requirements and commitments have increased progressively over time and this has led to an increase in both the trial size and the length. Tell us about your compliance system.
Our philosophy is to conduct only the highest quality studies that we believe will ultimately be accepted by the U.S. FDA. We have been conducting studies in Australia and Sweden, where the costs are typically lower than in the U.S. Moreover, these studies are being managed by very reputable and experienced organizations, and we have a high degree of confidence that our studies will be timely, well-executed, and ultimately supportive of regulatory approval here in the U.S. and in other major commercial centers.
Q. Talk about your commitment towards drug safety.
Drug safety is paramount and dominates everything we do – from sourcing drug supply to conducting clinical studies. We are committed to cGMP, a comprehensive quality program, and to conduct the highest-quality studies of our drug candidates.
Meet the leader behind the success of Atossa Therapeutics
Steven Quay is the CEO of Atossa Therapeutics. Steven received his M.D. and Ph.D. from The University of Michigan, was a postdoctoral fellow in the Chemistry Department at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-MGH Hospital, and spent almost a decade on the faculty of Stanford University School of Medicine. A TEDx talk he delivered on breast cancer prevention has been viewed over 200,000 times. His 300+ contributions to medicine have been cited over 9,900 times, placing him in the top 1% of scientists worldwide. He holds 87 US patents and has invented seven FDA-approved pharmaceuticals which have helped over 80 million people.