Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced it has received feedback from the U.S. Food and Drug Administration (FDA) regarding two ongoing programs.
The FDA recently provided written input on Atossa’s clinical path for oral Endoxifen to reduce mammographic breast density, or MBD. The input was provided pursuant to a pre-IND meeting request which was scheduled for April 30, 2020. The input received from the FDA was very useful and will inform Atossa’s clinical trial strategy and study design both in the U.S. and in Stockholm, Sweden where Atossa is planning a Phase 2 study to reduce MBD. The upcoming study in Stockholm is subject to approval by the European Medical Product Authority (MPA) and the re-opening of mammography clinics in Stockholm following the COVID-19 closures.
“We are very grateful to the Agency for its feedback on the development of our oral Endoxifen program, which will be extremely useful in our continued planning for our upcoming Phase 2 MBD study,” said Steven Quay, M.D., Ph.D., President and CEO of Atossa. “The input from the FDA is essential and guides our continued development of medicines to save lives and meet unmet medical needs. For example, based in part on the FDA’s input, our proposed Phase 2 study will be designed to examine if oral Endoxifen can be used as an adjunct to mammography.”
In addition, Atossa recently applied to the FDA for approval to commence the COVID-19 HOPE Study of Atossa’s proprietary drug AT-H201 which Atossa plans to study to improve pulmonary function in COVID-19 patients on ventilators, reduce time on ventilators and increase survival. The FDA has requested, among other things, that Atossa submit additional pre-clinical and other information on AT-H201 before approving the study. Atossa is in the process of gathering the data and information requested and plans to provide it to the FDA as soon as possible. There can be no assurance that Atossa will be able to provide the information requested by the FDA nor that the FDA will approve the COVID-19 HOPE Study.