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Atossa Therapeutics Receives Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID
Safety Committee Allows Enrollment in First 14-Day, Multi-Dose Study Arm SEATTLE, Sept. 17, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS),
About this update from Atossa Therapeutics, Inc.
[{"type":"text","content":"Safety Committee Allows Enrollment in First 14-Day, Multi-Dose Study Arm\nSEATTLE, Sept. 17, 2020 (GLOBE NEWSWIRE) -- 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 a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug). The blinded, positive assessment by the safety committee allows the study to now enroll the next cohort, which will be the third of a total of four cohorts and the first of two multi-dose, placebo controlled cohorts.\n “This second favorable safety review marks an important milestone in this study as half the participants have now been dosed and initial safety reviews have been successfully completed,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “Based on rapid enrollment in the first half of the study, we expect to complete enrollment in the remainder of the study very quickly. Recent data from the CDC suggests that more than 90% of people testing positive for COVID-19 do not require hospitalization. With this in mind, we are developing our AT-301 nasal spray for home-use because there are no currently FDA-approved treatments to help these patients with early disease to recover faster.” Significant advances have been made in the field of COVID-19 diagnostic testing. These tests are now much more widely available and they can render results much more quickly. Atossa plans to identify potential partners who are developing these tests so that AT-301 nasal spray may be co-developed and commercialized with the goal of making the AT-301 therapy available at the time a person tests positive for the coronavirus. Atossa also plans to develop its nasal spray to potentially help prevent COVID-19 infection, particularly for people in high risk communities and those working in higher-risk areas, including healthcare workers, emergency responders and teachers. “We anticipate that our AT-301 nasal spray will complement any traditional COVID-19 vaccin...