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PROGRESS REPORT: Atossa Therapeutics (Nasdaq: ATOS) Announces Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed For Coronavirus Causing COVID

By John F. Heerdink, Jr.

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, 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. Recently, significant advances have been made in the field of COVID-19 diagnostic testing where 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.

Today, Atossa Therapeutics, Inc. announced a positive interim safety assessment from the second cohort of healthy participants in their 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. The ongoing Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B is a multiple-dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation. The study is being conducted in Australia.

“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. 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 the early disease to recover faster. We anticipate that our AT-301 nasal spray will complement any traditional COVID-19 vaccine that may be developed,” added Dr. Quay. “A traditional COVID-19 vaccine may be effective in as few as half of the people taking it and recent surveys indicate that as many as one-third of Americans may choose not to take any COVID-19 vaccine once one becomes available. In addition, studies of re-infection with the coronavirus suggest that the durability of immunity, whether from an actual infection or a vaccine, may not be ideal. As a result, therapies such as our nasal spray, similar to therapies working in tandem with vaccines for seasonal flu, may form an important part of a broader response to the coronavirus pandemic,” stated Steven Quay, M.D., Ph.D., Atossa’s President, and CEO.

Atossa Shares

Shares Of Atossa Therapeutics (ATOS) are currently trading at $2.38/share up 5.78%. 52-week range $.755 – $5.08. 

Analyst Coverage Update

  • The Maxim Group’s Analyst Jason McCarthy, Ph.D. updated his research on Atossa Therapeutics stating “Factoring in COVID-19 Candidates, awaiting HOPE Study Initiation as Pandemic Continues – Raising His Price Target to $8 from $4. 
  • Ascendiant Capital Markets’ Analyst Edward Woo, CFA initiated coverage today with BUY Rating and a $7.00 Target

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(Read Original Story: Atossa Therapeutics Receives Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID in Atossa Therapeutics (NASDAQ: ATOS))


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