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Atossa Therapeutics Completed Part C Dosing In Phase 1/2a Study of AT-H201 in Healthy Volunteers – $ATOS $XBI $IBB

By John F. Heerdink, Jr.
RADIATION INDUCED LUNG INJURY (RILI) is damage to the lungs caused by ionizing radiation administered to treat cancer. RILI is a significant issue for patients undergoing radiation treatment for various forms of cancer and is often irreversible. For instance, RILI affects 30-40% of lung cancer patients, and ~35% of esophageal cancer patients. In non-small cell cancer patients receiving concurrent chemotherapy and radiation therapy the incidence of RILI is estimated to be greater than 60%. Although Atossa has not finalized the protocol for this new trial we believe RILI affects a significant number of patients across multiple cancer types and there is a meaningful need for new treatments.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) a clinical stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, announced on July 28th that it has completed dosing participants in Part C of its Phase 1/2a clinical study of its proprietary inhalation therapy (or, AT-H201) in Australia. AT-H201 consists of two drugs previously approved by the FDA to treat other diseases. AT-H201 is intended to be inhaled via nebulizer with the goal of preventing or reducing lung injury that may be caused by fibrin deposition, fluid build-up and secondary infection.

Part C of the study involved administering the two drugs in succession in healthy volunteers. The study originally included a Part D which was designed to assess the effects of the treatment regimen in hospitalized COVID-19 patients with moderate illness. However, due to the rapidly shifting COVID-19 treatment landscape and the introduction of effective vaccines limiting hospitalizations, Atossa has evaluated indications for AT-H201 beyond COVID-19 patients, including treating and/or preventing lung injury in patients undergoing certain cancer treatments.

Rather than conducting Part D of the Phase 1/2a clinical study, Atossa now plans to shift the development of AT-H201 to closely align with its oncology focus by continuing the development in patients with compromised lung-function due to the damaging effects of cancer treatment. For example, radiation treatment can lead to radiation induced lung injury, which is poorly treated with current therapies and is often irreversible. Furthermore, radiation damage can limit the overall success of lung cancer treatment leading to a reduction in efficacy and poor disease control. AT-H201 has pharmacological properties to potentially curtail excessive radiation-induced lung injury without compromising standard of care cancer therapy for cancer patients. AT-H201 is designed to prevent and reduce dose-limiting toxicities, and enable a more durable therapeutic tumor response for cancer patients receiving pulmonary radiation.

“We are happy to have completed Parts A, B and C of the clinical trial and look forward to evaluating the results. With widespread availability of SARS-CoV-2 vaccines and other therapies now approved to treat COVID-19, we believe that altering the development pathways for AT-H201 in patients with compromised lung-function resulting from radiation may fill a compelling unmet medical need and create more value for our stockholders. Based on our work to date with AT-H201, we believe we can quickly initiate a clinical study in this setting and we plan to announce our next steps in the fourth quarter,” stated Steven Quay, M.D., Ph.D., CEO and President of Atossa.

On July 28th, Jason McCarthy Ph.D., a biotech analyst at The Maxim Group, put out a research note reconfirming his BUY rating and a $4 target price on Atossa Therapeutics (ATOS). 

Learn more about Atossa Therapeutics (NASDAQ: ATOS) at Atossa’s website: https://atossatherapeutics.com.

(Read Original Story: Dosing Completed in Part C of Atossa’s Phase 1/2a Study of AT-H201 in Healthy Volunteers in Atossa Therapeutics, Inc. (Nasdaq: ATOS))


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