Atossa Therapeutics Inc (NASDAQ: ATOS)’s CEO, Steven Quay, will discuss and release Phase 2 trial final data of Endoxifen examined in breast cancer patients before surgery at a webinar on June 9, 2021. Other key executives to attend this webinar are its VP (Clinical, CMC, and Regulatory) – B. Heather Fraser, and CFO – Kyle Guse.
Atossa closed the mid-stage open-label clinical trial for oral administration of the drug in February 2021 after achieving positive results in a window opportunity in patients between surgery and breast cancer.
Conducts clinical trial of AT-301 nasal spray
Atossa is also continuing phase 1 clinical study of AT-301 nasal spray for at-home patients with COVID-19.
On February 25, 2021, Atossa released the final data from the phase 1 placebo-controlled, randomized, and double-blinded clinical trial of AT-301 nasal spray. The drug demonstrated improved tolerability and safety in healthy women and male subjects in this clinical trial over 14 days at two dose levels.
It now develops AT-301 for home treatment for patients diagnosed with coronavirus. No FDA-approved therapies for the treatment of coronavirus patients at home are available in the market.
AT-301 final data analysis does not indicate any serious side effects like bronchospasms and no discontinuations. Only mild symptoms like sneezing and nasal discomfort are noticed in subjects after single or two doses.
Quay is pleased with encouraging data of phase 1 clinical trial of AT-301 nasal spray. He said the company would soon commence the next phase of clinical assessment of AT-301.
Seeks FDA nod to conduct phase 2 clinical trial of AT-301
FDA recently released inputs on this program to Atossa for conducting additional pre-clinical studies. The company would seek the permission of the FDA to conduct a phase 2 clinical trial of AT-301 in the US.
Atossa targets to develop AT-301 nasal spray to prevent coronavirus infection in patients working in high-risk environments like people taking care of infected patients or people working in healthcare facilities, teachers, or emergency responders.
Atossa holds a cash balance, restricted cash, and cash equivalents of $137.7 million at the end of Q1 2021. Its R&D spending rose by 47% to $1.379 million because of the induction of new employees and trial expenses.