SEATTLE—Atossa Therapeutics Inc. recently reported blinded preliminary results from its Phase 1 clinical study for AT-301. The compound, administered by nasal spray, was found to be safe and well tolerated at two dose levels over 14 days. AT-301 is being developed for at-home use in patients recently diagnosed with COVID-19.
“We have completed all dosing in this study and we have now evaluated the blinded safety and tolerability data from all participants,” stated Dr. Steven Quay, president and CEO of Atossa. “There were no serious adverse events, no discontinuations and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity; all other adverse events were considered mild. These results support advancing this program into a Phase 2 study.”
The Phase 1 study of AT-301 nasal spray was divided into two groups. Part A consisted of two single-dose cohorts receiving either active therapy (AT-301B) or the placebo (AT-301A) at two different doses. Part B was a multiple-dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses. The study evaluated the safety and tolerability of single and multiple doses of AT-301 administered to healthy volunteers. Secondary objectives include assessing the incidence and severity of local irritation and bronchospasm.
“We believe AT-301 nasal spray is unique among the various therapies under development for COVID-19,” noted Quay in a press release about the company’s third quarter results. “While other companies are focused on therapies for patients being treated in hospitals, we are developing AT-301 for at-home use for the vast majority of COVID-19 patients who do not require hospitalization.”
“Although great progress has been made by companies developing vaccines, it has become clear that a vaccine won’t provide a complete solution to the pandemic. No vaccine will be 100-percent effective, and surveys have shown that many people won’t take a vaccine even when one becomes available,” he continued. “Similar to the seasonal flu where vaccines don’t provide complete community protection and people also rely on therapies, our AT-301 nasal spray therapy should form an important and necessary component of a comprehensive response to the COVID-19 pandemic.”
“We are developing AT-301 with a nasal spray delivery mechanism because many COVID-19 patients are infected via the nasal passage,” Quay explained on Atossa’s website. “The mechanism of action is intended to inhibit essential human host proteases—which are found in abundance in the nasal mucosa—from activating the SARS-CoV-2 spike protein, the known first and obligatory step that must be taken before the virus can enter the body.”
Atossa is on the lookout for potential partners who are developing COVID-19 diagnostic tests. The company hopes that AT-301 nasal spray could be co-developed and commercialized, with the goal of making AT-301 therapy available at the time a person tests positive for the coronavirus. Atossa also wants to develop the nasal spray to potentially help prevent COVID-19 infection, particularly for people in high-risk environments.
“[AT-301] may eventually be useful as a prophylactic, to be used before leaving the home,” the website noted. “In that setting, it would be intended to create a barrier inside the nose to prevent virus entry—sort of a short-term, vaccine-like treatment that could be helpful before a true vaccine is available.”
“We are very encouraged by these preliminary results. In the next 30 days, we plan to file a pre-IND meeting request with the FDA and, subject to their input, plan to immediately commence a Phase 2 study, either in the U.S. or abroad, in patients recently diagnosed with COVID-19,” Quay concluded.