Atossa Therapeutics Inc (NASDAQ:ATOS) reported positive results from the Phase 1 clinical trial of its innovative drug candidate AT-301. Currently, no FDA-approved treatments are available to treat coronavirus patients at home.
The patients are administered nasal spray – AT-301 in a placebo-controlled, randomized, and double-blinded clinical trial to test the efficacy, tolerability, and safety. Atossa achieved well tolerability and safety of its drug – AT-301 in Phase 1 14-day clinical study involving healthy females and males.
The data obtained from the phase 1 clinical trial involving 32 subjects indicates no discontinuations, no serious adverse events, and no bronchospasms. However, one subject suffered adverse events, which is considered moderate in severity. According to the assessment of Atossa, nasal spray AT-301 is well tolerated and safe.
CEO of Atossa, Steven Quay, said the clinical trial results are encouraging. Atossa will conduct the Phase 2 clinical trial of nasal spray soon. The company is preparing to conduct additional pre-clinical trials this quarter, considering the US FDA’s feedback.
Development of AT-301 to prevent coronavirus infection
AT-301 gears up to develop AT-301 into a full-pledged nasal spray to prevent COVID-19 infection, mainly for patients in high-risk areas like those who stay with an infected patient, teachers, emergency responders, and healthcare workers.
Administration of coronavirus across the world takes several months or years. AT-301 nasal spray plays a vital role during that time to save lives and prevent coronavirus infection. The US is reporting deadly variants of the coronavirus. Several nations across the world also report variants of coronavirus. Also, available coronavirus treatments in the market are not 100% effective. Also, older people, who take coronavirus vaccines, suffer from various side effects. Therefore, AT-301 is being developed to prevent the entry of the virus into the human body by inhibiting the activation of the obligatory spike protein.
To conduct a phase 2 clinical study, Atossa engaged Stockholm-based South General Hospital. The 6-month placebo-controlled, double-blinded, randomized phase clinical study is conducted to minimize the metabolic bone and parathyroid disorders in premenopausal women. Atossa awaits the ethics board’s nod and EMPA (European Medical Product Authority) to carry out the trial.