When the COVID-19 pandemic first emerged, no one, not even the pharmaceutical industry, was prepared. The world got into a panic mode due to the rapid spread of the coronavirus. Hundreds of pharmaceutical companies put aside their major activities to focus on vaccines for the virus. Atossa Therapeutics Inc (NASDAQ:ATOS), which develops innovative medicines for breast cancer, was one.
The company has been developing a nasal spray for COVID-19. The proprietary drug candidate AT-301 is in the Phase 1 clinical study. Eight participants who make up the first cohort have received a single dose of either placebo or active drug, and positive interim safety assessment has been reported.
The Safety Review is a Platform for Enlarging the Phase 1 clinical study
The favorable review from the eight participants is a step forward, according to Atossa’s CEO, Steven Quay. Besides, it is the first in human studies, and so far, no adverse events have been reported. This allows the company to expand the study with more adult subjects, which Quay says will be in two parts. Part A will receive two single-dose cohorts of active therapy, while part B will receive multiple dose arm with cohorts. This will engage 32 participants for 14 days.
The study, which has gained high levels of interest, is being carried out in Australia. The primary objective is to assess the safety and tolerability of single and multiple doses. The secondary objective is to evaluate and gauge incidences and brutality of local irritation and bronchospasm.
‘’…Our novel nasal spray drug candidate is being developed to provide a unique protective mucosal barrier with anti-viral properties within the nasal cavity, hopefully leading to lower infectivity and reduced symptoms in COVID-19 patients’’… Quay announced.
Atossa’s COVID-19 Programs
Earlier in the year, the company launched COVID-19 HOPE (AT-H201), a program to develop a therapy for improving lung function. This would eventually reduce the amount of time COVID-19 patients spend on ventilators.
The number of patients needing mechanical ventilation is increasing by the day. This is deeply worrisome because some of them may never regain their lung function. Besides, many hospitals are running short of ventilators, yet a vaccine could take longer than a year to develop.