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Avance Clinical has been hired to oversee the clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, it has to be administered by nasal spray.
FREMONT, CA: The prominent Australian CRO for biotech and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner of Avance Clinical has been hired to oversee the clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, it has to be administered by nasal spray. Avance has effectively completed several clinical studies of Atossa's proprietary Endoxifen.
Atossa Therapeutics, Inc. is also a clinical-stage biopharmaceutical organization pursuing to uncover and develop pioneering medicines in fields of considerable unmet medical requirement. Its present focus is on breast cancer and COVID-19.
According to Yvonne Lungerhausen, CEO, Avance Clinical, "Avance Clinical is very pleased to be working with Atossa Therapeutics again on their second COVID-19 Therapeutic Development Program. Atossa is a valued long-term client that clearly understands the excellence in clinical research available in Australia, and the many benefits of conducting studies in the region."
Atossa Therapeutics commented: "AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2."
The study is a double-blinded, randomized, and placebo-controlled protection study of AT-301 nasal spray in 32 healthy adult subjects that are separated into two study groups. Part A contains two single-dose cohorts that receive either active therapy, AT-301B, or the placebo comparator AT-301A. Part B has a numerous dose arm that associates by receiving either AT-301A or AT-301B for 14 days. The main purpose of the study is to calculate the safety and acceptability of single and several doses of AT-301 administered through nasal installation to healthy volunteers. Secondary purposes are to evaluate the incidence and gravity of the local irritation and bronchospasm following the administration of AT-301 via nasal instillation.