Avance Clinical Client Atossa Therapeutics Announces Enrollment and Dosing Completed in First Group of Healthy Participants in Clinical Study of AT-301 Nasal Spray Being Developed for Treatment of COVID-19
August 27, 2020
The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that Atossa Therapeutics have enrolled and dosed the first cohort of healthy participants in the Phase 1 clinical study using its proprietary drug candidate AT-301, being administered by nasal spray.
Adelaide, Australia – The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that Atossa Therapeutics have enrolled and dosed the first cohort of healthy participants at CMAX Clinical Research in the Phase 1 clinical study using its proprietary drug candidate AT-301, being administered by nasal spray.
According to Atossa Therapeutics:
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a
clinical-stage biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need with a current
focus on breast cancer and COVID-19, today announced that it has enrolled and
dosed the first cohort of healthy participants in the Phase 1 clinical study
using its proprietary drug candidate AT-301, being administered by nasal spray.
This group of 8 participants received a single dose of either AT-301A (placebo)
or AT-301B (active).
“Advancing our COVID-19 drug candidates
through clinical studies as quickly as possible is our highest priority,”
commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.
“We are very encouraged by the high level of
interest in this study and the speed at which we enrolled this first group of
participants. 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. If this can slow virus proliferation sufficiently to
allow the patient to mount a strong, natural immune response AT-301 could
significantly impact the current public health options for controlling
COVID-19. We look forward to quickly completing enrollment of all cohorts in
this potentially important study.”
The study is a double-blinded, randomized,
and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult
subjects divided into two study groups. Part A consists of two single-dose
cohorts receiving either active therapy, AT-301B, or the placebo comparator
AT-301A at two different doses. Part B is a multiple dose arm with cohorts
receiving either AT-301A or AT-301B for 14 days at two different doses. The
primary objective of the study is to evaluate the safety and tolerability of
single and multiple doses of AT-301 administered via nasal instillation to
healthy volunteers. Secondary objectives are to assess the incidence and severity
of local irritation and bronchospasm following administration of AT-301 via
nasal instillation. The study is being conducted in Australia.
Avance Clinical Chief Scientific Officer Gabriel
Kremmidiotis PhD, BSC Hon said:
‘It is a privilege to have been selected by Atossa
Therapeutics to manage their AT-301 nasal spray for COVID-19 clinical trial.
This study is the latest addition to a number of studies that Avance Clinical has
been managing for Atossa Therapeutics over the past 5 years. Our relationship
with Atossa Therapeutics epitomises Avance Clinical’s service model
where our team become part of the client’s drug development team, executing
clinical development with the big picture in mind, assisting our clients
to achieve their goals across their whole product pipeline and not just
delivering transactional clinical trial management.’
Adelaide, Australia-based CMAX Clinical
Research is also part of the study and Jane Kelly, CEO at CMAX Clinical
Research said, “I am excited to be at the forefront with Avance Clinical
supporting Atossa Therapeutics develop a COVID treatment. South Australia was
able to move quickly through ethics and get our first participant dosed at a
ABOUT ATOSSA THERAPEUTICS
Atossa Therapeutics, Inc. is a clinical-stage
biopharmaceutical company seeking to discover and develop innovative medicines
in areas of significant unmet medical need with a current focus on breast
cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.
About Avance Clinical
Australia’s Avance Clinical has more than 20-years of experience and is now one
of Australia’s leading Contract Research Organizations. Avance Clinical
facilitates quality drug development by aligning people, skills, and expertise
in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research
services with its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually
grows through the careful selection of experts who also demonstrate passion in
their chosen field.
Avance Clinical offers high-quality services in an established clinical trial
ecosystem, that includes world-class Investigators and Sites able to access
specialized patient groups. Visit http://www.avancecro.com for more information.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including
hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical
Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies
year-round by taking advantage of Australia’s counter-flu and allergy seasons