News: Avance Clinical Client Atossa Therapeutics Announces Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID
October 8, 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 client Atossa Therapeutics has announced a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 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 client Atossa Therapeutics has announced a
positive interim safety assessment from the second cohort of healthy
participants in the Phase 1 clinical study using Atossa’s proprietary drug
candidate AT-301 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, announced a positive interim safety assessment from the second cohort of healthy participants in the Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray.
This
second group of eight participants received a single escalated dose of either
AT-301A (placebo) or AT-301B (active drug). The blinded, positive assessment by
the safety committee allows the study to now enroll the next cohort, which will
be the third of a total of four cohorts and the first of two multi-dose,
placebo controlled cohorts.
“This
second favorable safety review marks an important milestone in this study as
half the participants have now been dosed and initial safety reviews have been
successfully completed,” commented Steven Quay, M.D., Ph.D., Atossa’s President
and CEO. “Based on rapid enrollment in the first half of the study, we expect
to complete enrollment in the remainder of the study very quickly. Recent data
from the CDC suggests that more than 90% of people testing positive for
COVID-19 do not require hospitalization. With this in mind, we are developing
our AT-301 nasal spray for home-use because there are no currently FDA-approved
treatments to help these patients with early disease to recover faster.”
Significant
advances have been made in the field of COVID-19 diagnostic testing. These
tests are now much more widely available and they can render results much more
quickly. Atossa plans to identify potential partners who are developing these
tests so that AT-301 nasal spray may be co-developed and commercialized with the
goal of making the AT-301 therapy available at the time a person tests positive
for the coronavirus. Atossa also plans to develop its nasal spray to
potentially help prevent COVID-19 infection, particularly for people in high
risk communities and those working in higher-risk areas, including healthcare
workers, emergency responders and teachers.
“We
anticipate that our AT-301 nasal spray will complement any traditional COVID-19
vaccine that may be developed,” added Dr. Quay. “A traditional COVID-19 vaccine
may be effective in in as few as half of the people taking it and recent
surveys indicate that as many as one-third of Americans may choose not to take
any COVID-19 vaccine once one becomes available. In addition, studies of
re-infection with the coronavirus suggest that the durability of immunity,
whether from an actual infection or a vaccine, may not be ideal. As a result,
therapies such as our nasal spray, similar to therapies working in tandem with
vaccines for seasonal flu, may form an important part of a broader response to
the coronavirus pandemic.”
The
ongoing Phase 1 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.’
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.
See full announcement: https://atossatherapeutics.com/atossa-therapeutics-receives-second-positive-interim-safety-assessment-in-clinical-study-of-at-301-nasal-spray-being-developed-for-the-coronavirus-causing-covid/
About Avance Clinical http://www.avancecro.com
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.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial
spend
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
sites
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