Client News: Avance Clinical Client Atossa Therapeutics Completes Enrollment of Phase 1 Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID
November 3, 2020
Avance Clinical is pleased to share the news that their client Atossa Therapeutics (NASDAQ: ATOS) has announced completion of enrollment in its Phase 1 clinical study.
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 their client Atossa Therapeutics (NASDAQ: ATOS) has
announced completion of enrollment in its Phase 1 clinical study using Atossa’s
proprietary drug candidate AT-301 administered by nasal spray for the treatment
of COVID-19. AT-301 is being developed for at home use enabling management of
the infection symptoms with at home quarantine and potentially preventing
disease progression.
Avance Clinical Chief Scientific Officer Gabriel
Kremmidiotis PhD, BSC Hon said:
“With a number of countries around the
globe currently experiencing secondary waves of COVID-19 infection spread, the
need for vaccines and therapies is significant and the ability to deliver fast
start-up and execution of clinical trials to expedite development of such products,
like AT-301, is essential. Avance was able to deliver start-up and execution of
the AT-301 trial in record time. We have a very experienced team who worked
effectively with Australian Human Research Ethics and a dedicated Phase I unit
based here in South Australia in delivering this great result for Atossa.”
According to Atossa Therapeutics:
Atossa Therapeutics, Inc., 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 it has now completed enrollment
in its Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301
administered by nasal spray.
“Completing enrollment is a significant
milestone and comes at a time when we are seeing a new wave if infections in
certain geographies and an increased focus on developing therapies to treat
COVID-19,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.
“While the virus presents significant danger overall, the vast majority of
people testing positive for COVID-19 do not require hospitalization and instead
quarantine at home while they manage their symptoms and attempt not to infect
those around them. As there are no currently FDA-approved treatments to help
these patients, we are developing AT-301 for at home use so that they can
recover faster.”
Atossa plans to identify potential
partners who are developing COVID-19 diagnostic 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 environments —
including, for example, people living with a patient infected with COVID-19,
healthcare workers, emergency responders and teachers. In addition to seeking a
partner, Atossa’s next steps with this program include contracting for a
commercial supply of the nasal spray devices; reporting preliminary top line
results from the Phase 1 study; and completing regulatory filings and any
necessary approvals to launch a Phase 2 study, which it is planning for the
first half of 2021.
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.
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 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