ENGLISH
|
JAPANESE
|
CONNECT WITH US:
Home
About
Contact
Log in
Home
Press release
Mar 12, 2021 12:00 JST
Source:
Avance Clinical
Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19
ADELAIDE, AUS, Mar 12, 2021 - (ACN Newswire) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) 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.
Yvonne Lungershausen, CEO, Avance Clinical said:
"As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical research."
According to Atossa Therapeutics:
Atossa Therapeutics today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa's proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.
Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild.
Atossa's assessment is that AT-301 nasal spray was safe and well tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.
"The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301," commented Steven Quay, M.D., Ph.D., Atossa's President and CEO.
Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world.
The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were 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 was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.
The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives were to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.
The study was being conducted in Australia.
See full announcement here.
https://tinyurl.com/6fchfvh2
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 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
Media Contact:
Chris Thompson
media@avancecro.com
Source: Avance Clinical
Sectors: Healthcare & Pharm
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
Latest Release
Fujitsu highlights technologies to realize its vision of AI as a trusted assistant at CEATEC 2024
Oct 04, 2024 11:03 JST
Toyota to Invest $500 Million in Joby Aviation
Oct 03, 2024 15:59 JST
Fujitsu and Supermicro announce strategic collaboration to develop green AI computing technology and liquid-cooled datacenter solutions
Oct 03, 2024 09:38 JST
Eisai Commences Business Activities At New Pharma Sales Subsidiary In Saudi Arabia
Oct 02, 2024 11:28 JST
IOWN All-Photonics Network with Optical Fiber Sensing Functions Achieves Wide-Area Traffic Flow Monitoring
Oct 01, 2024 17:44 JST
Release of Mazda Integrated Report 2024
Oct 01, 2024 10:56 JST
DENSO and ROHM Agree to Start Consideration of Strategic Partnership in the Semiconductor Field
Oct 01, 2024 09:27 JST
Olympus Launches VISERA S, a New Imaging Platform
Sep 30, 2024 15:00 JST
Fujitsu launches "Takane" - A large language model for enterprises offering the highest Japanese language proficiency in the world
Sep 30, 2024 14:05 JST
DENSO Announces Changes of Executive Responsibility and Executive Officers
Sep 30, 2024 13:22 JST
Mitsubishi Corporation: JOGMEC Commissioned Feasibility Study for Overseas CCS Value Chain
Sep 30, 2024 11:38 JST
Mazda Production and Sales Results for August 2024
Sep 27, 2024 17:20 JST
Honda Issues Integrated Report - "Honda Report 2024"
Sep 27, 2024 15:37 JST
Hitachi Becomes First Oracle Partner in Japan to Win Regional Best in Class Award in the Customer Success Category in the 2024 Oracle Partner Awards
Sep 27, 2024 14:19 JST
Mitsubishi Corporation Strengthens the Partnership with PETRONAS, Reinforcing Confidence in LNG Operations in the Region
Sep 27, 2024 13:39 JST
MHI Completes Production of the Core Stage of the Final H-IIA Launch Vehicle (No. 50)
Sep 26, 2024 12:00 JST
A2Z and Nayax Capital Sign Framework Agreements to Enable Global Financing for the Sale or Lease of Cust2Mate Smart Carts Integrated with Nayax's Solutions
Sep 25, 2024 22:00 JST
Osaka Gas and MHI to Implement the CO2NNEX Digital Platform for Managing and Transferring the Environmental Value of e-Methane at Expo 2025 Osaka, Kansai, Japan
Sep 25, 2024 15:11 JST
Hitachi Rail Unveils the 'HMAX' AI Solution, Accelerated by NVIDIA, to Optimize Trains, Signaling and Infrastructure
Sep 25, 2024 13:05 JST
Overview of Honda Exhibits at JAPAN MOBILITY SHOW BIZWEEK 2024
Sep 24, 2024 18:32 JST
More Latest Release >>
Related Release
Avance Clinical Appoints Asia Regional Director as Part of Global Expansion Program
July 23 2024 16:00 JST
New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Can Deliver 30% Savings, Halve Timelines and Cut Risks for Biotechs
June 04 2024 22:00 JST
Avance Clinical Expands Specialist CNS, Cardiometabolic, and Rare Diseases CRO Services in Europe with Julius Clinical
May 31 2024 16:00 JST
Avance Clinical Expands Further into APAC with New Clinical Operations in South Korea
May 08 2024 09:00 JST
Avance Clinical Showcases Clinical Excellence at World Orphan Drug Conference in Boston, April 23-25
April 19 2024 16:00 JST
Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study
March 28 2024 14:42 JST
Avance Clinical CEO Talks with SCRIP about US Biotech Sector "Green Shoots" and a New CRO Report
February 28 2024 08:00 JST
Latest Analysis Reveals 65% of US Biotechs Struggle to Identify Suitable CRO Partner
January 12 2024 16:00 JST
Avance Clinical Invited to Brief 45 Korean Biotechs on Their GlobalReady Drug Development Pathway from Korea and Australia to the US
October 19 2023 09:00 JST
Avance Clinical at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients
May 30 2023 10:00 JST
More Press release >>