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
- 2021年03月12日 14:00:00
- テクノロジー
- JCN Newswire
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
Copyright 2021 JCN Newswire. All rights reserved. www.jcnnewswire.com
ドジャース山本由伸2回28球で降板 アクシデントか?
「タイタニック」英女優がディカプリオとの「船首キスシーン」振り返る
転売ヤーが湧く「未来のレモンサワー」が品薄で手に入らない!なんとか見つけたコンビニは……
礼儀正しい「ご飯待ちトリオ」の猫 完璧なフォーメーションに「芸術的」の声
在日コリアン芸人・マルセ太郎 没後23年、4世がたどったルーツ
米超大物夫妻が狭いエコノミー席で来日 乗り合わせた乗客のSNS投稿に世間も驚き
【森林環境税】を解説 今年度より創設され年額1000円 お得な納付方法も紹介
7勝目挙げた今永昇太が爆笑会見 ド派手ガッツポーズの心境は「もうおなかが減っていた」
がん治療中のキャサリン妃、半年ぶりに公の場に ルイ王子はダンス披露で今年も王子節さく裂
節税目的の相続税対策を実施する前に知っておくべき基礎知識 節税効果の低いものやトラブルでかえって損になることも
何があった!?「エアコン」が想定外の壊れ具合!投稿者に話を聞いた
玉置浩二の妻、青田典子(53)の現在がとんでもない事になっていると話題に
三上悠亜、整形したことを事後報告でネット騒然「素っぴんが美しすぎる」「大半を既にいじっておいて今更」
柏原崇(45)現在を調べてみた結果、相変わらずかっこよすぎた!
「愛が生まれた日」藤谷美和子(56)の現在がヤバい!?徘徊生活を送っていた過去も明らかに。
ユーチューバーもこう氏、元彼女・成海瑠奈について赤裸々告白
ガーシーが綾野剛のLINE公開でネット騒然「ショック」「すごいエンタメ」
オードリー若林結婚で嫁の名前がソッコーで特定する動き始まる
矢口真里、中学時代の写真公開「やっぱアイドルな人は、違うわ」ネット騒然
【ネタバレ?】史実で見るキングダムの今後の展開まとめ〜中華統一までの全体像
何があった!?「エアコン」が想定外の壊れ具合!投稿者に話を聞いた
玉置浩二の妻、青田典子(53)の現在がとんでもない事になっていると話題に
柏原崇(45)現在を調べてみた結果、相変わらずかっこよすぎた!
三上悠亜、整形したことを事後報告でネット騒然「素っぴんが美しすぎる」「大半を既にいじっておいて今更」
ユーチューバーもこう氏、元彼女・成海瑠奈について赤裸々告白
YouTuberジュキヤの動画企画が大炎上「普通に痴漢」「気持ち悪すぎ」
ガーシーが綾野剛のLINE公開でネット騒然「ショック」「すごいエンタメ」
「愛が生まれた日」藤谷美和子(56)の現在がヤバい!?徘徊生活を送っていた過去も明らかに。
オードリー若林結婚で嫁の名前がソッコーで特定する動き始まる
岡本夏生(56)、1600日ぶりにブログを更新した現在が衝撃
ドジャース山本由伸2回28球で降板 アクシデントか?
「タイタニック」英女優がディカプリオとの「船首キスシーン」振り返る
転売ヤーが湧く「未来のレモンサワー」が品薄で手に入らない!なんとか見つけたコンビニは……
礼儀正しい「ご飯待ちトリオ」の猫 完璧なフォーメーションに「芸術的」の声
在日コリアン芸人・マルセ太郎 没後23年、4世がたどったルーツ
米超大物夫妻が狭いエコノミー席で来日 乗り合わせた乗客のSNS投稿に世間も驚き
【森林環境税】を解説 今年度より創設され年額1000円 お得な納付方法も紹介
7勝目挙げた今永昇太が爆笑会見 ド派手ガッツポーズの心境は「もうおなかが減っていた」
がん治療中のキャサリン妃、半年ぶりに公の場に ルイ王子はダンス披露で今年も王子節さく裂
節税目的の相続税対策を実施する前に知っておくべき基礎知識 節税効果の低いものやトラブルでかえって損になることも