ATOS Atossa Therapeutics Inc.

3.96
+0.13  (+3%)
Previous Close 3.83
Open 3.85
52 Week Low 0.755
52 Week High 5.08
Market Cap $36,465,494
Shares 9,208,458
Float 8,659,350
Enterprise Value $25,954,652
Volume 651,694
Av. Daily Volume 926,589
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Drug Pipeline

Drug Stage Notes
Endoxifen
Breast cancer - window of opportunity setting
Phase 2
Phase 2
Phase 2 interim data released May 7, 2020.
Endoxifen - oral
Mammographic breast density (MBD)
Phase 2
Phase 2
Phase 2 initiation of enrolment has been delayed due to COVID-19.
Endoxifen
Male breast cancer and Gynecomastia
Phase 1
Phase 1
Phase 1 preliminary data September 13, 2018 noted drug met safety and tolerability objectives. Final data January 9, 2019 confirmed objectives met. Program will not be advanced in 2020.
Fulvestrant
Cuctal carcinoma in situ(DCIS) - invasive breast cancer
Phase 2
Phase 2
Phase 2 trial ongoing - noted December 28, 2017.
Endoxifen
Mammographic breast density (MBD)
Phase 2
Phase 2
Phase 2 data met primary endpoint - June 27, 2019. High dropout rate noted.

Latest News

  1. SEATTLE, Aug. 03, 2020 (GLOBE NEWSWIRE) -- 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 received approval from the ethics committee to open a Phase 1 clinical study in Australia using Atossa's proprietary drug candidate AT-301, to be administered by nasal spray. All necessary approvals have now been obtained and enrollment is expected to begin in the next 30 days.

    "The most common entry point for the coronavirus is the nasal passage where the virus can infect locally for one to three days before progressing into the lungs," commented…

    SEATTLE, Aug. 03, 2020 (GLOBE NEWSWIRE) -- 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 received approval from the ethics committee to open a Phase 1 clinical study in Australia using Atossa's proprietary drug candidate AT-301, to be administered by nasal spray. All necessary approvals have now been obtained and enrollment is expected to begin in the next 30 days.

    "The most common entry point for the coronavirus is the nasal passage where the virus can infect locally for one to three days before progressing into the lungs," commented Steven Quay, M.D., Ph.D., Atossa's President and CEO. "Our nasal spray drug is being developed with a ‘vaccine-like mechanism' to help maintain a 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 growth sufficiently to allow the patient to mount a strong, natural immune response AT-301 could be very impactful on the current public health options for controlling COVID-19. We look forward to quickly opening enrollment in this important study and reporting results before the end of the year."

    AT-301 is being developed for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2; for example, as a daily preventative treatment for people at higher-risk, such as frontline workers, military, emergency medical professionals, and hospital personnel.

    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.

    "Over the years, the U.S. Food and Drug Administration has accepted well-controlled, high quality studies conducted outside the U.S. and our existing relationship with the contract research organization conducting our AT-301 trial, and their history of success with our other Phase 1 trials, expedited our ability to get the drug in the clinic, which in the case of COVID-19 is of paramount importance. Assuming a favorable outcome, we anticipate the results of this trial to be readily included in future applications with the FDA. Seeking approval in Australia, where unfortunately COVID-19 cases are rising again, is also an option," added Dr. Quay.

    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.

    FORWARD-LOOKING STATEMENTS

    Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, whether in vitro test results will also be achieved in in vivo studies, including human clinical studies, actions by and interactions with the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence human clinical studies of AT-301, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse, CFO and General Counsel

    Office: 866 893-4927

    Investor Relations Contact:

    Core IR

    Office:(516) 222-2560



    Source: Atossa Therapeutics, Inc.

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  2. SEATTLE, July 30, 2020 (GLOBE NEWSWIRE) -- 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, announces interim findings following 18 months of an Expanded Access (or "compassionate use") single-patient study of Atossa's Endoxifen. To date, the patient has not had a recurrence of breast cancer, as assessed by clinical breast examination and mammography; has not had treatment-related changes in periodic laboratory blood tests and general clinical examinations; and the treatment has been well tolerated, including an absence of typically seen vasomotor symptoms (for…

    SEATTLE, July 30, 2020 (GLOBE NEWSWIRE) -- 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, announces interim findings following 18 months of an Expanded Access (or "compassionate use") single-patient study of Atossa's Endoxifen. To date, the patient has not had a recurrence of breast cancer, as assessed by clinical breast examination and mammography; has not had treatment-related changes in periodic laboratory blood tests and general clinical examinations; and the treatment has been well tolerated, including an absence of typically seen vasomotor symptoms (for example, night sweats and hot flashes).

    The study results show that treatment with Atossa's proprietary Endoxifen for 20 days prior to unilateral mastectomy and for 18 months after surgery as an adjuvant did not lead to vasomotor symptoms commonly associated with tamoxifen, an FDA-approved drug frequently prescribed for breast cancer treatment. Endoxifen did not cause other safety and tolerability concerns in this patient. The percentage of cells expressing ER+ or Ki-67 decreased from the initial biopsy to the biopsy on the day of surgery (a 50% reduction in the case of Ki-67 and a 22% decrease in ER+ cells); plasma Endoxifen reached the potential therapeutic level (≥ 35 nM) by day 6; and steady state Endoxifen was maintained through day 20 prior to surgery. Atossa plans to publish a manuscript of the case study.

    "Pre-menopausal breast cancer patients have very limited treatment options," commented Steve Quay, Ph.D., M.D., Atossa's President and CEO. "They are often reluctant to take tamoxifen because most patients experience hot flashes and night sweats. Moreover, many patients, including the patient here, lack the proper liver enzymes to metabolize tamoxifen so they may not receive a therapeutic benefit. We look forward to continuing enrollment in our Phase 2 study in this ‘window of opportunity' setting and to continuing to follow this patient's progress."

    At the end of 2018, the FDA authorized a single-patient study under its Expanded Access, or compassionate use program, for this breast cancer patient to receive Atossa's oral Endoxifen in the "window of opportunity" between diagnosis of breast cancer and surgery. Following surgery, an additional compassionate use authorization was granted by the FDA for the same patient, who has now continued to take oral Endoxifen for approximately 18 months in the adjuvant setting following her surgery. She will continue to take oral Endoxifen daily under this authorization.

    Atossa's Ongoing Phase 2 Window of Opportunity Study of Endoxifen

    In addition to the compassionate use patient, Atossa is conducting a Phase 2 study of its oral Endoxifen in the window of opportunity between diagnosis of breast cancer and surgery. The study will enroll up to 25 newly-diagnosed patients with ER+ and human epidermal growth factor receptor 2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients receive Atossa's proprietary oral Endoxifen for at least 14 days from the time of diagnosis up to the day of surgery. The primary endpoint is reduction of tumor activity as measured by Ki-67. The secondary endpoints are safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors. The impact on additional markers of cellular activity will also be explored. The Phase 2 study is being conducted on behalf of Atossa by Avance Clinical, which successfully completed four Phase 1 studies of Atossa's Endoxifen.

    The open-label study is designed to permit an interim analysis of the Ki-67 change. The requirement to proceed with the study was to achieve a meaningful Ki-67 change in at least two of eight patients. Impressively, all patients in the interim group (N=6) have experienced a significant reduction in Ki-67. As previously announced, a summary of these results includes:

    • Ki-67 was reduced by more than 50% in every patient in the window of opportunity between initial biopsy and surgery, with an overall reduction of 74%.
    • All six patients had a Ki-67 below 25% after treatment. A meta-analysis of 64,196 patients found that Ki-67 was an independent prognostic value for predicting overall survival in ER+ breast cancer patients (Petrelli, F., Viale, G., Cabiddu, M. et al. Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients. Breast Cancer Res Treat 153, 477–491 (2015) https://doi.org/10.1007/s10549-015-3559-0). Ki-67 levels below 25% were associated with the lowest risk of death in this systematic review and meta-analysis.
    • Treatment ranged from 16-40 days with an average of 22 days.
    • There were no safety or tolerability issues, including vasomotor symptoms such as hot flashes and night sweats, which are often a tolerability challenge for patients on tamoxifen.

    Based on interim results from the window of opportunity study and the results from the compassionate use patient, Atossa is evaluating a number of potential clinical benefits and potential indications for its oral Endoxifen in the window of opportunity setting. These may include avoidance of surgery in some patients, such as older and/or frail patients, allowing for breast conservation surgery, and use of Endoxifen in place of other neoadjuvant therapies such as chemotherapy, aromatase inhibitors and other endocrine therapies like tamoxifen.

    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.

    Forward-Looking Statements

    Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, whether in vitro test results will also be achieved in in vivo studies, including human clinical studies, actions by and interactions with the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence human clinical studies of COVID-19 therapies, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse, CFO and General Counsel

    Office: 866 893-4927

    Investor Relations Contact:

    Core IR

    Office:(516) 222-2560

    Source: Atossa Therapeutics, Inc.

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  3. SEATTLE, July 27, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company with a current focus on breast cancer and COVID-19, announces that Atossa's CEO, Dr. Steven Quay, M.D., Ph.D., will present at Tribe Public's Zoom Webinar Presentation and Q&A Event that is scheduled to begin at 8am pacific/11am eastern on Thursday, July 30th.  During this complimentary, 30-minute event, Dr. Quay will present the company followed by a Q&A session regarding Atossa's breast cancer development programs and recent progress with its two COVID-19 treatment programs. To register to join the complimentary event, please visit the Tribe Public LLC website: www.tribepublic.com, or send a message to Tribe's management…

    SEATTLE, July 27, 2020 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company with a current focus on breast cancer and COVID-19, announces that Atossa's CEO, Dr. Steven Quay, M.D., Ph.D., will present at Tribe Public's Zoom Webinar Presentation and Q&A Event that is scheduled to begin at 8am pacific/11am eastern on Thursday, July 30th.  During this complimentary, 30-minute event, Dr. Quay will present the company followed by a Q&A session regarding Atossa's breast cancer development programs and recent progress with its two COVID-19 treatment programs. To register to join the complimentary event, please visit the Tribe Public LLC website: www.tribepublic.com, or send a message to Tribe's management at to request your seat for this limited capacity Zoom-based event.

    Steven Quay, M.D., Ph.D. is the founder of Seattle-based Atossa Therapeutics, Inc. (NASDAQ:ATOS). He received his M.D. and Ph.D. from The University of Michigan, was a postdoctoral fellow in the Chemistry Department at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-MGH Hospital and spent almost a decade on the faculty of Stanford University's School of Medicine. His contributions to medicine have been cited 9,890 times. He has founded six startups, invented seven FDA-approved pharmaceuticals, and holds 87 US patents. Over 80 million people have benefited from the medicines he invented. His current passions are solving big medical problems: stopping the COVID-19 pandemic and preventing the two million breast cancers in the world each year. Dr. Quay's recently-published and highly acclaimed book titled "COVID-19 Survival Manual: A Physician's Guide to Keep You and Your Family Healthy During the Pandemic and Beyond" is available at his website: www.drquay.com.  

    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 TRIBE PUBLIC LLC 

    Tribe Public LLC is a San Francisco, CA based organization that hosts complimentary worldwide webinar & meeting events in the U.S. Tribe's complimentary events focus on issues that the Tribe members care about with an emphasis on hosting management teams from publicly traded companies from all sectors & financial organizations that are seeking to increase awareness of their products, progress and plans. Tribe members primarily include Family Offices, Portfolio Managers, Registered Investment Advisors, & Accredited Investors. Website: http://www.tribepublic.com/.             

    FORWARD-LOOKING STATEMENTS 

    Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with the following: whether in vitro test results will also be achieved in in vivo studies, including human clinical studies, actions by and interactions with the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence human clinical studies of AT-301 and the outcome of such trials, lower than anticipated rate of patient enrollment, the safety and efficacy of Atossa's product candidates, performance of developers and manufacturers, clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, uncertainties affecting our ability to secure patent protection for AT-301 or AT-H201 and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time. 

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse, CFO and General Counsel

    Office: (866) 893-4927

     

    Investor Relations Contact:

    Core IR

    Office: (516) 222-2560



    Source: Atossa Therapeutics, Inc.

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  4. Adelaide, AUS, July 22, 2020 - (ACN Newswire) - The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been contracted to conduct a clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, to be administered by nasal spray. Avance has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.



    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 Lungerhausen, CEO, Avance Clinical said:

    "Avance Clinical is very pleased to be working with Atossa…


    Adelaide, AUS, July 22, 2020 - (ACN Newswire) - The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been contracted to conduct a clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, to be administered by nasal spray. Avance has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.



    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 Lungerhausen, CEO, Avance Clinical said:

    "Avance Clinical is very pleased to be working with Atossa Therapeutics again on their second COVID-19 Therapeutic Development Program. Atossa is a valued long-term client that clearly understands the excellence in clinical research available in Australia, and the many benefits of conducting studies in the region."

    According to Atossa Therapeutics:

    AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2.

    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. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. 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.

    "Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators," commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. "Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a 'vaccine-like mechanism' to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel," concluded Dr. Quay.

    An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter. Adequate and well-controlled studies to demonstrate safety and efficacy must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.

    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 here https://tinyurl.com/y46rcp33

    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

    Source: Avance Clinical

    Copyright 2020 ACN Newswire . All rights reserved.

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  5. SEATTLE, July 16, 2020 (GLOBE NEWSWIRE) -- 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 that it has contracted with Avance Clinical Pty Ltd to conduct a clinical study of Atossa's proprietary drug candidate AT-301, to be administered by nasal spray. Avance is a leading Australian clinical research organization and has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.

    AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet…

    SEATTLE, July 16, 2020 (GLOBE NEWSWIRE) -- 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 that it has contracted with Avance Clinical Pty Ltd to conduct a clinical study of Atossa's proprietary drug candidate AT-301, to be administered by nasal spray. Avance is a leading Australian clinical research organization and has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.

    AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2.

    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. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. 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.



    "Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators," commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. "Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a ‘vaccine-like mechanism' to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel," concluded Dr. Quay.



    An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter.



    Adequate and well-controlled studies to demonstrate safety and efficacy must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.



    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 PTY LTD



    Avance Clinical Pty Ltd is a leading Australian CRO with a client portfolio that extends across North America, Canada, New Zealand, Asia and Europe. Avance Clinical is an Australian owned CRO that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. Its office is located in Adelaide, South Australia with employees operating across the major Australian states and New Zealand.



    Avance Clinical specializes in working with biotech companies to execute Phase 1 and Phase 2 clinical trials. It is a full service CRO with services including clinical project management, clinical trial monitoring, drug safety reporting, medical writing, data management, statistical and pharmacokinetic services, and external auditing.



    FORWARD-LOOKING STATEMENTS

    Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with the following: whether in vitro test results will also be achieved in in vivo studies, including human clinical studies, actions by and interactions with the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence human clinical studies of AT-301 and the outcome of such trials, lower than anticipated rate of patient enrollment, the safety and efficacy of Atossa's product candidates, performance of developers and manufacturers, clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, uncertainties affecting our ability to secure patent protection for AT-301 or AT-H201 and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.



    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse, CFO and General Counsel

    Office: (866) 893-4927





    Investor Relations Contact:

    Core IR

    Office: (516) 222-2560





    Source: Atossa Therapeutics, Inc.

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