Atossa Therapeutics Announces Second COVID-19 Therapeutic Development Program, AT-301 Nasal Spray: Summit Biosciences Retained to Develop and Supply AT-301 Nasal Spray for Clinical Study
Atossa Therapeutics (Nasdaq: ATOS) has initiated development of a second COVID-19 program using its proprietary nasal spray candidate, AT-301. This drug is designed for patients diagnosed with COVID-19 but not requiring hospitalization, aiming to reduce symptoms and slow infection rates. AT-301 targets essential human host proteases to inhibit SARS-CoV-2. The company plans to commence human clinical trials in Q3 2020, pending regulatory approvals. Summit Biosciences has been retained for product development. Provisional patent applications have been filed for AT-301.
- Initiation of AT-301 development may address unmet medical needs for non-hospitalized COVID-19 patients.
- Collaboration with Summit Biosciences for clinical supply strengthens development capabilities.
- Planned Q3 2020 start for human clinical trials suggests timely advancement in COVID-19 treatment.
- Regulatory approvals for clinical trials must still be obtained, posing potential delays.
- Dependence on trial results for safety and efficacy creates uncertainty around product viability.
- Competing in a crowded COVID-19 treatment market may dilute potential impact.
SEATTLE, May 28, 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 begun the development of a second COVID-19 program using its proprietary drug candidate AT-301, to be administered by nasal spray.
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, with the goal that it could become a “bridge to the vaccine” and be useful in the next phase of the coronavirus pandemic.
“In April we launched our AT-H201 COVID-19 HOPE program for the most severely ill COVID-19 patients,” commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. “By contrast, our new AT-301 nasal spray program is being developed for the relatively healthier COVID-19 patients who have not been hospitalized. We are developing AT-301 with a nasal spray delivery mechanism because many COVID-19 patients are infected via the nasal passage. The mechanism of action is intended to inhibit essential human host proteases, which are found in abundance in the nasal mucosa, from activating the SARS-CoV-2 Spike Protein, the known first and obligatory step that must be taken before the virus can enter the body.”
“This may eventually be useful as a prophylactic, to be used before leaving the home. In that setting it would be intended to create a barrier inside the nose to prevent virus entry - sort of a short-term vaccine-like treatment that could be helpful before a true vaccine is available. Our goal with the two COVID-19 programs is to ultimately commercialize therapies for patients on both ends of the spectrum – from the healthier patients who will be treated at home and the sicker patients who require mechanical ventilation in the hospital,” concluded Dr. Quay.
Atossa has retained Summit Biosciences, Inc., a pharmaceutical company with a proven track record in nasal spray medicines, to develop and produce a clinical supply of pre-filled nasal spray products in multi-dose devices containing AT-301 with the goal of commencing initial human clinical trials in the third quarter 2020.
Next steps with this program include the design and manufacturing of the clinical trial materials and the active pharmaceutical ingredients in AT-301 followed by adequate and well-controlled studies to demonstrate safety and efficacy. These studies 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 and intends to apply to the FDA as soon as possible so that human clinical trials may be commenced in the third quarter 2020.
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 Summit Biosciences
Founded in 2009, Summit Biosciences, Inc. of Lexington, KY (www.summitbiosciences.com) is a privately-held, specialized pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray medicines. It collaborates on the development of products with its clients and manufactures them at an industrial scale primarily for commercialization in the US and Europe.
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
kyle.guse@atossainc.com
Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@atossainc.com
Source: Atossa Therapeutics, Inc.
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