Atossa Therapeutics Announces Positive Interim Safety Assessment of First Group of Participants in Clinical Study of AT-301 ...
September 01 2020 - 9:30AM
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
a positive interim safety assessment from the first cohort of
healthy participants in the Phase 1 clinical study using Atossa’s
proprietary drug candidate AT-301 administered by nasal spray. This
first group of 8 participants received a single dose of either
AT-301A (placebo) or AT-301B (active drug). This blinded, positive
assessment by the safety committee allows the study to now enroll
the next cohort.
“This favorable safety review is an important milestone,”
commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.
“First in human studies typically have an early safety assessment
to ensure the drug is not harming participants and this positive
assessment allows us to continue enrolling patients, including at
higher doses and in repeated dose cohorts. We look forward to
completing this Phase 1 safety and tolerance study so that we can
begin to investigate the safety and efficacy of AT-301 in
preventing and/or mitigating a COVID-19 infection.”
The 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.
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, actions and inactions by the
FDA, the outcome or timing of regulatory approvals needed by Atossa
including those needed to commence studies of AT-H201, AT-301 and
Endoxifen, 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, whether
reduction in Ki-67 or any other result from a neoadjuvant study is
an approvable endpoint for oral Endoxifen, 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 IROffice:(516)
222-2560ir@atossainc.com
Source: Atossa Therapeutics, Inc.
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