RALEIGH, N.C., Feb. 27, 2021 /PRNewswire/ -- Bryn Pharma,
LLC ("Bryn" or the "Company"), a privately held pharmaceutical
company dedicated to finding a better way for patients and
caregivers to treat anaphylaxis, today announced positive
clinical results from its multi-dose study of BRYN-NDS1C (bi-dose
epinephrine nasal spray). Results from the study demonstrated that
administration of epinephrine with one spray/dosing from Bryn's
two-dose nasal spray device resulted in a favorable release profile
with both short- and long-term pharmacokinetic (PK) outcomes that
were comparable to or greater than those seen with administration
by a single 0.3 mg epinephrine auto-injector. No safety issues were
seen and there were no serious or unexpected adverse events with
either intranasal (IN) or intramuscular (IM) dosing.
Full results from the late-breaking poster were presented today
at the 2021 American Academy of Allergy, Asthma and Immunology
(AAAAI) virtual annual meeting. The study abstract is
published in the February 2021 online
supplement to The Journal of Allergy and Clinical
Immunology, and the poster presentation is available
online.
"These clinical results show that a single spray from our
bi-dose nasal spray device delivered epinephrine at levels equaling
or exceeding those administered with a single 0.3 mg epinephrine
auto-injector, potentially allowing patients to replace two
auto-injectors with a single nasal device," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "Up
to 30% of patients experiencing an anaphylactic event require a
second dose of epinephrine, and our bi-dose nasal spray device
meets this critical need along with other advantages including
needle-free delivery, ease of use and portability. We will continue
to work diligently to complete the required steps remaining to gain
FDA approval."
About the Study
The open-label, randomized, 5-treatment, 5-way crossover study
compared the pharmacokinetics of intranasal (IN) and intramuscular
(IM) epinephrine administration in 25 healthy adults 19-45 years of
age. Epinephrine administrations were as follows: 6.6 mg IN (1 x
6.6 mg), 4.4 mg IN (2 x 2.2 mg), 8.8 mg IN (2 x 4.4 mg), 13.2 mg IN
(2 x 6.6 mg), and 0.3 mg IM (1 x 0.3 mg). Epinephrine
concentrations and cardiovascular effects were measured (-30-360
minutes). PK parameters (AUC0-10, AUC0-20,
AUC0-30, AUC0-60, AUC0-360,
Cmax(10 min), Cmax; ANOVA analysis) and
safety were assessed. Epinephrine bioavailability and cumulative PK
data showed that the single 6.6 mg IN epinephrine was comparable to
or greater than 0.3 mg IM epinephrine auto-injector, with similar
epinephrine related pharmacodynamic effects. Other key results of
the study were as follows:
- At most time points, a comparable percentage of participants
reached epinephrine plasma concentrations of 100 and 200 pg/mL at
key time point intervals after administration of Bryn's IN as
compared to IM administration.
- There were no clinically significant differences in heart rate
or blood pressure after administration of epinephrine IN or IM
Researchers in the study concluded that Bryn's bi-dose nasal
spray is a novel therapeutic option in anaphylaxis treatment which
allows patients to administer a second dose readily if the first
dose does not abate symptoms.
BRYN-NDS1C Bi-Dose Epinephrine Nasal Spray
Bryn Pharma's Bi-dose Epinephrine Nasal Spray (BRYN-NDS1C) is a
single, portable, needle-free device capable of delivering two
therapeutic doses of epinephrine, ensuring compliance with clinical
guidance while replacing the need to carry two epinephrine
auto-injectors. The two therapeutic doses contained in each bi-dose
IN device provides assurance that a second dose is readily
available if another dose is needed for symptom control, a critical
need that occurs in 30% of patients experiencing an anaphylactic
event. In early 2019, the U.S. Food and Drug Administration (FDA)
granted Fast Track Designation to BRYN-NDS1C. The Company has
completed three human clinical studies of BRYN-NDS1C and has put in
place a commercial-scale, high-speed manufacturing line in
preparation for the anticipated market launch. BRYN-NDS1C is not
currently approved for sale by the FDA or any international
regulatory authority.
About Anaphylaxis
Anaphylaxis is a serious, life-threatening allergic reaction.
The most common anaphylactic reactions are to foods, insect stings,
medication and latex.1 A major difference between
anaphylaxis and other allergic reactions is that anaphylaxis
typically involves more than one system of the body.2
Anaphylaxis requires immediate medical treatment, driving
approximately 100,000 emergency room visits in the U.S. each
year.1,3 Because 30% of patients who develop anaphylaxis
will require a second dose of epinephrine to control symptoms,
practice parameters recommend that physicians provide patients with
two auto-injectors.4 If not treated properly,
anaphylaxis can be fatal.2 However, studies have shown
that the majority of people at risk for anaphylaxis often do not
carry two epinephrine auto-injectors due in part to size and cost
of the products, putting patients at greater risk of severe
complications during an allergic reaction.
About Bryn Pharma
Bryn Pharma is a privately held pharmaceutical company founded
by patients for patients. Bryn is focused on positively disrupting
the existing market for epinephrine auto-injectors by delivering an
accessible, easy-to-use alternative that better meets the needs of
patients. Bryn Pharma seeks to provide this growing population at
risk for anaphylaxis with A Better Way to be prepared for a
life-threatening allergic reaction. For more information visit
www.brynpharma.com.
Forward Looking Statements
Statements made in this press release that look forward in time
or that express beliefs, expectations or hopes regarding future
occurrences or anticipated outcomes or benefits are forward-looking
statements. A number of risks and uncertainties, such as risks
related to product development and commercialization efforts,
results of clinical trials, ultimate clinical outcomes and benefit
of the Company's products to patients, market and physician
acceptance of the Company's products, intellectual property
protection and competitive product offerings, could cause actual
events to differ from the expectations indicated in these
forward-looking statements. You are cautioned not to put any undue
reliance on any forward-looking statement. This press release is
neither an offer to sell nor a solicitation of an offer to purchase
any particular securities. Any such offer or solicitation will be
made only pursuant to definitive legal agreements prepared
specifically for such purpose. An investment in the Company's
securities entails significant risks and is suitable only for
sophisticated investors who can afford a loss of their entire
investment; no assurance can be given that investment objectives
will be achieved. In considering the performance information
contained herein, you should bear in mind that past performance is
not necessarily indicative of future results; there can be no
assurance that the Company will achieve comparable results or that
any projected returns will be met. The Company does not assume any
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise.
-
American Academy of Allergy, Asthma & Immunology. Available at https://www.aaaai.org/conditions-and-treatments/allergies/anaphylaxis.
Accessed on December 21, 2020.
-
American Academy of Allergy, Asthma & Immunology. Available at: https://www.aaaai.org/conditions-and-treatments/conditions-dictionary/anaphylaxis.
Accessed on December 21, 2020.
-
Fromer L. Prevention of Anaphylaxis: The Role of the Epinephrine Auto-Injector. Am J Med. 2016 Dec; 129(12):
1244-1250.
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Anaphylaxis –a practice parameter update 2015; Lieberman, Phillip et al.; Annals of Allergy, Asthma &
Immunology, Volume 115, Issue 5, 341-384
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