RALEIGH, N.C., June 10, 2020 /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 that a series of preclinical studies supporting the benefits of its BRYN-NDS1C needle-free device in the delivery of emergency epinephrine were recently published in three peer-reviewed scientific journals. The studies were included in the April 2020 editions of Respiratory Research and Pharmacology Research and Perspectives, and in the May 2020 edition of Pharmaceutical Research. The Company's patient-friendly, needle-free nasal delivery product candidate is designed to be easier to carry and use compared to auto-injectors which comprise the majority of the current emergency epinephrine market. The preclinical results described in the publications were used to support the advancement of BRYN-NDS1C into the human clinical trial program currently underway.
"The publication of our full preclinical program within such a concentrated timeframe is a significant accomplishment and highlights the importance of the work our team has undertaken to develop a more convenient therapeutic option for the treatment of severe anaphylaxis," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "These study findings suggest that intranasal epinephrine has the potential to become a new standard of care. We look forward to completing the remaining steps to develop and commercialize our epinephrine nasal spray as a patient-friendly alternative to auto-injectors."
Preclinical Program and Publications Results from a preclinical study evaluating the nasal delivery of epinephrine in a preclinical canine congestion model were published in the April 2020 edition of Respiratory Research. The preclinical results demonstrated that epinephrine administered nasally led to faster epinephrine absorption in the context of histamine-induced nasal congestion than in a control group without congestion. Because the release of histamine during an anaphylactic event often leads to congestion, the findings from this study are significant as they demonstrated that nasal congestion actually enhances the absorption of intranasal epinephrine. The article "Intranasal epinephrine effects on epinephrine pharmacokinetics and heart rate in a nasal congestion canine model" is available here.
The results of a second comparative pharmacokinetic (PK) study in a canine model were described in the April 2020 edition of Pharmacology Research and Perspectives in the article "Intranasal epinephrine in dogs: Pharmacokinetic and heart rate effects." Intranasal administration of epinephrine demonstrated a rapid increase in plasma epinephrine concentration when compared with intramuscular epinephrine administered via an auto-injector. Intranasal epinephrine showed reductions of increased heart rate over time, which were sustained after intramuscular epinephrine over the course of 90 minutes. There were no differences in safety measures after intranasal and intramuscular epinephrine. In the publication, the authors concluded that intranasal epinephrine demonstrated advantages over intramuscular epinephrine, including the rapid increase in plasma epinephrine and lack of increased heart rate over time. A copy of the publication is available here.
A third preclinical study of nasal epinephrine was described in the article "Effects of Intranasal Epinephrine on Cerebrospinal Fluid Epinephrine Pharmacokinetics, Nasal Mucosa, Plasma Epinephrine Pharmacokinetics, and Cardiovascular Changes" published in the May 2020 edition of Pharmaceutical Research. The canine model study was designed to determine if intranasal epinephrine crossed the blood-brain barrier. The results demonstrated that intranasal administration of epinephrine did not result in detection of epinephrine in the cerebral spinal fluid despite the increase in plasma levels at the same time point, indicating that intranasal administration of epinephrine did not result in epinephrine crossing the blood brain barrier. The authors concluded that "the use of epinephrine IN has potential to become the new standard of care in the treatment of severe allergy and anaphylaxis, which would contribute to the alleviation of patient or caregiver concerns with autoinjector use." A copy of the article is available here.
About the Clinical Development Program for BRYN-NDS1C 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, replacing the need to carry two epinephrine auto-injectors. In early 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BRYN-NDS1C. The human clinical trial program designed to support U.S. approval to market the product candidate is currently underway. In April 2020, results of the latest human clinical trial were presented at the American Academy of Asthma, Allergy and Immunology (AAAAI) Annual Meeting and demonstrated that intranasal (IN) delivery of epinephrine from the Company's needle-free, bi-dose device was comparable to intramuscular (IM) injection in pharmacokinetics, pharmacodynamics and safety. 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, founded in 2016, 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.