Bryn Pharma Announces First Participant Dosed in PK/PD Trial with Upgraded Nasal Spray Device, Including First-of-Its-Kind, Two-Doses-in-One Nasal Spray Profile

New clinical trial data with Bryn Pharma’s second-generation epinephrine nasal spray expected in Q3 2025
The trial employs an upgraded two-spray nasal spray device providing additional reliability and user experience enhancements
Trial includes evaluation of pharmacokinetics (“PK”) and pharmacodynamics (“PD”) for an innovative two-doses-in-one device (“dual-dose”) product profile

LEBANON, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Bryn Pharma, Inc., (“Bryn”) a privately held pharmaceutical company dedicated to finding novel and convenient ways for patients and caregivers to treat anaphylaxis, today announced that it has dosed the first participant in a clinical trial of its second-generation, needle-free nasal epinephrine spray. A key goal of the study is to evaluate an upgraded version of the two-spray nasal spray device, which incorporates several enhancements over previous versions. As part of the trial, Bryn will also evaluate an innovative two-doses-in-one device ("dual-dose") product profile in which each spray from the device provides a full therapeutic dose, allowing for two complete doses from a single device. Current treatment options require access to two devices at all times due to the significant risk that one dose may not fully resolve symptoms. Bryn’s dual-dose profile could address a critical patient need by providing backup dosing within a single device. Data readout from the trial is expected in Q3 2025.

"Initiation of this trial marks a milestone for Bryn as we advance our epinephrine nasal spray program with significant enhancements to our nasal spray device, including further reliability enhancements, easier handling, improved comfort and fit, as well as an integrated dose indicator for clear user feedback,” said Joshua Ziel, Chief Executive Officer of Bryn Pharma. “This trial also provides the exciting opportunity to evaluate our innovative dual-dose profile, which has the potential to revolutionize anaphylaxis care by delivering two complete therapeutic doses in a single, lip-balm sized nasal spray.”

Trial Design and Objectives

Cohort 1 will evaluate the dual-dose profile. Participants will receive a single-spray dose from the nasal spray device for PK, PD, and safety and tolerability comparisons to injectable epinephrine standards of care.
Cohort 2 will evaluate a double-spray dose from the nasal spray device vs injectable epinephrine for PK, PD, and safety and tolerability comparisons.
The trial utilizes an upgraded version of the two-spray nasal spray device with enhanced features, including wider finger flanges for easier handling, a tapered nozzle to improve comfort and fit, an integrated dose indicator to provide users with clear feedback, as well as enhanced reliability for emergency-use applications.

Results from the trial will add to substantial clinical evidence for Bryn’s epinephrine nasal spray program, including completion of four pivotal clinical trials with the nasal spray platform and proprietary formulation. Bryn’s innovative approach to anaphylaxis treatment has been recognized by the U.S. Food and Drug Administration (FDA) with Fast Track designation, which is granted to facilitate the development and expedite the review of drugs that address unmet medical needs in serious conditions. This designation underscores the significant potential of Bryn's needle-free epinephrine delivery system to transform emergency anaphylaxis care for patients who face barriers with current injectable treatments.

About the Anaphylaxis Treatment Landscape

Anaphylaxis is a severe, life-threatening allergic reaction that requires immediate epinephrine treatment to prevent potentially catastrophic outcomes. The incidence of severe allergic reactions and anaphylaxis risk continues to rise dramatically across both children and adults yet the gold-standard treatment has remained largely unchanged since epinephrine autoinjectors were introduced in 1987. More than 50% of patients prescribed autoinjectors do not carry or use them as recommended due to needle phobia, accessibility issues, and portability challenges. The treatment landscape is further complicated by the fact that currently approved epinephrine products for anaphylaxis require immediate access to two full doses, forcing patients to carry 2 devices at all times. These challenges have created significant unmet need for truly portable, needle-free alternatives that help patients leave today’s injectable epinephrine standards of care behind.

About Bryn Pharma's Epinephrine Nasal Spray Program

Bryn Pharma’s epinephrine nasal spray program is designed to deliver patients at risk for anaphylaxis with an innovative, second-generation needle-free treatment option that addresses pent-up demand for portable, convenient and accessible epinephrine treatment. Comprised of Bryn’s proprietary epinephrine formulation combined with a unique two-spray nasal delivery system, each and every Bryn nasal spray device is designed to be able to achieve higher therapeutic epinephrine levels than today’s gold-standard, the 0.3 mg epinephrine autoinjector. Built on a proven active ingredient and device platform, the program benefits from the streamlined 505(b)(2) regulatory pathway in the United States and Bryn Pharma's exclusive device license for epinephrine applications across the United States, Canada, and other major pharmaceutical markets.

About Bryn Pharma

Bryn Pharma, Inc. (“Bryn”), established in 2017, is a privately held pharmaceutical company founded by patients, for patients. Bryn is focused on positively disrupting the existing market for epinephrine treatment by delivering patients at risk for anaphylaxis with accessible, needle-free, easy-to-use alternatives that better meet patient needs. For more information visit www.brynpharma.com.

Investor Contact:

LifeSci Advisors
Jeremy Feffer
JFeffer@LifeSciAdvisors.com

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