Bryn Pharma Secures $17.5M in Series D Funding to Advance FDA Fast Track-Designated Intranasal Epinephrine Device for Anaphylaxis

VCBeat (WeChat ID: vcbeat) has learned that on October 24, 2019, Bryn Pharma announced the completion of a $17.5 million financing round, marking the company’s fourth round of funding. Of this amount, $15 million came from existing and new investors, while $2.5 million was provided by corporate partners.

Bryn Pharma, established in 2017, is a private pharmaceutical company based in California, USA. The company is dedicated to finding better ways for patients and caregivers to manage acute allergic reactions.

It is estimated that 49 million people in the United States are at risk of anaphylaxis. Currently, epinephrine auto-injectors are the only option for protecting this high-risk population. Clinical evidence has demonstrated that such patients need to carry two epinephrine auto-injectors at all times, as up to 30% of individuals experiencing anaphylaxis require a second dose of epinephrine to control their symptoms.

However, studies have shown that due to considerations of product size and cost, most individuals at risk of anaphylaxis do not carry two epinephrine auto-injectors, thereby exposing them to a higher risk of severe complications during an anaphylactic episode.

The Bryn-NDS1C device is designed as a pocket-sized, portable unit capable of holding two doses of epinephrine, eliminating the need for patients to carry two separate emergency auto-injectors as previously required. It provides patients with a pocketable, easy-to-use therapeutic device that meets practical clinical parameters. This device can serve as an alternative to traditional epinephrine auto-injectors.

Over the past three years, the company has conducted multiple preclinical and clinical trials for Bryn-NDS1C. Earlier this year, the device received FDA Fast Track designation. In October 2019, Bryn Pharma completed pivotal human trials aimed at facilitating the successful market approval of this candidate product.

However, BRYN-NDS1C has not yet been approved for sale by the FDA or any international regulatory agency. This round of funding will be used to advance the approval and commercialization of BRYN-NDS1C.

Furthermore, Bryn Pharma has entered into an agreement with Aptar Pharma, a leading supplier of drug delivery systems, to utilize Aptar Pharma’s Bidose (BDS) nasal device for the administration of Bryn Pharma’s epinephrine nasal spray.

David Dworaczyk, CEO of Bryn Pharma, stated, “Our goal in establishing Bryn Pharma is to provide patients at risk of allergic reactions with an easy-to-use, needle-free, and portable product. The research and development as well as clinical trials for BRYN-NDS1C have been completed. Upon FDA approval, the remaining funds from this financing round will be allocated to commercialization efforts.”

(Compiled by Jiang Ying)