RALEIGH – Bryn Pharma, which is developing a nasal spray to counteract life-threatening allergic reactions known as anaphylaxis, says it will move toward securing FDA approval for its product and plan to commercialize it after raising $17.5 million in new financing.
The company, which launched in 2016, announced the cash infusion two days after striking a deal to use a drug delivery system from Aptar Pharma. The Bidose (or two dose) device received FDA approval earlier this year.
Several founders and executives of Bryn suffer from extreme allergy risks, including reactions to bee stings and nuts.
Bryn wants to provide an alternative to current means beyond EpiPen (a pre-filled injection designed to quickly treat serious allergic reactions) for delivering epinephrine, which narrows blood vessels and opens airways in the lungs. “These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction,” says Drugs.com.
The new funding includes $15 million from current and new investors, which the firm did not identify.
Another $2.5 million came from an unamed “corporate collaborator.”
Bryn’s product is known as BRYN-NDS1C which includes a “bidose” of epinephrine. It has already been granted “fast track” status by the FDA. A “pivotal” clinical trial is now underway, the company says.
Aptar’s nasal device is designed for bidose delivery.
“We formed the Company with the singular goal of bringing an easy-to-use, needle-free, and convenient-to-carry solution to patients and their loved ones at risk of anaphylaxis,” said David Dworaczyk, CEO of Bryn Pharma, in the funding announcement.
“This financing follows our rapid advancement of the development and clinical testing of BRYN-NDS1C. The additional capital will be used to prepare for the rapid commercialization of the product once approved by the FDA.”
In the Aptar announcement, Dworaczyk noted: “We are excited to partner with Aptar Pharma to develop a product that can provide patients with a life-saving treatment that fits in a pocket, is easy to use and complies with practice parameters.”
The company notes that some 49 million Americans are “at risk” from anaphylaxis. Current auto-injectors must be carried by at-risk patients and a second injection is needed by as much as 30 percent of people affected, Bryn adds. It cited Annals of Allergy, Asthma & Immunology as the source for that information.
“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,” Bryn explained.