Bryn Pharma, a privately held Raleigh medical device company, is on track to soon provide people who have severe, possibly life-threatening allergies a needle-free option to treat anaphylaxis.

The U.S. Food and Drug Administration granted the Bryn Intranasal Epinephrine Spray (BRYN-NDS1C) Fast Track designation early in 2019. More recently, the company acquired $17.5 million in new financing. Current and new investors contributed $15 million while an unnamed “corporate collaborator” invested $2.5 million.

“We’re excited, motivated and passionate about what we’re doing,” CEO David Dworaczyk, Ph.D., told the North Carolina Biotechnology Center. Dworaczyk said the financing will help get BRYN-NDS1C into the hands of people who need it as soon as possible.

CEO David Dworaczyk, Ph.D. — Bryn Pharma photos

An industry ripe for disruption

An estimated 49 million Americans are at risk for anaphylaxis. Anaphylaxis is a severe overreaction of the body’s immune system to a foreign substance to which the body has become sensitized. It’s often caused by foods such as peanuts, insect stings, some medications and latex. It generally produces a sudden drop in blood pressure and narrowing of the airways, blocking breathing. Symptoms include a rapid, weak pulse; a skin rash; and nausea and vomiting.

Industry research indicates there are approximately 100,000 emergency department visits and an estimated 1,500 deaths attributed to anaphylaxis each year in the United States.

For 30 years, the standard of care has been for patients to carry two epinephrine auto-injectors with them at all times. The second auto-injector is recommended because up to 30 percent of people who have an anaphylactic reaction require a second dose to control symptoms.

Less than half of patients diagnosed with anaphylaxis carry one auto-injector. Less than 5% of those patients carry the recommended two auto-injectors because of size, cost and inconvenience. Some patients also admit to being afraid of giving themselves injections.

A mother’s intuition leads to innovation

Michelle Lobel, Bryn co-founder and chief inspiration officer, was aware of these obstacles as someone who suffers from severe nut allergies herself and as a mother with anaphylactic children. When she spoke to a doctor about treatment for her children, she was struck by the fact that it was exactly what she had been given as a child. She decided there must be a better way than epinephrine injections.

Michelle Lobel

Bryn was founded in 2016 to develop the Bryn Intranasal Epinephrine Spray as a needle-free, portable and easy-to-use solution for treating anaphylactic reactions. The device is small enough to fit into a pants pocket or a clutch purse. One device contains two doses of epinephrine. Neither a patient nor a caregiver will need to inject anything. Instead, they’ll simply spray the life-saving medication into the patient’s nose. Should a second dose be needed, it will be available from the same device – no need to carry two.

“We believe our product is less intimidating and much easier to use than epinephrine auto-injectors,” said Dworaczyk. “We see it being very disruptive and beneficial for millions of patients.”

(C) N.C. Biotech Center