Asheville’s Olfax Medical seeking to launch new migraine treatment
An Asheville specialty pharmaceutical company is working to transform a century-old medical procedure into a treatment for migraine relief that patients can easily perform at home.
Olfax Medical has developed a nasally administered drug delivery technology, potentially allowing patients to treat themselves easily anytime, wherever they are. The company is using its device to create novel therapeutics for a range of central nervous system disorders beyond migraine.
Olfax expects to enter its migraine treatment program, Relaspen, into clinical trials in 2025.
Since its founding in 2018, Olfax has secured an increasing level of funding through grants and awards, boosted in 2022 with awards totaling $35,000 as a regional and top-three statewide winner in the NC BIONEER Venture Challenge, now called the NCBiotech Venture Challenge, from the North Carolina Biotechnology Center.
“Olfax’s initial inspiration was how we could take this highly effective headache treatment, which offers rapid, non-opioid pain relief, out of the clinic and put it in the hands of patients,” said Jonathan Beckwith, Olfax CEO. “Since then, we’ve continued to evolve our product and company strategy while receiving tremendous support from local, state, and federal programs.”
Stair-Step Approach
The path from idea to product development to clinical trials and a planned investigational new drug (IND) application with the U.S. Food and Drug Administration has been steady and deliberate. Beckwith describes it as a stair-step approach.
Starting with introductions to the local entrepreneurial community in Asheville in 2018, Olfax has applied for and secured at least six separate rounds of funding, mostly through grants and awards. The funding has come with in-kind services, advice and other non-monetary benefits, each building on earlier steps to help secure bigger awards. The funding includes:
● 2019: $5,000 micro-grant from Venture Asheville
● 2021: $54,000 grant from the DRIVEN Accelerator Hub of the National Institutes of Health
● 2022: $35,000 NCBiotech NC BIONEER Venture Challenge award (two rounds – regional and statewide awards)
● 2022: $337,000 Phase 1 Small Business Innovation Research (SBIR) grant from the National Institute of Neurological Disorders and Stroke at NIH
● 2022: $81,000 in cumulative funding from the North Carolina Department of Commerce’s One NC Small Business Program as a supplement to the SBIR grant
● 2023: $5.6 million award from the Congressionally Directed Medical Research Programs, U.S. Department of Defense
Along the way, Olfax has used these funds to build clinical and business operations around Relaspen.
Unlike many other life sciences startups that emerge from university research, Olfax traces its origins to an innovation from one clinician. Jason Cook, MD, the company’s founder and chief medical officer, had to put together his support network to launch the company while continuing his work as leader of the headache clinic at Asheville’s Family Health Centers.
Avoiding Opioid-Based Treatment
Cook wanted to find a way to curb the use of opioid injections to treat acute intractable migraine, a type of severe headache that persists for at least three days. So he began performing a procedure known as sphenopalatine ganglion block (SPG block), which involves inserting a needle or catheter with an anesthetic into the posterior nasal cavity. The procedure was first developed in the 1920s.
SPG blocks typically involve lengthy and uncomfortable in-office visits for patients. Through Asheville’s entrepreneurial community, Cook met Beckwith, and the two began exploring how to make the benefits of SPG treatment available to patients with an easy-to-use, at-home method.
“Migraine is the second-largest disabling illness in the world,” behind depression, Beckwith said. “There’s a portfolio of potential medications people can take. But migraines aren’t the same for everyone. Not every drug works for every person. So there’s a lot of opportunity to bring something new that people could benefit from.”
As Relaspen moves toward clinical evaluation, Olfax is preparing to raise additional funding in 2025. This means a parallel path of pursuing follow-on grant opportunities and a Series A investment, Beckwith said.
Asheville as Entrepreneurial Hub
Now seven years into their journey, Beckwith and Cook rely on a team of more than 20 independent contractors to help with research, clinical, operational, regulatory and other functions. The third member of the executive team is Wes Cook, Jason Cook’s brother, who serves as co-founder and chief operating officer.
Beckwith said he wants other life sciences entrepreneurs to see there are benefits to launching a company in places other than traditional research hubs such as Research Triangle Park.
“When I came to Asheville, I saw a big opportunity,” said Beckwith, a Tennessee native. “It’s different from the Triangle. There’s not a lot of university IP presence here, but we do have a lot of clinicians and a growing emphasis on economic development. My experience has been that if you have clinicians, you have a wealth of good ideas ready to be transformed into meaningful products.
“If you can make the ecosystem work, where you’re putting people together and you put all the resources behind it, you can grow. NCBiotech is a key part of the ecosystem.”
Jonathan Snover, executive director of NCBiotech’s Western Regional Office in Asheville, said Olfax is an example of entrepreneurial excellence in Western North Carolina.
“The Olfax Medical team has taken a promising idea and propelled it forward, one step at a time,” he said. “Their model of seeking out every available resource to build a business is an example other entrepreneurs in the region can follow.”