The market opportunity for facial injectables is an attractive one—it’s likely to grow more than 11.5% globally from $6.5 billion last year to $7.2 billion in 2020, according to a recent market research report by Grand View Research Inc. in San Francisco.
It’s dominated by Allergan PLC, but Allergan has only 19% of the total facial aesthetics market with a reported annual revenue of about $1.23 billion in facial aesthetics in 2016.
Newport Beach clinical-stage biotechnology company Bonti thinks it can grab part of that aesthetics market share as it moves its lead neurotoxin candidate, EB-001, into phase three for aesthetics.
But chief executive and co-founder Fauad Hasan is proceeding on a dual track with EB-001, pursuing therapeutic uses of EB-001. Hasan is particularly excited about the possibility of using the neurotoxin for pain management. He’s a former Allergan director of biologics manufacturing and development.
“From day one, our position has been very simple—we have established two separate products, one for pain indication and one for aesthetics. The environment is right for a new pain solution in replacement for opioids,” Hasan said, noting President Donald Trump’s statement this month that he was prepared to officially declare the U.S.’ opioid epidemic a national emergency.
The two indications will be separately branded and marketed, two names for one molecule. The strategy enables the company to avoid pricing challenges stemming from two distinctly different markets—the aesthetic market, which is primarily self-pay, and the therapeutic market, which will likely include reimbursement from insurance.
The company is in the process of completing a phase two trial studying the efficacy of EB-001 in subjects with frown lines. It plans to start phase three next year.
First Study
Bonti separately announced starting “Lantern,” its therapeutic study of EB-001, in a phase two clinical study of the neurotoxin to relieve musculoskeletal pain and reduce use of opioids in subjects undergoing breast augmentation. The study is one of two phase two clinical studies needed for Food and Drug Administration approval.
There are several causes of musculoskeletal pain, including surgery, overuse, and injuries of muscles that cause muscle spasms and muscle hyperactivity.
Hasan said pain management is an indication Allergan hasn’t claimed with Botox.
FDA-approved therapeutic uses of Botox include excessive underarm sweating, chronic migraines, over-active bladder, cross-eye, and severe neck spasms.
“Botox hasn’t been used as effective pain management for spasm and muscle contraction. And [given the] current environment, we can provide a solution through a biologic that has no addictive properties and no [gastrointestinal] issues, like [opioid-induced] constipation,” he said.
Prolonged use of Botox can cause muscle atrophy.
As for aesthetics, Hasan said Bonti’s neurotoxin differs from Botox and isn’t a direct competitor. He said EB-001 is faster acting—about 24 hours, while it usually takes three to five weeks to see the effect of Botox—and lasts for a shorter amount of time, about four weeks. Botox requires reinjection every three to six months.
“The mechanism of action [of our neurotoxin] is similar to Botox, but given the drug profile, we are a complementary drug to Botox,” Hasan said. He said Bonti’s product is good for those who need a quick fix or who are new to Botox. “If they like the effect with our product, they can get Botox, which lasts longer.”
Bonti has raised over $20 million in series A and B. It closed an $11.7 million series B financing in April from lead investor RBV Capital in Russia that included participation from San Diego-based City Hill Ventures, Dallas, Texas-based Colt Ventures, Chinese multifamily office JMCR Partners, Shanghai-based High Light Capital, and individuals. Proceeds from the round will be used to fund clinical trials for aesthetic and therapeutic indications.
The Bonti management team is comprised of former Allergan executives who worked with Botox, including Wajdie Ahmad, chief operating officer and co-founder, and Susan Abushakra, chief medical officer. The company has seven full-time employees and plans to hire up to five more.
Hasan said Allergan’s success with Botox has enabled the company to move quickly on the clinical front. “We are one of the few companies that already have a regulatory pathway [to approval]. We moved to phase two in two years since founding.”
The company is open to “find a partner or go to clinical on our own.”
Hasan said he doesn’t rule out going public next year.
