Market Overview

Bonti Announces Topline Results of EB-001 Phase 2A Clinical Study in Glabellar Lines


First Clinical Study with Novel Serotype E Botulinum Toxin Confirmed
Favorable Safety and Differentiated Efficacy Profile

Bonti, a privately-held, clinical-stage biotechnology company, today
announced topline results of the first clinical study of its lead
product candidate, EB-001, in glabellar (frown) lines. The study
achieved its objectives and confirmed both favorable safety and the
expected clinical efficacy profile. EB-001 is a novel serotype E botulinum
neurotoxin with a unique efficacy profile, characterized by fast onset
of action (about 24 hours) and short duration of effect (about 4 weeks).
EB-001 is being developed for aesthetic and therapeutic indications with
significant addressable market opportunities.


Efficacy Results: EB-001 demonstrated dose-dependent clinical
activity and efficacy at multiple doses. At the high dose cohorts, a
2-point response (assessed by the investigator) was observed within 24
hours of injection. At the two high doses, a 2-point response was
reported in 80% of EB-001 subjects and in 14% of the placebo group. The
duration of clinical effect was two to four weeks post-injection in the
high dose groups.

Safety Results: A total of 42 subjects were enrolled and received
study drug. All doses evaluated in the study were well tolerated and
there were no serious adverse events (SAEs), or discontinuations due to
adverse events (AEs). The overall incidence of treatment-emergent AEs
was 14% of EB-001 subjects, and included headache, sore throat and
flu-like symptoms, and was 0% in the placebo group. These were transient
and mild or moderate in severity. There were no AEs related to local
spread of toxin, e.g., no eyelid drooping (ptosis), reported at any dose.

Dosing Implications: This study confirmed the efficacious dose
range of EB-001 in the treatment of glabellar lines. Dosing data from
this study will inform dose selection for future studies, including a
Phase 2B glabellar lines study and Phase 2 studies supporting Bonti's
therapeutic program in the treatment of focal musculoskeletal pain.

Study Design

GL-201 was a randomized, double-blind, placebo-controlled, ascending
dose cohort study conducted at two U.S. sites. A total of 42 subjects
were randomized to the seven cohorts, 35 received active drug and seven
received placebo. The study enrolled toxin naïve adults with moderate to
severe glabellar (frown) lines and each subject received a single
treatment cycle comprising five injection sites in the forehead
glabellar muscles.

"The conclusion of this landmark first-in-human clinical study along
with its positive results are tremendously exciting and pivotal for the
Bonti team and for our overall development efforts," said Fauad Hasan,
co-founder and CEO at Bonti. "We are exceptionally grateful to our
clinical investigators and to the subjects in the study. As we
previously remarked, the results from this study are important in
addressing significant unmet needs in facial aesthetics. They also
enable us to move forward with our therapeutic development efforts to
evaluate EB-001 as a long-acting, non-opioid solution for the treatment
of focal musculoskeletal pain which will help address the raging opioid
epidemic affecting millions in the U.S. annually."

"I was excited to study this investigational drug and believe that
EB-001's unique product profile differentiates it from, and ultimately
complements, the botulinum neurotoxins currently on the market,"
commented Dr. Steve Yoelin, one of the study's principal investigators.
"EB-001 will likely expand the aesthetic market because it appears well
suited to treat both neurotoxin-naïve patients looking to sample
neurotoxins using a short-duration variant such as EB-001 as well as
current neurotoxin patients looking to supplement their treatments.
EB-001 has the potential to improve all injectors' ability to obtain the
very best outcomes for their respective patients."

About Dr. Steve Yoelin

Dr. Yoelin is a board-certified physician who currently practices in
Newport Beach, CA and has been a thought leader in the clinical and
research fields. For the past decade, he has developed an unprecedented
expertise in facial aesthetics including the use of neurotoxins, dermal
fillers and collagen stimulators. Dr. Yoelin is focused on innovation
and has served as lead investigator in several pilot studies for novel
agents, including one that led to a first-in-class FDA approved
aesthetic product. Dr. Yoelin has lectured extensively on the use of
facial injectables at numerous educational events in the U.S. and at
international conferences.

About EB-001

Bonti's lead product candidate, EB-001, is an investigational botulinum
neurotoxin serotype E (BoNT/E). EB-001 has a mechanism of action similar
to the marketed botulinum neurotoxin serotype A (BoNT/A) products
though it has a differentiated clinical profile. EB-001 has a fast onset
of action (about 24 hours) and short duration of effect (about 4 weeks).
Currently marketed BoNT/A products have an onset of action around 3-7
days and a duration of effect around 3-4 months. The unique target
clinical profile of EB-001 is well suited for a vast range of aesthetic
and therapeutic uses, including for the treatment of post-surgical and
non-surgical musculoskeletal pain, with currently unmet needs.

About Bonti

Bonti, based in Newport Beach, California, is a rapidly emerging
biotechnology company founded by world class neurotoxin experts with
proven success at Allergan, one of the Fortune 500 fastest growing
pharma companies. This team, with unsurpassed neurotoxin, aesthetic and
pain expertise, is uniquely qualified to develop unprecedented treatment
paradigms driven by a novel neurotoxin platform to become an innovative
leader in both aesthetic and therapeutic markets. By turning the science
of neurotoxins into beneficial patient and healthcare provider
solutions, Bonti will improve lives by successfully addressing key unmet
needs in markets with significant addressable opportunities.

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