Market Overview

Bonti Announces Start of LANTERN-1 Phase 2 Clinical Study Evaluating EB-001 in Reducing Musculoskeletal Pain


Interim Data Anticipated by Year-end 2017

Bonti, a privately-held, clinical-stage biotechnology company, today
announced the initiation of its LANTERN clinical program aimed at
relieving musculoskeletal pain and reducing use of opioids using its
neurotoxin platform. The first clinical study, LANTERN-1, one of two
Phase 2 clinical studies, is a placebo-controlled, double-blind
ascending dose cohort trial to evaluate the safety and efficacy of
EB-001 intramuscular (IM) injections in subjects undergoing elective
augmentation mammoplasty (breast augmentation). EB-001 is a novel
serotype E botulinum neurotoxin (BoNT/E) with a unique product
profile, characterized by fast onset of action (about 24 hours) and
short duration of effect (about 4 weeks). Leveraging the benefits of
this profile, Bonti is developing products to pursue areas of unmet
medical need with significant addressable market opportunities.

The recent successful completion of a proof of concept Phase 2A clinical
study established efficacious and safe doses of EB-001 in the treatment
of glabellar (frown) lines. Dosing data from that study confirmed dose
selection for the LANTERN Phase 2 studies. The LANTERN-1 study is a
single intra-operative treatment of EB-001 IM injections into the
pectoralis major (PM) which will be administered in subjects undergoing
breast augmentation. The primary outcome measure is the subject's
assessment of pain using the Numeric Pain Rating Scale (NPRS). Interim
clinical results from the LANTERN-1 Phase 2 study are expected by
year-end 2017.

"We are excited about the commencement of our LANTERN clinical program.
As a locally administered biologic, EB-001 has the potential to address
pain without the addiction risks or the side effects of current
analgesic treatments," commented Fauad Hasan, co-founder and CEO at
Bonti. "The start of this Phase 2 study is a significant milestone
toward successfully establishing EB-001 as a long-acting, non-opioid
solution for the treatment of focal musculoskeletal pain. Our aim is to
make EB-001 available as quickly as possible to help address the opioid
epidemic affecting millions in the U.S. annually."

Countless people experience musculoskeletal pain due to surgery, overuse
(wear and tear) or other injury of muscles, causing muscle spasms and
hyperactivity. Pain reaches extremes after many surgical procedures and
in other medical conditions when it results from incised and stretched
muscles or muscle tension. Current pain relief medications such as
systemic opioids and muscle relaxants and even locally administered
anesthetics only mask symptoms and fail to treat the muscle
hyperactivity, muscle spasms and muscle contraction which are root
causes of pain.

"EB-001 has the potential to be one of the most meaningful pain
management advances in decades for post-surgical and non-surgical care
where opioids have long been the standard of care because of their
efficacy, despite their side effects and risks," added Valerie Lemaine,
MD, MPH, Assistant Professor of Plastic Surgery at Mayo Clinic in
Rochester, Minnesota and a Bonti advisor. "As a surgeon, I seek to
provide my patients the best outcomes possible so they recover as
rapidly and comfortably as possible and EB-001 has the promise to help
me achieve this goal while helping stem the crisis we currently face
with opioids. EB-001's fast onset and short duration target profile will
make a promising addition to our multi-modal pain relief options for
pain management following breast surgeries."

LANTERN Clinical Program

The LANTERN (Long-Acting
Relief, Non-opioid)
clinical program's key objective is to support Bonti's strategy of
seeking broad label approval of EB-001 for the treatment of focal
musculoskeletal pain. This requires conducting two successful
registration trials in two different musculoskeletal models starting
with Phase 2 studies LANTERN-1 (Breast Augmentation) and LANTERN-2

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.

For more information, please visit

View Comments and Join the Discussion!