Market Overview

Bonti Announces Start of LANTERN-2 Phase 2 Clinical Trial Evaluating EB-001T in Treating Focal Muscle Pain

Share:

Follows Completion of LANTERN-1 Clinical Trial

Bonti, Inc., an innovative clinical-stage biotechnology company focused
on the development and commercialization of novel, fast-acting
neurotoxin products for therapeutic and aesthetic applications, today
announced it has initiated dosing in its LANTERN-2 clinical trial, a
Phase 2 clinical trial under Bonti's LANTERN (Long-Acting
NeuroToxin-E
Relief, Non-opioid)
clinical program aimed at treating focal muscle pain and reducing use of
rescue medications, including opioids. LANTERN-2 is a randomized,
placebo-controlled, ascending dose, double-blind clinical trial to
evaluate the safety and efficacy of intramuscular (IM) injections of
Bonti's therapeutic product candidate, EB-001T, in subjects undergoing
elective abdominoplasty (tummy tuck) surgery. EB-001, the active
ingredient in both EB-001T and Bonti's aesthetic product candidate,
EB-001A, is derived from botulinum neurotoxin serotype E (BoNT/E) and is
designed to have a differentiated clinical profile with a faster onset
of efficacy (within 24 hours) and a shorter duration of activity (2 to 4
weeks) than botulinum neurotoxin serotype A (BoNT/A) products. EB-001T
and EB-001A are being developed to address areas of unmet therapeutic
and aesthetic need.

Dose selection for the LANTERN-2 trial was based on favorable safety
results from the recently completed LANTERN-1 clinical trial, which was
Bonti's first trial in the LANTERN program. LANTERN-1 was a Phase 2
clinical trial evaluating EB-001T in subjects undergoing elective
mammoplasty (breast augmentation), in which EB-001T showed favorable
safety in a wide dose range and was well tolerated, and in which the
maximum tolerated dose was not reached. The highest EB-001T dose tested
in LANTERN-1 was 8-fold higher than the maximal dose in Bonti's
previously successful clinical study in the glabellar frown lines model.
LANTERN-1 therefore helped establish a safe dose range for use in larger
muscles that will be injected to treat focal muscle pain in LANTERN-2.

The LANTERN-2 trial comprises a single intra-operative administration of
EB-001T IM injection into the rectus abdominis (RA) muscle in subjects
undergoing abdominoplasty with plication of the RA sheath. The primary
endpoint in this trial will be reduction of post-operative pain at rest
as measured by the Numeric Pain Rating Scale (NPRS) over the first 96
hours. Secondary endpoints include NPRS during activity and patient use
of rescue medications, including opioids, to address unrelieved pain.
Bonti expects topline results of this trial in the fourth quarter of
2018.

"We are excited about the key findings from our LANTERN-1 clinical
trial, as they allow us to expand our LANTERN clinical program into a
well-established model of post-operative pain," said Fauad Hasan, CEO
and co-founder at Bonti. "EB-001T has the potential to be an effective
locally acting pain treatment that addresses a root cause of pain by
decreasing muscle hyperactivity and spasms following surgery and in
non-surgical cases. EB-001T may help healthcare providers and patients
reduce the use of opioids, with their associated side effects and risk
of addiction. We continue to press ahead toward the objective of
establishing EB-001T as a long-acting, non-opioid solution for the
treatment of focal muscle pain."

"As I continuously strive to optimize outcomes for my abdominoplasty and
other surgery patients, Bonti's EB-001T could potentially be an
appealing multi-modal pain management option to provide effective pain
relief following surgery," commented Dr. Alan Matarasso, Clinical
Professor of Surgery at PS Hofstra University – Northwell Health
Systems, renowned aesthetic plastic surgeon in practice in Manhattan and
currently a Bonti Medical Advisor. "Abdominoplasty is a very painful
procedure, where the potential source of post-operative pain is muscle
trauma due to plication of the rectus sheath and tightening of the
muscular abdominal wall. Helping my patients recover faster, better and
with potentially less opioid use following their abdominoplasties are
significant goals which EB-001T, with its fast onset of effect, may help
me achieve successfully."

Bonti estimates that there are approximately 11 million surgical
procedures and 7 million non-surgical treatments annually in the U.S.
that are associated with significant focal muscle pain. Focal muscle
pain is localized pain that can be caused by muscle contractions and
spasms, which can occur as a result of surgical procedures or
non-surgical muscle trauma. Current pain relief medications such as
opioids, local anesthetics, nonsteroidal anti-inflammatory drugs and
acetaminophen are not specifically indicated for focal muscle pain and
may target pain from a systemic point of view, causing common central
nervous system side effects.

LANTERN Clinical Program

The LANTERN (Long-Acting
NeuroToxin-E
Relief, Non-opioid)
clinical program's key objective is to provide a basis for a broad label
for EB-001T for the treatment of focal muscle pain, an indication with
no currently approved therapies.

About EB-001

Bonti is developing a first-in-class pipeline of proprietary product
candidates based on EB-001, which is derived from BoNT/E. BoNT/E has a
validated mechanism of action similar to that of currently approved
products derived from BoNT/A, but, based on preclinical and clinical
data, BoNT/E has a faster onset of efficacy (within 24 hours) and a
shorter duration of activity (2 to 4 weeks) compared to BoNT/A products,
which have an onset of efficacy of approximately 3 to 7 days and a
duration of activity of approximately 3 to 4 months. Based on this
differentiated clinical profile, Bonti's therapeutic product candidate,
EB-001T, is being developed for the treatment of focal muscle pain, and
Bonti's aesthetic product candidate, EB-001A, is being initially
developed for glabellar frown lines and for scar reduction following
Mohs surgery.

About Bonti

Bonti, based in Newport Beach, CA, is an innovative clinical-stage
biotechnology company focused on the development and commercialization
of novel, fast-acting neurotoxin products for therapeutic and aesthetic
applications. The company was founded and is led by executives with
extensive experience obtained at Allergan plc with botulinum neurotoxin
products from discovery, clinical, supply chain, regulatory and
commercialization perspectives. By turning the science of neurotoxins
into beneficial patient and healthcare provider solutions, Bonti seeks
to improve lives by successfully addressing key unmet needs in markets
with significant addressable opportunities.

For more information, please visit http://bonti.com.

View Comments and Join the Discussion!