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Bonti Announces Successful Completion of Phase 2a Scar Reduction Clinical Study


SHINE-1 Results Suggest EB-001A May Improve Appearance of Scars

Bonti, a privately-held, clinical-stage biotechnology company, today
announced the topline results of its SHINE-1 Phase 2a clinical trial,
the first clinical trial in its SHINE (Scar
Healing Improvement
with Neurotoxin E)
clinical program, aimed at scar reduction. SHINE-1 evaluated EB-001A,
Bonti's aesthetic product candidate, for scar reduction following Mohs
surgery. This pilot trial achieved its objectives in showing a favorable
safety profile and suggesting promising clinical efficacy. The trial
also provided valuable insights into the scar assessment scales, that
will guide selection of outcomes in future trials.

EB-001, the active ingredient in EB-001A, is a novel botulinum
neurotoxin serotype E (BoNT/E) with a unique clinical profile,
characterized by a faster onset of action (within 24 hours) and a
shorter duration of activity (2 to 4 weeks) compared to botulinum
neurotoxin serotype A (BoNT/A) products. Considering the potential
advantages of this profile, Bonti continues developing products to
pursue targeted aesthetic and therapeutic indications, with its product
candidates EB-001A and EB-001T, respectively, in areas of unmet needs
with significant addressable market opportunities.

In this trial, EB-001A or placebo was administered to the frontalis
muscle immediately after Mohs surgery for skin lesions in the forehead
in 12 subjects (8 active, 4 placebo) who were followed up to 90 days.
EB-001A was well tolerated with no drug-related adverse events. EB-001A
appeared to provide maximum benefit during the acute scar formation
phase as the surgical wounds healed. Numerical improvements in clinical
investigator-reported results and in key patient-reported outcomes
suggest EB-001A may improve the wound healing process.

  • Improvement in Scar Appearance: Based on Visual Analog Scale
    (VAS) scores by the investigator on Day 30, EB-001A treated subjects
    showed scars which were about 50% better in appearance compared to
    scars in placebo subjects
  • Subjects Reported Less Itching: At 24 hours post-surgery, none
    of the EB-001A treated subjects reported itching, compared to 75% of
    placebo subjects who reported itching in the same timeframe, based on
    Scar Cosmesis Assessment and Rating (SCAR) scores
  • Subjects Reported Less Pain: At 24 hours and eight (8) days
    post-surgery, the majority of placebo subjects reported pain, while a
    smaller percentage of EB-001A treated subjects reported pain in the
    same timeframe, based on SCAR scores
  • Improvement in Scar Characteristics: EB-001A treated subjects
    showed improvements in patient-reported scar color and scar stiffness,
    as compared to the placebo group, based on Patient and Observer Scar
    Assessment Scale (POSAS) scores

SHINE-1 was a randomized, placebo-controlled, double-blind (subject and
investigator), parallel arm pilot trial designed to evaluate the safety
and efficacy of EB-001A injections in patients undergoing Mohs
micrographic surgery on the forehead. The SHINE-1 study evaluated a
single immediate post-operative treatment of EB-001A intramuscular
injections into the forehead, in a standardized injection paradigm.

"The SHINE-1 study results suggest that EB-001A has the potential to
expedite the healing process and help physicians repair and improve
outcomes of ‘cosmetically sensitive' wounds," said Fauad Hasan, CEO and
co-founder at Bonti. "Additionally, we are buoyed by the enthusiasm from
facial aesthetics thought leaders who previewed the data. This trial
supports the vision to make our faster-acting neurotoxin, EB-001A, a
valuable addition to physicians' aesthetic toolbox to enhance patient
care and to better address patient unmet needs not captured by current
marketed products."

"This initial clinical trial establishes an encouraging foundation for
future studies to confirm EB-001A's potential benefits for patients
concerned about scars following face and neck surgeries," commented
Murad Alam, MD, Vice Chair, and Professor of Dermatology at Northwestern
University's Feinberg School of Medicine and a Mohs surgeon who led the
SHINE-1 study. "The ability to potentially enhance patient outcomes and
satisfaction following high-tension closure procedures is intriguing.
This small proof-of-concept study suggests that EB-001A's novel target
profile, with fast onset and short duration, may decrease some of the
unpleasantness patients endure during wound healing and likely lead to
improved physical appearance of the eventual scar."

SHINE Clinical Program

The SHINE (Scar Healing
Improvement with Neurotoxin
E) clinical program's main objective
is to support Bonti's strategy to expand EB-001A's potential aesthetic
indications. This requires conducting multiple clinical trials, starting
with the Phase 2a study, SHINE-1, in the Mohs surgery model.

About EB-001

Bonti is developing a first-in-class pipeline of proprietary product
candidates based on EB-001, which is derived from botulinum
neurotoxin serotype E (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 action (within 24 hours) and a shorter duration of activity (2
to 4 weeks) compared to BoNT/A products, which have an onset of action
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
aesthetic product candidate, EB-001A, is being initially developed for
glabellar frown lines and for scar reduction following Mohs surgery and
Bonti's therapeutic product candidate, EB-001T, is being developed for
the treatment of focal muscle pain.

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 aesthetic and therapeutic
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.

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