Santalis Pharmaceuticals Announces Positive Results from a Study of Pediatric Patients with Eczema (Atopic Dermatitis) Treated with the Santalia™ AD Over the Counter Therapy Regimen

Guía de Regalos

SAN ANTONIO–(BUSINESS WIRE)–Santalis Pharmaceuticals today announced positive preliminary results
from its expanded study of its Santalia™ AD product regimen (serum,
cleanser and bubble bath). The Santalia™ AD OTC products all contain
East Indian sandalwood oil (EISO) and colloidal oatmeal to treat the
symptoms of pediatric eczema (atopic dermatitis). EISO has been
demonstrated to inhibit a broad range of inflammatory pathways thought
to underlie this skin condition, as well as many pathogens associated
with secondary infections of eczema, such as Staphlococcus aureus
(“staph”). The results of this study show Santalia™ AD to be safe, well
tolerated, and efficacious for patients aged between 3 months to 12
years who have mild, moderate or severe eczema affecting a large
percentage of their body surface area. The treatment regimen comprised a
twice-daily application of the serum and cleanser to the affected areas
and a bubble bath used three times a week

“The results of this study are very encouraging. The Santalia™ AD kit
had a significant impact on the quality of life of these patients and
their parents. The results seen were better than had been previously
achieved by these patients from the use of other topical treatments,
including both over-the-counter and prescription drugs. This improvement
is further evidenced by the number of parents asking to continue using
the product kit after the study had finished. The Santalia™ AD OTC kit
should be the first choice for parents before visiting the doctor’s
office,” said John Browning, M.D., Assistant Professor of Pediatrics and
Dermatology at Baylor College of Medicine and Chief of Dermatology at
Children’s Hospital of San Antonio.

“This shows clearly the significant benefit of Santalia™ AD, a
combination of EISO and colloidal oatmeal, in the OTC treatment of young
children, where the choice of effective and safe products is limited,”
said Paul Castella, Chief Executive Officer of Santalis Pharmaceuticals.
“This OTC study provides additional support for our EISO-based
prescription drug program for eczema, which we intend to start later
this year with the initiation of placebo-controlled clinical studies.”

The results from the study have been submitted for publication and the
Santalia™ AD OTC kit should be available for distribution at the start
of 2017.

Santalia™ AD Regimen

The single-center, open-label study enrolled 25 patients, ages 3 months
to 12 years with mild, moderate or severe atopic dermatitis with a mean
beginning Eczema Area and Severity Index (EASI) score of 11.1
(moderate). Treatable atopic dermatitis, for this study, was defined as
an EASI score ≥5 but ≤ 52. The EASI scoring system is a validated
investigator-assessed instrument, which measures the severity of
clinical attributes of atopic dermatitis in patients. Patients (or their
caregivers) were instructed to apply the Santalia™ AD Regimen cleanser
and cream twice daily for 60 days and bubble bath at least three times
weekly.

Safety, tolerability and efficacy endpoints were all included as a part
of this study. Safety evaluation included an assessment of safety based
on the frequency and severity of systemic and local adverse events (AEs)
when the Santalia™ AD Regimen is applied to pediatric and adolescent
patients with atopic dermatitis for up to 60 days. Tolerability was
determined by the number and percentage of patients reporting burning,
itching, scaling, erythema, dryness, or stinging of the treatment
area(s). Primary efficacy was determined by the percentage of patients
who had at least a 25% improvement in the EASI score at any time point
during the 60 days of therapy.

Secondary efficacy endpoints included patients having a >25%-50%
improvement in EASI score at Visit 6, >51% improvement in EASI score at
Visit 6, and descriptive assessments of improvement in the severity and
extent of disease based on the Investigator Global Assessment at Visit 6
as well as a comparison of Baseline and Visit 6 Children’s Dermatitis
Life Quality Index (CDLQ) or Infant Dermatitis Quality of Life Index
Questionnaire (IDQoL). The Investigator Global Assessment is a 5-measure
scale, from “worse” to “very much improved,” recording the change in a
patient’s atopic dermatitis at each visit compared to the status of the
condition at baseline.

Efficacy

  • 22 out of 25 patients completed the study
  • 82% (18/22) of patients met the primary efficacy endpoint (a 25%
    reduction in their EASI score)
  • 91% (20/22) of patients experienced a reduction in their EASI score
  • 68% of patients achieved an IGA score of “much improved” or “very much
    improved” with a minimum 2-grade improvement after four weeks of
    treatment
  • 61.9% of patients achieved an IGA score of “much improved” or “very
    much improved” with a minimum 2-grade improvement after four weeks of
    treatment
  • Patients demonstrated an average 60% reduction in EASI score over
    Baseline
  • In patient diary responses, the aggregate score for all diary
    responses went from 0 at study commencement to 3.1 (much Improvement)
    in 8 weeks
  • 74.7% of respondents reported an aggregate score of 3 (much
    improvement) or 4 (very much improved) at study end
  • 78.9% reported a reduction in both redness and an improvement in skin
    texture of the treated area and 73.7% reported an improvement in pain
    or irritation of the treatment area

Safety and Tolerability

The Santalia™ AD Regimen was generally safe and well-tolerated with no
AEs found to be possibly, probably or definitely related to the study
drug.

About Eczema/Atopic Dermatitis

Eczema/atopic dermatitis is a chronic skin condition involving
inflammation and itching. The rash is characterized by red, oozing
patches and thickening of the skin. Rubbing and scratching can lead to
skin damage and secondary bacterial infections. Approximately 18 to 25
million people in the United States are believed to suffer from atopic
dermatitis, with 80% to 90% having mild or moderate disease. It is
estimated that the incidence of the disease amongst infants and children
in the US is between 8% and 18%. Though most common in the pediatric
population, about half of childhood cases carry over into adulthood.
There is currently no cure for atopic dermatitis and current therapies
are primarily palliative, focused on reduction of symptoms (redness,
itching, etc.). Moisturizers, anti-inflammatory drugs, phototherapy and
other approaches are often used. Long-term use of many of the current
treatments is often not effective or can lead to complicating side
effects.

About Santalis Pharmaceuticals

Santalis Pharmaceuticals, Inc. is a wholly-owned subsidiary of TFS
Corporation, Ltd. (ASX: TFC). Santalis, and its sister company, ViroXis,
were acquired by TFS in July 2015 and are developing scientifically and
clinically validated over the counter and prescription products that
utilize TFS’ cultivated, sustainable, pharmaceutical-grade East Indian
Sandalwood Oil. Santalis’ product development programs are focused in
oral health and dermatology, where EISO’s well documented safety and
anti-infective, anti-proliferative and anti-inflammatory properties are
well suited to a number of prevalent and under­served conditions (such
as acne, eczema, psoriasis, oral mucositis, onychomycosis, HPV skin
warts and Molluscum Contagiosum). In addition to an eczema program
study, Santalis has ongoing Phase 2 studies in pediatric Molluscum
contagiosum, oral mucositis, and psoriasis, and is preparing to initiate
a Phase 3 study for pediatric HPV skin warts.

About East Indian Sandalwood

Indian sandalwood has a history as a tradeable commodity spanning
thousands of years, but is now endangered due to the illegal harvest of
wild trees throughout the world. As a result, Indian sandalwood is the
world’s most expensive tropical hardwood. Indian sandalwood oil is a
globally important ingredient in fine fragrances, cosmetics and
toiletries, Indian consumer products and is used for traditional
medicinal purposes (Ayurvedic and Chinese medicine). The wood is used
for high quality carvings and artefacts and religious worship in the
Hindu and Buddhist faiths. The global pharmaceutical market has the
potential to be a significant consumer of Indian sandalwood.

Contacts

Santalis Pharmaceuticals, Inc.
Jim Traa, CBO, 210-399-2318
jim@santalispharma.com