AOBiome's 576 patient Phase 2b trial commences patient enrollment
CAMBRIDGE, Massachusetts,
June 30, 2020 /PRNewswire/ -- AOBiome
Therapeutics, Inc. ("AOBiome"), a leading clinical-stage microbiome
company focusing on inflammation, announced initiation of a
Phase 2b clinical trial in pruritus
(itch) associated with atopic dermatitis based on positive clinical
trial results related to the investigation of its lead product
candidate, B244, in patients with atopic dermatitis (eczema) in a
Phase 2a clinical trial in adults, as well as a Phase 1b clinical trial in pediatric patients.
The adult trial was a double blind, placebo controlled,
multicenter, Phase 2a study of B244, a first-in-class, topical
formulation of beneficial ammonia oxidizing bacteria, delivered as
a topical spray twice daily for 28 days. This trial was
designed to assess safety and efficacy in 122 patients 18 years and
older with mild-to-moderate pruritus associated with atopic
dermatitis. Patients receiving the investigational drug
achieved a statistically significant improvement in their pruritus
over patients receiving placebo (p value = 0.01) after two
weeks. In addition, 23% of patients receiving the drug
achieved at least a 4 point improvement (out of 10) utilizing the
visual analog scale (VAS) for pruritus, versus 6% of patients
receiving placebo. B244 was very well tolerated and side effects of
the active were equal to that of the placebo. This was
consistent with all previous trials the company has completed with
this drug. Typical itch drugs take significantly longer to show
improvement, highlighting a significant market opportunity for the
company.
The pediatric trial was an open-label, single dose level,
multicenter, Phase 1b study of the
B244 topical formulation, administered twice daily and was designed
to assess its safety and tolerability in 28 pediatric patients aged
2 to 17 years with mild-to-moderate atopic dermatitis over a 28-day
period. The drug was very well tolerated. 28% of
patients achieved at least a two point (out of 5) improvement on
the ITCHMAN pruritus scale at week four and 64% achieved at least a
1 point improvement.
Based on these early efficacy signals, a double blind,
randomized, placebo controlled, multicenter, Phase 2b dose selection study was initiated to evaluate
the efficacy, safety, and tolerability of B244 topical spray twice
daily for 28 days for the treatment of pruritus in 576 adults with
a history of mild-to-moderate atopic dermatitis. Patient
enrollment has begun, with approximately 50 US sites across 27
states participating in this trial. Primary efficacy endpoint
and key secondary efficacy endpoint will include mean change in
Worst Itch Numeric Rating Scale (WI-NRS) from baseline to week
4 and proportion of subjects with ≥4 point improvement in
WI-NRS from baseline to week 4, respectively. The Itch NRS is
a validated, self-reported instrument for measurement of itch
intensity. Additionally, endpoints of Investigator Global
Assessment (IGA) and Eczema Area and Severity Index (EASI) for
Atopic Dermatitis will be captured. As this trial will be
conducted during the COVID-19 era, patient and site staff safety
will be of paramount concern. AOBiome has implemented a
comprehensive risk mitigation plan to ensure such safety.
"There is a significant medical need for new therapies to treat
both adults and children with itch associated with atopic
dermatitis. In younger populations, itch can be the primary
complaint and can exacerbate the severity of disease through an
itch-scratch-lesion worsening cycle. Our safety profile and
rapid onset of efficacy has led us to focus on pruritus as the lead
indication in our next clinical trial," said President & CEO,
Todd Krueger. "We look forward to
announcing results from this study in 2021."
In the United States, 12% of
children (or 9.6 million) under the age of 18 years suffer from
eczema and associated pruritus.1 Of these,
approximately one third have moderate to severe cases. 7% of
adults in the US suffer from eczema and associated pruritus.
"The potential beneficial effect of B244 on atopic dermatitis
and its associated pruritus is multi-pronged. Pruritus relief
may be mediated through an immunomodulatory mechanism of
action. Pre-clinical results have shown that the bacteria
exert an anti-inflammatory effect on certain markers associated
with itch. Company studies have also shown the potential
antimicrobial mechanism of action that contribute to the reduction
of pathogenic bacteria infecting the established skin lesions,"
said Board of Director, Dr. Annalisa
Jenkins, MBBS MRCP. "Furthermore, current therapies for
pruritus can cause local side effects such as stinging, burning,
and thinning of skin, especially in pediatric patients. B244's
innovative nature represents a novel therapeutic opportunity to
safely address the medical needs of patients.
Additional information regarding this and AOBiome's other
ongoing clinical programs may be found
at www.clinicaltrials.gov.
About Ammonia Oxidizing Bacteria (AOB)
AOBiome's AOB platform is a patented, proprietary, topical and
intranasal formulation incorporating a single strain of beneficial
AOB, Nitrosomonas eutropha. The platform is designed to
repopulate the skin or nasal microbiome with AOB. Once deployed,
AOB produces nitric oxide, a signaling molecule known to regulate
inflammation and vasodilation.
About AOBiome Therapeutics, Inc.
AOBiome Therapeutics, Inc. is a Cambridge, MA-based life sciences company
focused on transforming human health by developing microbiome-based
therapies for local, nasal and systemic inflammatory conditions.
Founded in 2012 by PatientsLikeMe founder Jamie Heywood and MIT-trained Chemical Engineer David Whitlock, AOBiome is advancing a pipeline
of multiple, clinical-stage therapeutic candidates. The company's
portfolio includes multiple clinical-stage programs: a completed
Phase 2 study to treat patients with acne vulgaris or acne, a Phase
1b study to treat patients with
pediatric eczema (atopic dermatitis), a Phase 2 study to treat
patients with adult eczema (atopic dermatitis), a Phase 2 study for
the prevention of episodic migraines, and a Phase
1b/2a clinical trial for the
treatment of allergic rhinitis, as well as earlier-stage
preclinical programs targeting diverse inflammatory indications.
Learn more at www.aobiome.com.
Contacts:
For Media Inquiries:
Jim Hoffman
845-417-3487
Jim@AOBiome.com
1 Hanifin J, Reed M. A Population-Based Survey
of Eczema Prevalence in the United
States. Dermatitis. 2007;18(2):82-91.
doi:10.2310/6620.2007.06034.
2 Gustafsson, D., et al. "Development of Allergies
and Asthma in Infants and Young Children with Atopic Dermatitis – a
Prospective Follow–up to 7 Years of Age." The Canadian
Journal of Chemical Engineering, Wiley-Blackwell, 9 Oct. 2008,
onlinelibrary.wiley.com/doi/abs/10.1034/j.1398-9995.2000.00391.x.