Ritter Pharmaceuticals Phase 2a Lactose Intolerance Clinical Trial Microbiome Data, Published in Proceedings of the National ...
January 03 2017 - 12:34PM
Marketwired
Ritter Pharmaceuticals Phase 2a Lactose Intolerance Clinical
Trial Microbiome Data, Published in Proceedings of the National
Academy of Sciences
LOS ANGELES, CA-(Marketwired - Jan 3, 2017) - Ritter
Pharmaceuticals, Inc. (NASDAQ: RTTR) ("Ritter Pharmaceuticals" or
the "Company"), a developer of novel therapeutic products that
modulate the human gut microbiome to treat gastrointestinal
diseases, today announced that clinical microbiome data from its
Phase 2a clinical trial of RP-G28 in patients with lactose
intolerance were published in the Proceedings of the National
Academy of Science ("PNAS-Plus") PNAS 2017; Early Edition,
published ahead of print January 3, 2017.(1)
The paper titled, "Impact of short-chain galactooligosaccharides
on the gut microbiome of lactose-intolerant individuals," reports
findings on the Company's lead therapeutic candidate, RP-G28, a
short-chain galactooligosaccharide ("GOS"). The data validates
RP-G28's mechanism of action and supports the product as a
potential treatment for lactose intolerance. The newly published
microbiome data provides further insight into RP-G28's Phase 2a
2013 clinical trial(2), which has lead to a Phase 2b/3 377-subject
clinical trial (results expected in 2017).
The results of the study demonstrated that RP-G28 significantly
modulated the gut microbiome composition of lactose intolerant
individuals. Significant changes in the diversity of the microbiota
occurred in GOS/RP-G28 treated subjects upon reintroduction of
dairy into the diet. Key bacterial taxa changes included increases
in lactose-fermenting Bifidobacterium, Lactobacillus and
Faecalibacterium, and those changes correlated with a symptomatic
improvement in tolerance to lactose (the sugar present in dairy
foods). Notably, 90% of the RP-G28 treatment group showed a
bifidogenic response compared to other GOS studies, which reported
a bifidogenic response in 50% of the treated subjects.(3)
The study was a multi-center, randomized, double-blinded,
placebo-controlled Phase 2a trial to evaluate whether a shift
occurred in the fecal microbiome of lactose-intolerant human
subjects who were treated with RP-G28 and a dairy diet and who
exhibited a clinical response toward lactose tolerance. The study
evaluated a patient's ability to consume dairy foods after first
feeding RP-G28 for 35 days, followed by 30 days of introducing
dairy products into the diet. A total of 85 subjects were enrolled
in the trial with 57 randomized to receive RP-G28 and 28 in the
placebo group. Andrea Azcarate-Peril, PhD, from the Department of
Medicine, and Director of the Microbiome Core Facility, School of
Medicine, University of North Carolina, Chapel Hill ("UNC") and
Distinguished University Professor, Todd Klaenhammer, PhD, from the
Department of Food, Bioprocessing & Nutrition Sciences, North
Carolina State University, Raleigh, NC ("NCSU") conducted the
analysis.
The microbiome analysis also uncovered other potentially
health-promoting bacteria, specifically Faecalibacterium, that were
enhanced by feeding RP-G28. This suggests that RP-G28 might have
potential therapeutic benefits in inflammatory bowel disease and
metabolic syndrome, among other diseases.
"Demonstrating that RP-G28 can increase key lactose-fermenting
bacteria associated with symptom improvements sheds light on
potential mechanisms of action for treating lactose intolerance,"
said Andrew J. Ritter, President of Ritter Pharmaceuticals. "The
results of this analysis are consistent with our hypothesis of how
the therapeutic may work and increases our confidence that it will
be an effective option for patients seeking solutions for their
lactose intolerance."
Dr. Andrea Azcarate-Peril added, "This is a seminal study
producing some of the first data in lactose intolerance showing the
microbiome's role in being able to metabolize lactose independent
of host enzymes. Furthermore, it's remarkable that we observed a
definitive shift to being lactose tolerant after a single 35-day
dosing of RP-G28."
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products
that modulate the gut microbiome to treat gastrointestinal
diseases. The Company is advancing human gut health research by
exploring the metabolic capacity of gut microbiota, and translating
the functionality of these microbiome modulators into safe and
effective applications. The Company's lead drug candidate, RP-G28,
has the potential to become the first FDA-approved drug for lactose
intolerance, a condition that affects more than one billion people
worldwide.
Forward-Looking Statements
This release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements related to our Phase 2b/3 results and clinical
development of RP-G28. Management believes that these
forward-looking statements are reasonable as and when made.
However, such statements involve a number of known and unknown
risks and uncertainties that could cause the Company's future
results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by
such forward-looking statements. These risks and uncertainties
include, but are not limited to, risks associated with the drug
development process generally, including the outcomes of planned
clinical trials and the regulatory review process. For a discussion
of certain risks and uncertainties affecting Ritter
Pharmaceuticals' forward-looking statements, please review the
Company's reports filed with the Securities and Exchange
Commission, including, but not limited to, its Annual Report on
Form 10-K for the period ended December 31, 2015 and Quarterly
Reports on Form 10-Q for the periods ended March 31, 2016, June 30,
2016 and September 30, 2016. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date on which they are made. These statements are
based on management's current expectations and Ritter
Pharmaceuticals does not undertake any responsibility to revise or
update any forward-looking statements contained herein, except as
expressly required by law.
(1) http://www.pnas.org/content/early/2017/01/01/16067... (2)
Phase 2a Nutrition Journal Article: Savaiano et al.: Improving
lactose digestion and symptoms of lactose intolerance with a novel
galacto-oligosaccharide (RP-G28): a randomized, double-blind
clinical trial. Nutrition Journal 2013 12:160. (3) Hutkins: Davis
LMG, Martınez I, Walter J, Goin C, Hutkins RW (2011) Barcoded
Pyrosequencing Reveals That Consumption of Galactooligosaccharides
Results in a Highly Specific Bifidogenic Response in Humans. PLoS
ONE 6(9): e25200. doi:10.1371/journal.pone.0025200
Contacts Ellen Mochizuki 310-203-1000 ellen@ritterpharma.com
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