Ritter Pharmaceuticals Reports Further Analysis from its Phase
2b/3 Trial Results Demonstrating Significant Reductions in Lactose
Intolerance Symptoms
Analysis shows clinically meaningful benefit from symptoms,
global patient-reported and real-world assessments
LOS ANGELES, CA-(Marketwired - Aug 3, 2017) - Ritter
Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company"), a developer
of novel therapeutic products that modulate the human gut
microbiome to treat gastrointestinal diseases today announced
additional findings and data analysis from its Phase 2b/3 study
designed to evaluate lead candidate RP-G28 in subjects with lactose
intolerance.
These additional results from the trial analysis demonstrate
that:
1. A clear drug effect was seen with significant positive
reductions in key symptoms of lactose intolerance (LI) and across a
variety of global and real world outcome measures. 2. The treatment
effect suggests a clinically meaningful benefit to subjects in
significantly reducing symptoms of lactose intolerance. 3. The
study demonstrated safety with no serious adverse events related to
treatment.
According to Andrew J. Ritter, President and co-founder of
Ritter Pharmaceuticals, "As we continue to evaluate the results of
this trial, we are increasingly excited by the strength of the data
supporting RP-G28's potentially significant and durable real-world
treatment effect for patients suffering from lactose
intolerance."
About the Trial and RP-G28
The Phase 2b/3, multi-center, randomized, doubled-blind,
placebo-controlled, parallel-group trial in 377-subjects was
designed to determine the efficacy, safety, and tolerability of two
dosing regimens of RP-G28 in subjects with lactose intolerance.
RP-G28 is a novel, non-digestible oligosaccharide of ultra-high
purity developed to modulate the gut microbiome by stimulating and
adapting the bacteria in the gastrointestinal (GI) tract to
metabolize lactose to improve lactose tolerance.
The trial assessed patients with lactose intolerance symptoms
measured on a Likert scale after a lactose challenge. Symptoms of
abdominal pain, cramping, bloating and gas movement were then
combined into a composite endpoint representing the key symptoms of
lactose intolerance. This composite primary endpoint was agreed-to
by the U.S. Food and Drug Administration (FDA) prior to unblinding
the study results. The Phase 2b/3 trial design included a screening
phase, a 30-day course of treatment phase, and a 30-day
post-treatment "real-world" observation phase during which subjects
were followed while lactose containing food products were
re-introduced into their diets.
Collectively, the majority of analyses showed positive outcome
measures and a clear drug effect and clinically meaningful benefit
to subjects in the reduction of lactose intolerance symptoms across
a variety of global and real-world outcome measures,
including:1,2
Key lactose intolerance symptoms assessments
Significant and meaningful symptom improvement was consistently
seen across key individual LI symptoms (proportion of subjects on
treatment that reported improvement in severity of each
symptom):3
- 56% reported significant improvement in abdominal pain
(p=0.1046)
- 55% reported significant improvement in cramping
(p=0.0257)
- 55% reported significant improvement in bloating
(p=0.0282)
- 44% reported significant improvement in gas movement
(p=0.0599)
In a more stringent assessment, many patients reported that they
experienced complete elimination of lactose intolerance symptoms
scoring a 0 out of 10 on a Likert scale post-treatment (proportion
of subjects on treatment that reported complete elimination of each
symptom):
- 31% reported complete elimination of abdominal pain
(p=0.0144)
- 35% reported complete elimination of cramping (p=0.0020)
- 30% reported complete elimination of bloating (p=0.015)
- 16% reported complete elimination of gas movement
(p=0.0005)
Global patient-reported assessments
The patient's perspective on multiple aspects of their symptom
severity and treatment benefit experience 30-days after treatment
and adding dairy and milk products back into their diets:
- 83% of subjects on treatment reported adequate relief from
lactose intolerance symptoms (p=0.042).
- 82% of subjects on treatment reported no or mild symptom
severity (p=0.0013).
- 66% of subjects on treatment reported being very or extremely
satisfied with RP-G28 preventing or treating their lactose
intolerance symptoms (p=0.0302).
- 40% of subjects on treatment reported much or very much
improvement from lactose intolerance symptoms when dairy was
incorporated back into their diets (p=0.0343).
Real-world milk intake assessment
- At baseline, patients reported consuming 0.2 cups/day of milk.
After taking RP-G28, treatment patients increased their milk
consumption to 1.5 cups/day (p=0.0084), 39% more milk consumed per
day than placebo patients reported consuming. This is important
because the USDA recommends that healthy individuals should consume
1.5 cups/day.4
- Overall, 59% of treatment patients consumed >1 cups/day of
milk after being treated (p=0.0095).
- The increase in milk consumption is meaningful for dairy
avoiders because it reflects increased lactose tolerance and may
lead to more dietary calcium intake post-treatment as milk contains
a high percentage of one's daily intake of calcium.
Safety assessments
- Safety was widely demonstrated with no serious adverse events
related to treatment and the number of adverse events reported was
similar between treatment and placebo groups.
The Company has been granted an End of Phase 2 meeting with the
FDA, which will take place by the end of 2017. The End of Phase 2
meeting will be an important opportunity to consult with the FDA on
finalizing the Phase 3 clinical program and identifying the
remaining NDA-enabling package necessary for obtaining commercial
approval of RP-G28 for the treatment of lactose intolerance. In
preparation for the Phase 3 program, the Company has also commenced
manufacturing efforts and plans to commence the Phase 3 clinical
program in the first half of 2018.
"The further on-going analysis of our study data we are
releasing today is proving to be important for demonstrating in the
real-world that treatment with RP-G28 can safely yield both a clear
drug effect and a clinically meaningful benefit for patients by
using a study design and outcome measurements recommended by the
FDA and as reported by patients," according to Michael Step, CEO of
Ritter Pharmaceuticals. "We are looking forward to completing our
Phase 3 program with the ultimate objective of providing a durable
treatment to people who suffer from lactose intolerance."
1. Clinical results analyzed and provided include the Efficacy
Subset Per Protocol population (n=296), excluding inconsistent data
observed from one study center. 2. P-values listed represent
whether a statistical significant difference (defined as a p-value
below 0.05) was met between treatment and placebo group 3.
Meaningful improvement is defined as a patient who reports a
>4-point improvement in a symptom when comparing their
post-treatment score to their baseline score or a score of zero
post-treatment. 4. Bentley, Jeanine. "Trends in U.S. Per Capita
Consumption of Dairy Products, 1970-2012." United States Department
of Agriculture Economic Research Service, 2016.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com,
@RitterPharma) develops novel therapeutic products that modulate
the gut microbiome to treat gastrointestinal diseases. Its lead
product, RP-G28, has the potential to become the first FDA-approved
treatment for lactose intolerance, a condition that affects
millions worldwide. The Company is further exploring the
functionality and discovering the therapeutic potential gut
microbiome changes may have on treating/preventing a variety of
conditions including: gastrointestinal diseases, immuno-oncology,
metabolic, and liver disease.
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 ability to successfully
complete a confirmatory Phase 3 program that will be adequate to
support a NDA submission and to bring RP-G28 to market. 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, risk that the FDA will not agree
with our interpretation of the data results from our Phase 2b/3
clinical trial and our decision to exclude the data from the
outlier center, 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,
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.
Contact Ellen Mochizuki 310-203-1000 ellen@ritterpharma.com
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