Ritter Pharmaceuticals Announces Lactose Intolerance Treatment,
RP-G28, Demonstrated Efficacy and Clinically Meaningful Benefit in
Phase 2b/3 Clinical Trial
LOS ANGELES, CA-(Marketwired - Mar 28, 2017) - Ritter
Pharmaceuticals, Inc. (NASDAQ: RTTR)
- Data Supports Further Clinical Development into Phase 3
- Conference call and webcast at 9 a.m. EDT, March 29,
2017
Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company")
today announced topline findings from its Phase 2b/3 study designed
to evaluate RP-G28 in subjects with lactose intolerance. Results
from the 377-subject trial show a clinically meaningful benefit to
subjects in the reduction of lactose intolerance symptoms across a
variety of outcome measures. The majority of analyses showed
positive outcome measures and the robustness of the data point to a
clear drug effect. Based on these trial results, the Company
believes that the successful completion of a confirmatory Phase 3
program could be adequate to support a New Drug Application (NDA)
submission and therefore has requested an end-of-Phase 2 meeting
with the U.S. Food and Drug Administration (FDA).
About the Trial and RP-G28
The Phase 2b/3, multi-center, randomized, doubled-blind,
placebo-controlled, parallel-group study 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 pre-specified primary endpoint
was the proportion of subjects who were abdominal symptom
responders comparing the two active dose groups combined versus
placebo using a two-sided test at the alpha=0.05 level of
significance. An abdominal symptom responder represents a
clinically meaningful reduction, defined, as a subject showing
lessening of a composite symptom score comprised of abdominal pain,
abdominal cramping, abdominal bloating and gas movement.
Primary Endpoint
The primary endpoint established in this trial focused on
defining and best quantifying a clinically meaningful benefit to
patients suffering from lactose intolerance to support product
approval and labeling claims. This endpoint was discussed with the
FDA in a Type C informational meeting prior to un-blinding the data
and incorporates the agency's recommendations.
Topline Trial Results
The primary endpoint met statistical significance, in which 40%
of the pooled dosing group and 26% of the placebo group responded
(p=0.0159). Because the primary analysis was statistically
significant, the primary endpoint comparison between the high dose
group and the placebo group was then tested and also met
statistical significance. This endpoint compared the high dose
group, of which 38% of whom were treatment responders compared to
the placebo group of which 26% of whom were treatment responders
(p=0.0294). The comparison between the low dose group and the
placebo group further met statistical significance (p=0.0434). Due
to significant irregularities demonstrated at one study center, the
data from this center were excluded from the primary analysis
population (n=296). The Company is continuing to examine this
site's significant differences from the other clinical centers.
In the entire study population taking at least one dose of drug
(n=368), including the excluded center, the comparison between the
pooled treatment groups and the placebo group narrowly missed
statistical significance (p=0.0618), in which 40% of the pooled
treatment group responded compared to 31% of the placebo group.
Both low dose and high dose group arms demonstrated a higher
proportion of responders than the placebo group.
No significant adverse events (SAEs) were reported from
treatment. Safety measurements showed no difference between
treatment and placebo patients.
Additional Study Findings
- Consistent treatment benefit of RP-G28 compared to placebo was
seen in key individual symptoms (abdominal pain, cramping,
bloating, gas, bowel urgency and composite abdominal symptoms) both
immediately post-dosing and 30-days post-dosing. These reductions
in symptoms demonstrate improved lactose tolerance and 30-days of
durability of treatment effect.
- Global patient assessment tools report consistent 30-day
durability of treatment benefit, demonstrating that the pooled
treatment groups reported statistically significant greater
positive responses compared to the placebo group when asked about
the following questions: "satisfaction with the ability of the
study medication to prevent or treat your lactose intolerance
symptoms" (PASI), improvement in "overall severity of your lactose
intolerance symptoms" (PGIS) and "adequate relief from your lactose
intolerance symptoms" (PAARI).
|
|
|
|
|
Global Assessment Tool
|
|
All Sites (Excluding Irregular Center)
|
|
All Sites
|
Patient Assessment of Satisfaction (PASI)
|
|
p=0.0035*
|
|
P=0.009*
|
Patient Global Impression of Severity (PGIS)
|
|
p=0.0032*
|
|
p=0.031*
|
Patient Assessment of Adequate Relief (PAARI)
|
|
p=0.042*
|
|
p=0.063
|
*= Statistical Significance
|
|
|
|
|
To fully explore meaningfulness of treatment benefits, a number
of additional endpoints and analyses are under further review,
including gut microbiome outcomes.
William Sandborn, M.D., Chief, Division of Gastroenterology at
University of California San Diego comments, "I believe the
totality of the results and the multitude of positive outcome
measures demonstrates there is a clear treatment benefit for
subjects taking RP-G28. The responder composite score instrument,
which we worked with the FDA to establish, performed as anticipated
to best quantify and evaluate clinically meaningful treatment
benefit for lactose intolerance sufferers. This study was
groundbreaking for both its size in lactose intolerance and in its
design to identify clinically meaningful benefit to patients in the
context of an evolving regulatory framework to demonstrate
effect."
Andrew J. Ritter, Co-Founder and President of Ritter
Pharmaceuticals, "We are pleased to have completed the largest
well-controlled clinical trial ever conducted in lactose
intolerance. The results put us one step closer to developing the
first FDA approved treatment for lactose intolerance, a significant
condition of unmet need suffered by over 40 million in the U.S. and
millions more worldwide."
Path Forward
The Company plans to discuss the study results, including the
irregularities identified at one of the study centers, and design
of a confirmatory Phase 3 study plan with the FDA at an upcoming
End-of-Phase 2 meeting. Based on consistency of results, the
company believes that the successful completion of a confirmatory
Phase 3 program could be adequate to support a New Drug Application
(NDA) submission.
Conference Call and Webcast to Present Topline Data
The Company, including William Sandborn, M.D., Chief, Division
of Gastroenterology at University of California San Diego, will be
holding a conference call on Wednesday, March 29, 2017 at 9 a.m.
EDT / 6 a.m. PDT to present the topline clinical trial results. The
dial-in numbers are 1-877-459-3964 for domestic callers and
1-412-902-1023 for international callers. The conference ID number
for both is 13658728. A live webcast of the conference call will
also be available by clicking here (http://bit.ly/2nuL7c6) and
logging in.
After the live webcast, the event will remain archived on
Ritter's website. A telephone replay of the call will be available
until April 12, 2017. The replay dial-in numbers are 1-844-512-2921
for domestic callers and 1-412-317-6671 for international callers.
Please use event passcode 13658728.
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
Ritter Pharmaceuticals (NASDAQ:RTTR)
Historical Stock Chart
From Aug 2024 to Sep 2024
Ritter Pharmaceuticals (NASDAQ:RTTR)
Historical Stock Chart
From Sep 2023 to Sep 2024