Ritter Pharmaceuticals Reports Microbiome Data from Phase 2b Study of RP-G28 Promotes Beneficial Adaptation of the Gut Microb...
2018年3月12日 - 7:00PM
Ritter Pharmaceuticals, Inc. (NASDAQ:RTTR) (“Ritter
Pharmaceuticals” or the “Company”), a developer of novel
therapeutics that modulate the gut microbiome to treat
gastrointestinal diseases with an initial focus on the development
of the first FDA-approved treatment for lactose intolerance,
announced today that its lead drug, RP-G28, promoted beneficial
adaptation of the gut microbiome in its Phase 2b study of 377
lactose intolerance patients.
In a report prepared by Andrea Azcarate-Peril, Ph.D., Associate
Professor of Medicine at University of North Carolina at Chapel
Hill, RP-G28 modified the relative abundance of 28 bacterial
species. Specifically, a dramatic increase in species of
Bifidobacterium was observed, including some known to metabolize
lactose. The understood mechanism of action of RP-G28 for
mitigating lactose intolerance symptoms is by increasing
lactose-metabolizing bacteria in the colon that compensate for the
deficit of endogenous lactase activity. These beneficial bacteria
remove the undigested lactose found in dairy products from the gut
thus reducing the gas production and water retention that produce
lactose intolerance symptoms.
“These findings are consistent with the Phase 2a clinical data
of RP-G28 for the treatment of lactose intolerance,” commented Dr.
Azcarate-Peril. “During the Phase 2a study, we observed an increase
in bifidobacteria, which were confirmed in this larger Phase 2b
study. This is significant since Bifidobacterium have proven health
benefits for both the gastrointestinal tract and the immune
system.”
Key findings of the study’s microbiome data include the
following:
- Treatment with RP-G28 resulted in a beneficial adaptation of
the microbiome and a significant impact on the abundance of 28
bacterial species.
- High-throughput quantitative polymerase chain reaction (qPCR)
data showed a clear and significant increase in the relative
abundance of the phylum Actinobacteria, family Bifidobacteriaceae,
genus Bifidobacterium and family Lactobacillaceae after 30 days of
treatment, in both groups of RP-G28 treated patients, but not in
the placebo group. Specifically, abundances of B. angulatum, B.
gallicum, B. longum, B. bifidum, B. breve, and B. catenulatum were
increased by treatment with RP-G28.
- Actinobacteria of the family Bifidobacteriaceae increased in a
higher proportion of treated patients. Bifidobacteria increased in
77.7% (77/99) of individuals in the treatment group compared to
52.1% (49/94) in the placebo group (p=<.001), correlating with a
similar trend reflected in the Phase 2a data.
- Pediococcus, species of the Lactobacillales order,
Enterococcaceae, and Delftia were increased in clinical responders
after days 30 of treatment in both low and high dose patient
groups.
“These results confirm an effective mode of action for RP-G28
and further support the therapeutics’ potential for use in other
indications,” added Andrew J. Ritter, co-founder and president of
Ritter Pharmaceuticals, Inc. “As we move forward with our Phase 3
clinical trial of RP-G28 for the treatment of lactose intolerance
in Q2 2018, we will consider how these findings can make a positive
impact for patients beyond lactose intolerance in other
indications.”
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com,
@RitterPharma) develops novel therapeutic products that modulate
the gut microbiome to treat gastrointestinal diseases. The
Company’s lead product, RP‐G28, has the potential to become the
first FDA‐approved treatment for lactose intolerance, a condition
that affects millions worldwide. RP-G28 has been studied in Phase 2
trials and is now in Phase 3 clinical development. 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 press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements refer to future plans and
expectations, including statements regarding the timing of our
first Phase 3 pivotal clinical trial. 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. Factors that could affect the
Company’s actual results are included in the Company’s SEC filings,
including the Company’s most recent reports on Form 10-K and 10-Q
filed with the SEC. These forward-looking statements are made only
as of the date hereof, and, except as required by law, the Company
undertakes no obligation to update or revise its forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts Investor Contact:Jeffrey Benjamin
310-203-1000 jeffrey@ritterpharma.com
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