Ritter Pharmaceuticals, Inc. Announces End of Phase 2 Meeting with the FDA and Initiates Phase 3 Program Development Activiti...
2017年4月12日 - 11:00PM
Marketwired
Ritter Pharmaceuticals, Inc. Announces End of Phase 2 Meeting
with the FDA and Initiates Phase 3 Program Development
Activities
LOS ANGELES, CA--(Marketwired - Apr 12, 2017) - Ritter
Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company") today, April
12, 2017, announced that the U.S. Food and Drug Administration
(FDA) has agreed to schedule an end of phase 2 meeting with the
company which is expected to take place in the third quarter of
2017. The Company plans to discuss the results of its recently
completed phase 2b/3 trial and phase 3 plans in preparation of a
New Drug Application (NDA) submission of RP-G28 for the treatment
of lactose intolerance. The completed phase 2b/3 trial demonstrated
several positive topline results and full analysis of the data is
underway. The trial was the largest well-controlled clinical study
ever conducted in lactose intolerance.
Topline phase 2b/3 trial results provide several positive
outcomes(1):
- RP-G28 showed a clinically meaningful beneficial effect on
patients in both symptom reduction and global patient assessments
of benefit.
- In consultation with the FDA(2), a composite symptom score was
considered appropriate for the primary endpoint. The trial's
associated outcomes data support the primary endpoint as an
appropriate measurement tool to evaluate and quantify clinically
meaningful patient benefit (as defined as a composite symptom
reduction of abdominal pain, abdominal cramping, abdominal
bloating, and abdominal gas).
- No serious adverse events (SAEs) related to RP-G28 were
reported in the study, further supporting the safety profile
previously shown in the phase 2a study.
- The trial evaluated two different dosing strengths, generating
the necessary data to help identify an optimal dose regimen of
treatment effect.
Dr. William Chey, Director of the GI Physiology Laboratory at
University of Michigan, commented, "The fact that the Company was
able to develop a well-defined clinical outcomes instrument to
quantify clinical meaningfulness in lactose intolerance patients is
an important outcome of the trial and contribution to the field. We
need to remember, there was no standard test to evaluate lactose
intolerance symptoms prior to this study. Based on the topline
results of the study, I believe this instrument performed well in
defining and capturing clinical benefits to patients with lactose
intolerance. I am encouraged to see consistency in the data outcome
measures and believe that the topline results provide data
supporting a treatment benefit of this investigational compound."
Dr. Chey further noted, "Based upon these encouraging results, I
believe a Phase 3 program can be well-defined and developed from
here."
(1) Additional topline data results of the phase 2b/3 trial can
be found at
www.ritterpharmaceuticals.com/investors/events-presentations (2)
Ritter Pharmaceuticals held a Type C informational meeting with the
FDA in March of 2017 prior to unblinding the phase 2b/3 clinical
trial
End of Phase 2 Meeting & Phase 3 Program Plans The end of
phase 2 meeting will be an important venue to consult with the FDA
on finalizing the Phase 3 clinical program and remaining
NDA-enabling package necessary for obtaining commercial approval of
RP-G28 for the treatment of lactose intolerance. The Company
further plans to discuss many aspects of the phase 2b/3 trial
results, including the use of the phase 2b/3 data as supportive for
registration and the number of subjects expected in the remaining
clinical program for a satisfactory NDA filing.
In preparation for the Phase 3 program, the Company has
commenced manufacturing efforts and currently anticipates the
initiation of phase 3 in the first half of 2018.
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, risks that the FDA will not agree
with our interpretation of the data results from our phase 2b/3
clinical trial and 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 Information
- Contact Ellen Mochizuki 310-203-1000
ellen@ritterpharma.com
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