Current Report Filing (8-k)
2017年3月14日 - 6:26AM
Edgar (US Regulatory)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): March 1, 2017
RITTER
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-37428
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26-3474527
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(State
or other
jurisdiction
of incorporation)
|
|
(Commission
File
Number)
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|
(I.R.S.
Employer
Identification
No.)
|
1880
Century Park East, Suite 1000
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|
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Los
Angeles, California
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90067
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code:
(310) 203-1000
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (
see
General Instruction A.2. below):
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[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item
7.01.
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Regulation
FD Disclosure.
|
On
March 1, 2017, Ritter Pharmaceuticals, Inc. (the “Company”) held a Type C informational meeting with the U.S. Food
and Drug Administration (the “FDA”) to discuss its development plans and its current Phase 2b/3 clinical trial
for the treatment of lactose intolerance per earlier discussions with the FDA. The focus of the meeting was to gain feedback about
the Company’s statistical analysis plan (“SAP”) and to best position the SAP so that the study may be
considered a pivotal registration trial upon receipt of positive results. This meeting was held prior to un-blinding the
Company’s Phase 2b/3 data.
The
meeting with the FDA was constructive, collaborative and productively focused on best defining clinically meaningful benefits
to patients suffering from lactose intolerance and how to reflect these benefits in endpoints. By addressing the FDA’s recent
recommendations, the Company has chosen to modify aspects of its SAP, including modifying its primary endpoint to combine
abdominal pain with relevant secondary endpoints to establish an abdominal composite score (abdominal pain, abdominal cramping,
abdominal bloating and abdominal gas). The protocol design and the assessment utilized to collect lactose intolerance symptoms
remain unchanged. The Company is moving forward to make these SAP changes, un-blind the data and release top-line results
from the clinical trial in the coming weeks.
The
Company believes these modifications will be better suited to show clinical meaningfulness to patients and better support product
approval and labeling claims to address the FDA’s recent recommendations.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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RITTER
PHARMACEUTICALS, INC.
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By:
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/s/
Michael D. Step
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Name:
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Michael
D. Step
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Title:
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Chief
Executive Officer
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Date:
March 13, 2017
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