Report of Foreign Issuer (6-k)
January 16 2018 - 8:31AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of:
January 2018 (Report
No.1)
Commission file number:
001- 38041
THERAPIX BIOSCIENCES LTD.
(Translation of registrant’s name
into English)
4 Ariel Sharon Street
HaShahar Tower, 16th Floor
Givatayim 5320047, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
Update
on Request to FDA for Orphan Drug Designation for THX-TS01 for
Treatment
of Tourette Syndrome
With respect to our submission
during June 2016 of a request for orphan drug designation to the FDA for THX-110 for the treatment of Tourette Syndrome, and with
respect to a letter dated September 29, 2016, we have on September 27, 2017 responded to the above mentioned FDA letter within
the designated time frames, and provided the FDA with our articulated and reasoned responses including documentation and clinical
data to supports it. On December 26, 2017, we received FDA’s response to our response. The FDA has accepted that there is
adequate scientific rationale for the treatment of TS with the THX-110 mainly through the preliminary results of ongoing clinical
trial, suggesting that THX-110 may provide benefit in treating Tourette Syndrome. However, the FDA indicated that we did not provide
adequate prevalence estimates, and any evidence to support our statement that only moderate to severe Tourette's patients would
require pharmacological treatment.
Based on the above, the
FDA was unable to grant us our request. We intend to respond promptly and provide the missing information. There is no assurance
that we will successfully obtain orphan drug designation for Tourette Syndrome, although we believe that we can provide adequate
data to address all issues raised by the FDA.
SIGNATURES
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, thereunto duly
authorized.
|
Therapix Biosciences Ltd.
(Registrant)
|
|
|
|
|
By
|
/s/ Ascher Shmulewitz
|
|
Name:
|
Ascher Shmulewitz, M.D, Ph.D.
|
|
Title:
|
Chief Executive Officer
|
Date: January 16, 2018
2
Therapix Biosciences (NASDAQ:TRPX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Therapix Biosciences (NASDAQ:TRPX)
Historical Stock Chart
From Apr 2023 to Apr 2024