Report of Foreign Issuer (6-k)
March 20 2018 - 8:32AM
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:
March 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):_____
Therapix
Biosciences Announces FDA Clearance of Investigational New Drug (IND) for Phase IIa Clinical Trial of THX-110 in the Treatment
of Chronic Low Back Pain
Therapix
Biosciences Ltd. (the “Company”) announced on March 20, 2018 that the U.S. Food and Drug Administration has cleared
its Investigational New Drug application (IND) for THX-110 in the treatment of Chronic Low Back Pain. The Company expects to commence
a Phase IIa Clinical Trial titled "Examining the Efficacy of THX-110 [Dronabinol (synthetic Δ9-tetrahydracannabinol)
and Palmitoylethanolamide (PEA)] for Chronic Low Back Pain" during the second quarter of 2018. The Phase IIa Clinical Trial
is a single-arm, open-label trial, in which each subject receives one daily treatment of the drug via oral administration and
is followed-up for a period of 6 weeks with an additional 2 weeks follow up after the last study treatment. Approximately 20 subjects
are expected to participate and receive the drug in the context of the Clinical Trial at the Comprehensive Research Institute
(CRI) in Hendersonville, TN, U.S.A. The primary endpoint of the Clinical Trial is to prove the safety, tolerance and efficacy
of THX-110 in the treatment of adult patients suffering from chronic low back pain, with efficacy measured by the improvement
of quality of life outcomes.
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:
March 20, 2018
2
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