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
of the Securities Exchange Act of 1934
For the month of January, 2016
Commission File Number: 000-36000
XTL Biopharmaceuticals Ltd.
(Translation of registrant’s name
into English)
5 HaCharoshet St.,
Raanana 4365603
Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will
file annual reports under cover Form 20-F or Form 40-F.
Form
20-F x Form
40-F ¨
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
Incorporation by Reference: This Form 6-K of XTL Biopharmaceuticals
Ltd. is hereby incorporated by reference into the registration statements on Form S-8 (File No. 333-148085, File No. 333-148754
and File No. 333-154795) and Form F-3 (File No. 333-194338).
XTL
BIOPHARMACEUTICALS announces encouraging feedback from U.S. FDA on its upcoming ind filing for lUPUS drug hcdr1
Successful outcome of FDA
guidance includes BILAG as the primary efficacy endpoint, patient inclusion criteria, and patient population for safety requirements
for marketing approval
RAANANA,
Israel- (January 25, 2016) – XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB) (“XTL”
or the “Company”), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus,
today announced the Company has received written guidance from the U.S. Food and Drug Administration (FDA) in response to a pre-investigational
new drug (IND) meeting package regarding its upcoming IND filing for its drug candidate, hCDR1. Based on the FDA’s response,
XTL plans to file its IND, and in the coming quarters initiate a global clinical trial for hCDR1 in the treatment of systemic lupus
erythematosus (SLE) in the U.S., Europe and Israel.
The FDA provided encouraging guidance on
several key aspects of XTL’s proposed clinical trial including: the primary efficacy endpoint to be based on the BILAG index,
a measure of lupus disease activity which was the secondary efficacy endpoint in a prior Phase 2 study of hCDR1; the appropriate
patient population; and total number of patients required to prove safety for a new drug application (NDA) for marketing approval.
The FDA recommended that the trial be a Phase 2 study. The FDA has also provided additional guidance on other aspects of the trial
design, which XTL intends to review with its Clinical Advisory Board as it finalizes the study protocol including doses and study
duration.
“We are very pleased with the FDA’s
written response to our pre-IND filing meeting package and see it as a vote of confidence in our ability to bring a much needed
treatment to people living with lupus,” stated Josh Levine, Chief Executive Officer of XTL.
“This study has an increased likelihood
to succeed, in our view, because the FDA’s guidance encourages the study to be substantially similar to the prior Phase 2
trial which demonstrated efficacy in the 0.5 mg dose using the BILAG index, the secondary endpoint of that trial. We believe the
FDA’s guidance validates the value and relevance of the safety and efficacy data from the prior Phase 2 trial including data
on the patient population and statistically significant effect of a 0.5mg dose of hCDR1 on the BILAG endpoint. Using a primary
efficacy endpoint based on the BILAG index, we are hopeful that our upcoming study will produce robust data towards supporting
a future NDA filing,” Levine added.
About hCDR1
hCDR1 is a novel compound with a unique
mechanism of action and with clinical data on over 400 patients in 3 clinical studies. The drug has a favorable safety profile,
is well tolerated by patients and has demonstrated efficacy in at least one and possibly more clinically meaningful endpoints.
For more information please see a peer reviewed article in Lupus Science and Medicine journal (http://lupus.bmj.com/content/2/1/e000104.full).
XTL Biopharmaceuticals Ltd.
5 Hacharoshet Street, Raanana, 43656, Israel
Tel: +972 9 955 7080;
email: ir@xtlbio.com
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving
many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system and others. The
biologic basis of the disease is a defect in the immune (defense) system, leading to production of self (auto) antibodies, attacking
the normal organs and causing irreversible damage. According to the Lupus Foundation of America, at least 1.5 million Americans
have the disease (more than 5 million worldwide) with more than 16,000 new cases diagnosed each year. The majority of patients
are women of childbearing years. There has been only one drug approved by the FDA in the last over 50 years and recently two of
the few drugs in advanced development did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd.
(XTL)
XTL Biopharmaceuticals
Ltd., is a clinical-stage biotech company focused on the development of pharmaceutical products for the treatment of autoimmune
diseases including lupus. The Company’s lead drug candidate, hCDR1, is a world-class clinical asset for the treatment of
systemic lupus erythematosus (SLE). There currently is no effective treatment on the market for SLE. hCDR1 has robust clinical
data in three clinical trials with 400 patients and over 200 preclinical studies with data published in more than 40 peer
reviewed scientific journals. Based on safety and efficacy data shown in a completed Phase 2 study, the Company expects to
initiate a Phase 2 trial in 2016.
XTL is traded
on the Nasdaq Capital Market (NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTLB). XTL shares are included in the following
indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv Tech Index.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals
Ltd.
Tel: +972 9 955 7080
Email: ir@xtlbio.com
www.xtlbio.com
Cautionary Statement
This press release may contain forward-looking
statements, about XTL’s expectations, beliefs or intentions regarding, among other things, its product development efforts,
business, financial condition, results of operations, strategies or prospects. In addition, from time to time, XTL or its representatives
have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use
of forward-looking words such as "believe," "expect," "intend," "plan," "may,"
"should" or "anticipate" or their negatives or other variations of these words or other comparable words or
by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may
be included in, but are not limited to, various filings made by XTL with the U.S. Securities and Exchange Commission, press releases
or oral statements made by or with the approval of one of XTL’s authorized executive officers. Forward-looking statements
relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements
relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause
XTL’s actual results to differ materially from any future results expressed or implied by the forward-looking statements.
Many factors could cause XTL’s actual activities or results to differ materially from the activities and results anticipated
in such forward-looking statements, including, but not limited to, the factors summarized in XTL’s filings with the SEC and
in its periodic filings with the TASE. In addition, XTL operates in an industry sector where securities values are highly volatile
and may be influenced by economic and other factors beyond its control. XTL does not undertake any obligation to publicly update
these forward-looking statements, whether as a result of new information, future events or otherwise. Please see the risk factors
associated with an investment in our ADSs or ordinary shares which are included in our Annual Report on Form 20-F as filed with
the U.S. Securities and Exchange Commission on April 28 2015.
SIGNATURES.
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
XTL
BIOPHARMACEUTICALS LTD.
Date: January 25, 2016
By: /s/ Josh Levine
Josh
Levine
Chief
Executive Officer
XTL Biopharmaceuticals (NASDAQ:XTLB)
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