GALAPAGOS REPORTS PRIMARY ENDPOINT FOR THE ONGOING FILGOTINIB MANTA AND MANTA-RAy SAFETY STUDIES
March 04 2021 - 1:49AM
GALAPAGOS REPORTS PRIMARY ENDPOINT FOR THE ONGOING FILGOTINIB MANTA
AND MANTA-RAy SAFETY STUDIES
- 8.3% patients on placebo and 6.7% patients on
filgotinib had a 50% or more decline in sperm concentration at week
13
- No new safety findings were identified
- Data will be submitted to the relevant regulatory
authorities
Mechelen, Belgium, 4 March 2021, 07.40
CET, regulated information –Galapagos NV (Euronext & Nasdaq:
GLPG) today announced interim results from MANTA and MANTA-RAy, two
ongoing safety studies investigating the effect of Jyseleca®
(filgotinib) on sperm parameters in males with inflammatory bowel
disease (MANTA) or rheumatic conditions (MANTA-RAy).
In total, 248 patients were randomized 1:1 to
receive filgotinib 200 mg once daily or placebo for an initial
13-week, double-blind treatment period. The primary endpoint in
both trials was the proportion of patients who had a reduction of
50% or more in sperm concentration at Week 13. Patients who met
this endpoint discontinued study treatment at Week 13, were
switched to standard of care treatment and were monitored for
reversibility every 13 weeks for up to 52 weeks.
Out of the 248 randomized patients, 240 reached
Week 13 with two evaluable semen samples at baseline and Week 13.
Of those, 18 patients showed a ≥50% decline in sperm concentration,
with 10/120 (8.3%) patients on placebo and 8/120 (6.7%) patients on
filgotinib. These studies, which were designed with the input of
the relevant health authorities, are not powered for statistical
comparison between groups. These data will now be submitted to
relevant regulatory authorities.
Beyond the double-blind, placebo-controlled,
13-week period, for which MANTA and MANTA-RAy results are pooled,
patients who did not meet the primary endpoint of 50% or more
decline in sperm motility or morphology could continue under their
respective trial protocol on blinded treatment, receive open-label
filgotinib or receive standard of care therapy based on disease
response, for another 13 weeks before entering a long-term
extension period. At any point, patients exhibiting a predetermined
sperm decline enter a monitoring phase in which they are assessed
every 13 weeks for reversibility for up to 52 weeks.
As the MANTA and MANTA-RAy trials are ongoing,
and to maintain data integrity, Galapagos and Gilead intend to
report additional results only after all patients in the monitoring
phase have completed the protocol-defined observation period.
“We are pleased the interim results reported
today will be submitted to the relevant regulatory authorities,”
said said Dr. Walid Abi-Saab, CMO of Galapagos.
When the MANTA and MANTA-RAy trials are
completed, Galapagos and Gilead intend to submit the full results
for publication in a peer-reviewed medical journal.
About filgotinib Filgotinib is
approved and marketed as Jyseleca (200 mg and 100 mg tablets) in
Europe, Great Britain and Japan for the treatment of adults with
moderately to severely active RA who have responded inadequately or
are intolerant to one or more disease modifying anti-rheumatic
drugs (DMARDs). Filgotinib may be used as monotherapy or in
combination with methotrexate (MTX). The European Summary of
Product Characteristics for filgotinib, which includes
contraindications and special warnings and precautions, is
available at www.ema.europa.eu. The interview form from the
Japanese Ministry of Health, Labour and Welfare is available at
www.info.pmda.go.jp. Filgotinib was submitted to the European
Commission for an extended indication for the treatment of adults
with moderately to severely active ulcerative colitis who have had
an inadequate response with, lost response to, or were intolerant
to either conventional therapy or a biologic agent.
With the exception of filgotinib's approval for the treatment of
RA by the European Commission and Japanese Ministry of Health,
Labour and Welfare, all of our drug candidates are investigational;
their efficacy and safety have not been fully evaluated by any
regulatory authority and they are not yet approved for any use
outside of clinical trials.
About the MANTA and MANTA-RAy
StudiesMANTA is a Phase 2 safety study being conducted by
Gilead in men with moderate/severe active ulcerative colitis (UC)
or Crohn’s disease (CD) to assess semen parameters while taking
filgotinib. MANTA-RAy is a similar study being conducted by
Galapagos outside the US, in men with rheumatic diseases. The
results of both studies have been pooled in the interim results of
the primary endpoint.
About Galapagos Galapagos NV
discovers, develops and commercializes small molecule medicines
with novel modes of action, several of which show promising patient
results and are currently in late-stage development in multiple
diseases. Our pipeline comprises discovery through Phase 3 programs
in inflammation, fibrosis and other indications. Our ambition is to
become a leading global biotech company focused on the discovery,
development and commercialization of innovative medicines. More
information at www.glpg.com.
This press release contains inside information
within the meaning of Regulation (EU) No 596/2014 of the European
Parliament and of the Council of 16 April 2014 on market abuse
(market abuse regulation).
Forward-looking statementsThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, that are subject to risks, uncertainties and other factors
that could cause actual results to differ materially from those
referred to in the forward-looking statements and, therefore, the
reader should not place undue reliance on them. These risks,
uncertainties and other factors include, without limitation, the
inherent risks associated with clinical trial and product
development activities, competitive developments, and regulatory
approval requirements, including the risk that data from the
ongoing and planned clinical research programs (including but not
limited to the data from the up to 52 weeks monitoring phase of the
MANTA and MANTA-RAy trials) with filgotinib may not support
registration or further development due to safety, efficacy or
other reasons, the timing or likelihood of additional regulatory
authorities approval of marketing authorization for filgotinib,
such additional regulatory authorities requiring additional
studies, Galapagos’ reliance on collaborations with third parties,
including the collaboration with Gilead for filgotinib, the
uncertainty regarding estimates of the commercial potential of
filgotinib, the timing of and the risks related to completing and
implementing the amendment of our arrangement with Gilead for the
commercialization and development of Jyseleca (filgotinib), as well
as those risks and uncertainties identified in our Annual Report on
Form 20-F for the year ended 31 December 2019 and our subsequent
filings with the SEC. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The forward-looking statements contained herein are
based on management’s current expectations and beliefs and speak
only as of the date hereof, and Galapagos makes no commitment to
update or publicly release any revisions to forward-looking
statements in order to reflect new information or subsequent
events, circumstances or changes in expectations.
Contacts
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+32 485 19 14
15ir@glpg.com
Media:Evelyn FoxCommunications & Public
Affairs+31 653 591 999
Anna GibbinsSenior Director Therapeutic Areas Communications+44
7717 801900communications@glpg.com
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