- 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
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.
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
With the exception of filgotinib's approval for the treatment of RA by the
About the MANTA and MANTA-RAy Studies
MANTA 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
This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the
Forward-looking statements
This 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
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