Galapagos and Servier report topline results for ROCCELLA Phase 2 clinical trial with GLPG1972/S201086 in knee osteoarthritis...
October 15 2020 - 4:19PM
Mechelen, Belgium and Paris, France, 15
OCTOBER 2020, 22.01 CET; regulated information –Servier and
Galapagos NV (Euronext & NASDAQ: GLPG) report that no signal of
activity was observed in the topline results in their ROCCELLA
Phase 2 trial with GLPG1972/S201086.
ROCCELLA is a global, double-blind,
placebo-controlled, dose ranging trial evaluating the efficacy and
safety of three different once-daily oral doses of GLPG1972/S201086
in 932 patients with knee osteoarthritis (OA) over 52 weeks of
treatment. The study population was aged between 40 to 76 years
(mean age was 63), mainly female (70%), and with a mean disease
duration of 7 years.
The primary objective of ROCCELLA was to
demonstrate the efficacy of at least one dose of GLPG1972/S201086
compared to placebo after 52 weeks of treatment in reducing
cartilage loss of the central medial tibiofemoral compartment of
the target knee via quantitative MRI.
The trial failed to meet the primary objective.
The change from baseline to week 52 in cartilage thickness, in mm
(SD) was -0.116 (0.27) for the placebo group and -0.068 (0.20),
-0.097 (0.27) and -0.085 (0.22), for the low, medium and high dose,
respectively. Statistically significant difference versus placebo
was not reached in any of the treated groups.
There was no significant difference compared to
placebo observed on secondary endpoints, including clinical
outcomes.
Additional analyses are being conducted to fully
evaluate the results, which will be presented at upcoming medical
conferences.
GLPG1972/S201086 was generally well-tolerated by
patients in this Phase 2 trial.
“While we are disappointed that ADAMTS-5
inhibition by GLPG1972/S201086 proved not to make a difference in
this trial, we want to express our gratitude to all participating
patients and investigators. This study result, while not what we
hoped for, does add to the body of knowledge to help fight OA, a
disease with substantial unmet medical need,” said Dr. Walid
Abi-Saab, Chief Medical Officer of Galapagos.
“We are pleased to have performed this study
with Galapagos. Unfortunately, the ROCCELLA results provided
insufficient evidence of GLPG1972/S201086 efficacy in patients with
knee osteoarthritis. We acknowledge the importance of assessing
this innovative mechanism of action in the clinical setting and we
will continue analyzing the data for better knowledge of the
disease for the benefit of the patients and for future
developments. We would like also to thank all patients and
investigators for participating in this very important study,” said
Dr. Patricia Belissa-Mathiot, Director of Clinical Development and
R&D Chief Medical Officer at Servier.
About the ROCCELLA trial
ROCCELLA was a multi-regional, randomized,
double-blind, placebo-controlled, dose ranging trial evaluating the
efficacy and safety of three different once-daily oral doses of
GLPG1972/S201086 in patients with knee osteoarthritis. ROCCELLA
included 932 patients in 12 countries in Europe, Asia, North and
South America. Galapagos was responsible for ROCCELLA in the United
States, where 326 patients were recruited. Servier was responsible
for this trial in 11 countries, where 606 patients were
recruited.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG)
discovers and develops 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, osteoarthritis and other indications. Our
ambition is to become a leading global biopharmaceutical company
focused on the discovery, development and commercialization of
innovative medicines. More information at www.glpg.com.
About Servier
Servier is an international pharmaceutical
company governed by a non-profit foundation, with its headquarters
in France (Suresnes). With a strong international presence in 150
countries and a total revenue of 4.6 billion euros in 2019, Servier
employs 22,000 people worldwide. Entirely independent, the Group
invests on average 25% of its total revenue (excluding generics)
every year in research and development and uses all its profits for
its development. Corporate growth is driven by Servier’s constant
commitment in five areas of excellence: cardiovascular,
immune-inflammatory, and neurodegenerative diseases, oncology and
diabetes, as well as by its activities in high-quality generic
drugs. Servier also offers eHealth solutions beyond drug
development. More information: www.servier.com.
Contacts Galapagos
Investor contacts Galapagos:Elizabeth GoodwinVP
IR+1 781 460 1784 Sofie Van GijselSenior Director IR +32 485
19 14 15ir@glpg.com |
Media contacts Galapagos:Carmen VroonenGlobal Head
of Communications & Public Affairs+32 473 82 48 74 Anna
GibbinsSenior Communications Director - Therapeutic Areas +44 7717
801900 communications@glpg.com |
Contacts Servier:
Media Relations:
Sonia Marques
: presse@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28
76 13 Jean-Clément Vergeau : presse@servier.com – Tel. +33
(0)1 55 72 46 16 / +33 (0)6 79 56 75 96
Galapagos 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 risk that ongoing and future
clinical studies with GLPG1972/S201086 may not be completed in the
currently envisaged timelines or at all, the inherent uncertainties
associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs may not support registration or further development of
GLPG1972/S201086 due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties (including
our collaboration partner for GLPG1972/S201086, Servier) and that
Galapagos’ estimations regarding its GLPG1972/S201086 development
program and regarding the commercial potential of GLPG1972/S201086,
may be incorrect, 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.
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).
- Galapagos and Servier report topline results for ROCCELLA Phase
2 clinical trial with GLPG1972 S201086 in knee osteoarthritis
patients
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