Galapagos reports positive topline results with selective TYK2 inhibitor GLPG3667 in Phase 1b psoriasis study
July 14 2021 - 4:01PM
- Generally safe and well tolerated
- Positive efficacy signal in psoriasis
patients at Week
4
- 40% of patients
showed improvement of at
least 50% in PASI response
(PASI 50) with
high dose of GLPG3667 at
Week 4
- Data support initiation of Phase
2b dose finding
study in psoriasis
Mechelen, Belgium;
14 July
2021;
22.01
CET; regulated
information - Galapagos
NV (Euronext &
Nasdaq:
GLPG) reports
positive topline results
with tyrosine kinase 2
(TYK2) inhibitor
GLPG3667 in a Phase 1b
study in psoriasis
patients. GLPG3667 was discovered
by Galapagos.
Galapagos evaluated GLPG3667, a proprietary
selective TYK2 compound, in a randomized, placebo-controlled,
double-blind Phase 1b study in 31 patients with diagnosis of
moderate to severe plaque psoriasis. Patients were randomized in a
1:1:1 ratio to a daily oral dose of GLPG3667 (low dose or high
dose) or placebo, for a total of four weeks. Main objectives were
to evaluate the safety and tolerability of GLPG3667 as well as
signs of clinical activity at Week 4.
GLPG3667 was well tolerated in this Phase 1b
trial. One patient in the low dose group interrupted the study for
one day for exacerbation of psoriasis. The majority of treatment
related adverse events (AEs) were mild in nature and transient.
There were no deaths or serious adverse events (SAEs) in this
4-week study. At Week 4, four out of 10 patients in the high dose
group had a PASI1 50 response, defined as at least a 50%
improvement in PASI from baseline, compared to one out of 10
subjects on placebo. There were no subjects with a PASI 50 response
on the low dose of GLPG3667. The four responders in the high dose
group of GLPG3667 achieved a 52%, 65%, 74% and 81% improvement
respectively in their PASI scores from baseline, while the subject
randomized to placebo improved by 52%. Positive efficacy signals
were also observed with the high dose for other endpoints,
including affected Body Surface Area and physician and patient
global assessment, versus placebo at Week 4.
“We are pleased with the efficacy signal and
safety profile observed with GLPG3667 in patients with psoriasis
over a 4-week period,” said Dr. Walid Abi-Saab, Chief Medical
Officer of Galapagos. “Based on these results, we aim to initiate a
global Phase 2b program in psoriasis next year as part of a program
to develop our selective oral TYK2 inhibitor GLPG3667 broadly in
inflammatory indications.”
“The PASI 50 scores and other efficacy data
after only four weeks of treatment, combined with the safety
profile observed, are very supportive for moving this compound into
a larger trial in psoriasis. People living with psoriasis remain in
need of alternative treatments, especially oral ones,” said Prof.
Dr. Diamant Thaci, Professor of Medicine at the Comprehensive
Center for Inflammation Medicine, University of Lübeck,
Germany.
Galapagos intends to submit study outcomes with
GLPG3667 for publication at scientific conferences and in
peer-reviewed medical journals.
GLPG3667 is an investigational drug and not
approved by any regulatory authority. Its efficacy and safety have
not been established.
About GalapagosGalapagos NV
discovers and develops small molecule medicines with novel modes of
action, several of which show promising patient results and are
currently in clinical development in multiple diseases. Our
pipeline comprises discovery through to Phase 3 programs in
inflammation, fibrosis, 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.
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).
ContactsInvestors:Elizabeth
GoodwinVP Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143 ir@glpg.com
Media:Kyra ObolenskySenior Director Corporate
Communications+32 491 92 64 35
Evelyn FoxDirector Executive Communications+31 65 3591
999communications@glpg.com
Galapagos 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 risk that ongoing and future
clinical studies with GLPG3667 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
GLPG3667 due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties and that Galapagos’
estimations regarding its GLPG3667 development program and
regarding the commercial potential of GLPG3667, 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 2020 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.
1 Psoriasis Area and Severity Index; index used to express
the severity of psoriasis. It combines the severity (erythema,
induration and desquamation) and percentage of affected area
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