Galapagos initiates Phase 1 trial for second Toledo compound
September 24 2019 - 4:01PM
Galapagos initiates Phase 1 trial for second Toledo compound
- Second generation compound of novel target class with dual
action in inflammatory disorders
- Discovered and validated on Galapagos’ target discovery
platform
Mechelen, Belgium; 24 September 2019, 22.01 CET – Galapagos
NV (Euronext & NASDAQ: GLPG) started a Phase 1 trial with
GLPG3970, a second generation compound against a novel and
undisclosed inflammation target class discovered by
Galapagos.
The Toledo platform delivers small molecule inhibitors of Toledo
targets with different selectivity profiles. GLPG3970 is a
second-generation, more selective, compound for which preclinical
activity has already been observed in a number of inflammatory
indications, including in inflammatory bowel diseases, rheumatoid
arthritis, and psoriasis.
The Phase 1 trial is a double-blind,
placebo-controlled study evaluating the efficacy, safety,
tolerability, and PK/PD1 of GLPG3970 single and multiple ascending
doses in up to 52 adult healthy male subjects, and, in a next step,
in 20 psoriasis patients.
A Phase 1 trial with our first generation Toledo
compound, GLPG3312, was announced early 2019, with results expected
early next year. The Phase 2 trial in ulcerative colitis patients
is now scheduled to start in H1 2020.
“We are excited with the rapid progress of our
second Toledo compound into the clinic,” said Dr. Piet Wigerinck,
Chief Scientific Officer at Galapagos. “With the start of this
trial, we are on track to potentially launch multiple proof of
concept studies in parallel in 2020, in a range of inflammatory
diseases. Thanks to its unique mechanism of action, the Toledo
program has the potential to become a new paradigm in the treatment
of inflammatory diseases.”
About Toledo“Toledo” is a code name for a
novel class discovered by Galapagos. The target family has a dual
mode of action on inflammation by stimulating anti-inflammatory
cytokines and inhibiting pro-inflammatory cytokines. Galapagos has
observed unprecedented activity2 in various inflammatory
preclinical models with compounds targeting the class. Galapagos is
executing on a broad program to discover and develop multiple
series of compounds acting on Toledo, aimed at activity across
several inflammatory conditions.
GLPG3312 and GLPG3970 are investigational drugs
and their efficacy and safety have not been established.
For more information about Toledo in our R&D
Update 2018: www.glpg.com/webcasts.For information about the
clinical trial with GLPG3312 and GLPG3970:
www.clinicaltrials.gov.
About GalapagosGalapagos (Euronext &
NASDAQ: GLPG) discovers and develops small molecule medicines with
novel modes of action, three of which show promising patient
results and are currently in late-stage development in multiple
diseases. The company’s pipeline comprises Phase 3 through to
discovery programs in inflammation, fibrosis, osteoarthritis and
other indications. Galapagos’ 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.
Galapagos Contacts
Investors:
Media:Elizabeth
Goodwin
Carmen Vroonen VP
IR
Senior Director Communications+1 781 460
1784
+32 473 824
874
Sofie Van Gijsel
Evelyn FoxDirector IR
Director Communications+32 485 19 14
15
+31 6 53 591 999ir@glpg.com
communications@glpg.com
Forward-looking statements
This release may contain forward-looking
statements, including, among other things, statements regarding
Galapagos' strategic ambitions, the mechanism of action and
potential activity of Toledo compounds including GLPG3312 and
GLPG3970; the anticipated timing of clinical trials and
proof-of-concept studies with GLPG3312 and GLPG3970; the
progression and results of such trials, and future regulatory
submissions and Galapagos' interactions with regulatory
authorities. Galapagos cautions the reader that forward-looking
statements are not guarantees of future performance.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos’
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are that Galapagos’ expectations
regarding its GLPG3312 and GLPG3970 development program may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements (including that data from
Galapagos’ ongoing clinical research programs may not support
registration or further development of Toledo compounds including
GLPG3312 and GLPG3970 due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties, and
estimating the commercial potential of Toledo. A further list and
description of these risks, uncertainties and other risks can be
found in Galapagos’ Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos’ most recent annual
report on Form 20-F filed with the SEC and other filings and
reports filed by Galapagos with the SEC. Given these uncertainties,
the reader is advised not to place any undue reliance on such
forward-looking statements. These forward-looking statements speak
only as of the date of publication of this document. Galapagos
expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or
that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements, unless
specifically required by law or regulation.
1 Pharmacokinetics/pharmacodynamics
2 Data on file
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