Press Release
03.06.2016
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Show your face: Medac fights systemic sclerosis
The TERGISS Phase 3 Trial with the active substance terguride starts in the summer
Wedel / Tornesch (3 June 2016). Medac
Gesellschaft für klinische Spezialpräparate mbH is
about to start an international, multicentre, pivotal,
phase III trial with the serotonin antagonist
terguride for the treatment of systemic sclerosis.
The aim is to study the efficacy and safety of
terguride compared to placebo in patients with
diffuse cutaneous systemic sclerosis (dcSSc).
The TERGISS (TERGuride plus symptomatic therapy In subjects with diffuse cutaneous Systemic
Sclerosis) trial is scheduled to start in August 20161. In this multicentre study, oral administration of the
active substance terguride will be tested in more than 50 trial centres in 10 countries in a randomised,
double-blind, placebo-controlled trial conducted over 52 weeks. The effect of terguride on fibrotic tissue
damage in the skin and other organs will be investigated and the results will be assessed using the
modified Rodnan Skin Score. Systemic sclerosis is a chronic progressive disease, for which only little
long-term clinical data are available and treatment to date has focussed only on managing the symptoms
in the affected organs2,3. Therefore, the long-term effect of terguride will be tested in a subsequent openlabel phase conducted over a further 52 weeks.
Professor Oliver Distler of the University Hospital Zurich and principle investigator in the TERGISS
trial comments, “For patients with diffuse cutaneous systemic sclerosis, there is no licensed medicine
that has been shown to have a genuine effect on disease progression. We hope that the TERGISS trial
will demonstrate that terguride possesses this disease-modulating efficacy. The available data appear to
indicate that terguride could fulfil an unmet medical need.”
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03.06.2016
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The active substance terguride is a serotonin antagonist which works by modulating the 5-HT2A and 5HT2B receptors with high potency. Terguride thus inhibits serotonin-mediated signal transduction which
is thought to play a key role in the abnormal growth of fibrous connective tissue and vascular
remodelling in various organs associated with dcSSc4. This anti-fibrotic effects of terguride were only
discovered recently and have been confirmed in a pilot study with dcSSc patients5.
Medac is convinced of terguride’s novel mode of action and expects to obtain clinical data from the
TERGISS trial that can be used to establish a successful treatment for diffuse cutaneous systemic
sclerosis. Medac brings its many years of expertise from the fields of rheumatological and
dermatological autoimmune diseases to this promising development program on terguride.
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About systemic sclerosis
Systemic sclerosis (SSc) is a rare chronic inflammatory autoimmune disease which may occur in several bodily
organs simultaneously. This multisystem autoimmune disease is a form of collagenosis (diffuse connective tissue
disease) which involves the hardening of skin and subcutaneous tissue and affects many internal organs (e.g. lungs,
gastrointestinal tract, heart and kidneys) and the blood vessels to varying degrees. Excessive collagen production
and accumulation leads to fibrosis of the skin and internal organs and makes a substantial contribution to the high
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morbidity and increased mortality associated with SSc . The famous artist Paul Klee who died in 1940 is
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considered to have been afflicted with this disease . Diffuse cutaneous systemic sclerosis is associated with an
increased risk of mortality.
About terguride
Terguride is an ergoline derivative. The best-known natural representatives of this class of agents are the ergot
alkaloids. Terguride modulates a spectrum of receptors such as serotonin, dopamine and α2-adrenergic receptors
with high affinity. The pharmacodynamic properties and safety profile of terguride are well understood, and the
substance is well tolerated. The active substance was initially developed as a prolactin-lowering agent to treat
hyperprolactinaemic diseases (e.g. ovulatory disorders and galactorrhoea) and prolactin-producing pituitary
tumours. Terguride has already been used successfully in these indications in numerous patients in Japan and the
Czech Republic.
About medac
medac Gesellschaft für klinische Spezialpräparate mbH is a privately held German pharmaceutical company
founded in 1970 and located in the Greater Hamburg area. Medicinal products from medac support doctors and
patients throughout the world in overcoming their acute and persistent diseases in the indication areas of oncology
& haematology, urology and autoimmune disorders. In addition, medac develops and markets special diagnostic
test systems. Since 1999, Medac has had an affiliate office in Scandinavia, servicing the healthcare sector in
Sweden, Denmark and Norway and Iceland.
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Press contact for Denmark, Sweden and Norway:
Henrik Fenger
General Manager, Scandinavia
Mobile: +45 2232 9080
E-mail: [email protected]
Kungsgatan 32
Box 120
432 23 Varberg
Sweden
www.medac.se
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EudraCT number of the TERGISS Study: 2015-002586-39
The clinical trial centres are located in Germany, Switzerland, the Netherlands, Italy, France, Portugal,
Poland, Romania and Hungary and will start the trial successively in the course of the year
Meier, FMP et al., Update on the profile of the EUSTAR cohort: an analysis of the EULAR
Scleroderma Trials and Research group. Ann Rheum Dis 2012;71:1355-1360
Kowal-Bielecka O et al., EULAR recommendations for the treatment of systemic sclerosis: a report
from the EULAR Scleroderma Trials and Research group (EUSTAR). Ann Rheum Dis 2009;68:620- 628
Dees C et al., Platelet-derived serotonin links vascular disease and tissue fibrosis. J Exp Med.
2011;208:961-972
Distler O, Cozzio A., Systemic sclerosis and localized scleroderma - current concepts and novel targets
for therapy. Semin Immunopathol. 2016;38:87-95
Mayes MD et al., Prevalence, Incidence, Survival, and Disease Characteristics of Systemic Sclerosis in
a Large US Population. Arthritis Rheum. 2003;48:2246-2255
Suter H., Case Report on the Illness of Paul Klee (1879-1940). Case Rep Dermatol 2014;6:108-113