EQS-News: MetrioPharm Announces Positive Top-Line Results from a Phase IIa Study in Moderate-to-Severe Psoriasis with its Oral Lead Compound MP1032
EQS Group-News: MetrioPharm AG / Key word(s): Study results
MetrioPharm Announces Positive Top-Line Results from a Phase IIa Study in
Moderate-to-Severe Psoriasis with its Oral Lead Compound MP1032
14.03.2017 / 10:20
--------------------------------------------------------------------------------
Based on these positive results, MetrioPharm plans to move its MP1032 program
forward into a phase IIb study in moderate-to-severe psoriasis.
Zurich, March 14, 2017.MetrioPharm AG, a biotech company developing small
molecule immune modulators for autoimmune and other inflammatory diseases, today
announces positive top-line results from its phase IIa trial with its
proprietary drug compound MP1032 in patients with moderate-to-severe plaque
psoriasis.
The phase IIa trial conducted at four clinical study sites in Germany was a
randomized (1:1), double-blind, placebo-controlled, study with MP1032 given
orally twice daily. Forty-four patients received six-weeks of treatment with
placebo or MP1032 and were monitored for an additional four-week period.
The primary objectives of the study were to evaluate the safety and
pharmacokinetics (PK) of twice daily 100 mg MP1032 in patients with
moderate-to-severe plaque psoriasis. Enrolled patients had an average age of 40
years (21-65) and a median baseline PASI score of 13.6 (ranging from 10.1 to
40.8).
With regard to safety, the most frequently reported adverse events were common
cold, headache, and itching. All events were mild to moderate and occurred in
both the placebo and MP1032 group. There were no effects on lymphocytes or other
blood-count parameters and no treatment-related gastro-intestinal adverse
effects were reported. No serious or severe adverse events were reported in
patients treated with MP1032. No patient treated with MP1032 discontinued the
trial because of adverse events or tolerability issues.
Exploratory analyses regarding the potential effect of the drug on PASI scores
suggest that patients with MP1032 exposure levels above 120 ng*hr/ml (n=16) have
a median reduction from baseline in PASI score of 25 % as compared to 12 % in
the placebo group at the end of treatment (week 6). Upon discontinuation of
treatment, during the four-week follow up period, median PASI scores in the
treatment group trended back upward while the placebo group remained relatively
unchanged, suggestive of a therapeutic effect of MP1032.
"This phase IIa study suggests a clinically meaningful activity of MP1032 for
the treatment of moderate-to-severe plaque psoriasis. From a clinical point of
view, an oral drug with a better tolerability profile than currently available
drugs, is desirable. I am looking forward to seeing how MP1032 performs in
upcoming clinical trials," said Prof. Wolfgang Vanscheidt, one of the study's
Principal Investigators.
Dr. Wolfgang Brysch, CEO of MetrioPharm said "The positive results from this
trial represent an important milestone in our development program for MP1032. We
are very pleased that MP1032 was well tolerated and that there is a meaningful
trend in response after only six weeks of treatment. We believe that MP1032
could become an effective, and well-tolerated oral treatment option for patients
suffering from moderate-to-severe forms of psoriasis".
Based on the wide pre-clinical safety margin of the drug, the PK data in
psoriasis patients, and the trend in drug effect observed in this trial,
MetrioPharm is planning a three-month phase IIb study in patients with
moderate-to-severe plaque psoriasis with higher doses of MP1032.
About Psoriasis
Psoriasis is a chronic, relapsing, inflammatory, autoimmune skin disorder, which
often manifests as plaque psoriasis. Plaque psoriasis, also known as psoriasis
vulgaris, makes up about 90 % of cases. It typically presents with red patches
with white scales on top. Most commonly affected areas of the body are the back
of the forearms, shins, around the navel, and the scalp.
About MP1032
MP1032 is the lead compound of a class of proprietary immune modulators
developed by MetrioPharm. MP1032 is believed to modulate the H2O2-mediated
activation state of macrophages and downregulate the M1 state. In contrast to
other immune-modulating and disease-modifying drugs, MP1032 does not impact
T-cells and preferentially affects macrophages at the sites of inflammation.
MP1032 has shown anti-inflammatory activity in animal models of disease and a
favorable toxicology profile in pre-clinical studies.
About MetrioPharm
MetrioPharm AG is a biotech company developing oral drug compounds for the
treatment of autoimmune and other inflammatory diseases. MetrioPharm's MP1000
pipeline consists of small molecule immune modulators for unmet medical needs in
Immune-Mediated Inflammatory Diseases (IMIDs).
MetrioPharm AG was founded in 2007 and is headquartered in Zurich with research
facilities in Berlin.
Contact:
Eva Brysch
Manager Investor Relations & Corporate Communications
....................
MetrioPharm AG
Bleicherweg 45
CH-8002 Zürich
MetrioPharm Deutschland GmbH
Am Borsigturm 100
D-13507 Berlin
T +49 (0) 30 33 84 395 40
F +49 (0) 30 33 84 395 99
E invest@metriopharm.com
W www.metriopharm.com
--------------------------------------------------------------------------------
End of Corporate News
--------------------------------------------------------------------------------
Language: English
Company: MetrioPharm AG
Bleicherweg 45
8002 Zurich
Switzerland
Phone: +41 (44) 515 21 97
Fax: +41 (44) 201 74 75
E-mail: info@metriopharm.com
Internet: www.metriopharm.com
ISIN: CH0107076744
Valor: A0YD9Q
End of News EQS Group News Service
--------------------------------------------------------------------------------
553769 14.03.2017