MetrioPharm announces first patient dosed in a clinical phase II trial for MP1032 for the treatment of moderate-to-severe chronic plaque psoriasis
Zurich, March 07, 2018. MetrioPharm AG announces the first dosing of the first patient in its phase II clinical trial MP1032-CT04 on March 06, 2018. MP1032 is an orally available drug and can inhibit inflammation by reducing the concentration of cytokines involved in the inflammatory process of diseases such as chronic plaque psoriasis. So far, MP1032 has demonstrated a better safety profile than currently available systemic drugs. Additionally, first signals of efficacy of MP1032 in patients with moderate-to-severe plaque psoriasis were already obtained in a Phase IIa study completed in March 2017. Due to its good tolerability and the efficacy shown so far, MP1032 has the potential to improve the care of psoriasis patients at an early stage of disease progression. There are currently more than 13 million patients suffering from psoriasis in the US and EU. More than six million of these patients are not treated, primarily because they are dissatisfied with the current treatment options.
The Phase II study is being conducted in Germany and Poland as a multi-center, randomized, double-blind, placebo-controlled, twice-daily oral trial over 12 weeks. Psoriasis patients aged 18 to 70 years receive either MP1032 (150 mg or 300 mg) or placebo. The primary objective of this study is to evaluate the clinical efficacy and safety of MP1032 at different doses.
"I am very proud of the internal and external study teams who were able to start the trial early on shortly after the approvals, so that we were able to randomize the first patient yesterday. We hope to confirm the excellent safety profile of MP1032 and intend to further strengthen the first signs of efficacy in patients shown in Phase IIa and to consolidate them through the longer treatment period and higher dosages," said Dr. Petra Schulz, MetrioPharm AG project manager for the MP1032-CT04 clinical trial.
An enrolment of up to 150 male and female patients with chronic plaque psoriasis (PASI 10-20) is expected in this Phase II clinical trial. The participants are divided into three groups of 50 people each. Around 14 study sites in Germany and Poland will participate in this study.
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.
MP1032 is the lead compound of a class of proprietary immune modulators developed by MetrioPharm. MP1032 is believed to modulate the oxidative stress-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.
MetrioPharm AG is a pharmaceutical biotech company developing 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.
This press release contains forward-looking statements that involve risks and uncertainties and are consistent with MetrioPharm's assessment as of the date of this release. Such forward-looking statements are neither promises nor guarantees, but are subject to numerous risks and uncertainties, many of which are beyond MetrioPharm's control, that could cause actual results to differ materially from those contemplated in these forward-looking statements. MetrioPharm does not assume any obligation to update forward-looking statements with respect to changed expectations or new events, conditions or circumstances on which these statements are based. A liability or guarantee and, if applicable, claims for topicality, correctness and completeness of these data and information are excluded and cannot be derived either explicitly or impliedly.