MetrioPharm AG Phase II Data in Psoriasis Show Dose-Response, Disease Modifying Activity and Outstanding Safety Profile
- Data confirm trend towards clinical efficacy and outstanding safety profile of MP1032
- Responders demonstrate dose dependency and disease modification
- Data support future development of MP1032 in additional chronic inflammatory diseases
Zurich, October 16, 2019. MetrioPharm AG, a clinical stage biopharmaceutical company, reports positive results from its recently completed Phase II dose finding study of MP1032 in psoriasis patients. The data confirm the trend towards clinical efficacy and outstanding safety profile of MP1032, the lead compound from a new class of proprietary immune modulators developed by MetrioPharm AG.
A total of 155 patients were randomized to two doses (150 mg b.i.d. and 300 mg b.i.d.) and a placebo arm in the MP1032-CT04 study. The primary objectives were the efficacy and safety profile of the two doses of oral MP1032. Two co-primary endpoints were a response in PASI 75 at Week 12 and an improvement in PGA at Week 12.
The overall response rate (defined as PASI 50 and 75) more than doubled over placebo with even a 4-fold increase in PASI 75 responders. Because of the limited overall number of patients enrolled in the trial a statistical significance improvement in efficacy could not be established.
An additional finding was that high dose MP1032 showed a statistically significant reduction in all-cause AEs over placebo thereby confirming the expected benign safety profile.
Wolfgang Brysch, CEO of MetrioPharm AG commented on the results: „We are excited about the results of this trial. As a dose-finding study it has clearly demonstrated a dose-response and informed on optimal dosing in future development.
With respect to drug safety, the results clearly exceeded our expectations. There were no serious adverse events in both treatment arms. What's more: In the higher dose group there was a statistically significant decrease in concomitant non-psoriasis-related diseases in signs and symptoms compared to the placebo arm. This implies that MP1032 may actually have a general health promoting effect, well above its indication-specific therapeutic effect. This positions the product for potential chronic administration in age-related conditions."
MP1032 has shown comprehensive preclinical results in a wide range of age-related diseases like arthritis, neurodegenerative diseases, and inflammatory bowel disease. Oxidative stress has been identified as a key driver of inflammation in all these age-related degenerative diseases ("inflamm-aging"). Wolfgang Brysch: "The MP1032-CT04 study was undertaken to test if targeting oxidative stress produces an anti-inflammatory and disease modifying effect. Psoriasis was chosen as the target disease to demonstrate that disease modification is attainable by controlling oxidative stress. Furthermore, the novel auto-regulatory drug mechanism of MP1032 seems to be very safe and to have a general health-promoting effect. MetrioPharm AG will now use this data to determine which clinical path forward will best realize our opportunities."
About MetrioPharm AG
MetrioPharm AG is a pharmaceutical development company developing drugs for chronic inflammatory diseases such as psoriasis, arthritis, and multiple sclerosis. Such chronic diseases pose the greatest individual health risk. The goal of MetrioPharm AG is to make the therapy of chronic inflammatory diseases more effective and more tolerable. We hope to achieve a healthspan expansion for patients: We want to stop the progression of chronic inflammatory diseases as early as possible and significantly prolong the healthy lifespan of millions of people.
MetrioPharm AG was founded in 2007 and is headquartered in Zurich with research facilities in Berlin.
MP1032 is the lead compound of a class of proprietary immune modulators developed by MetrioPharm AG. 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.
For the first Phase II study with MP1032, the indication psoriasis was selected because this immune-induced inflammatory disease is regarded as a so-called »door-opener indication«. Successes in the treatment of psoriasis have already led to first indications of promise for use in other chronic inflammatory diseases, such as arthritis and multiple sclerosis.
This press release contains forward-looking statements that involve risks and uncertainties and are consistent with MetrioPharm AGs 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 AGs 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.
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