First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of PPSGG (PN-1007) in Anti-MAG Neuropathy Patients

In this study, the new drug called PPSGG (PN-1007) will be tested. Preliminary studies conducted in animals suggest PPSGG (PN-1007) might be a good treatment for reducing levels of anti-MAG antibodies in patients with anti-MAG neuropathy.
This is the first research of PPSGG (PN-1007) in people and its main purpose is to test its safety and acceptability in patients. In this study it will be examined how the drug is changed by and removed from the body and checked for signs that the drug may be truly effective against anti-MAG neuropathy. PPSGG (PN-1007) will be tested at several different doses.

开始日期2020-11-17

申办/合作机构

Polyneuron Pharmaceuticals AG初创企业

EUCTR2020-000067-23-FR / Unknown status临床1/2期

First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients

开始日期2020-04-10

申办/合作机构

Polyneuron Pharmaceuticals AG初创企业

100 项与 PN-1007 相关的临床结果

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100 项与 PN-1007 相关的转化医学

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100 项与 PN-1007 相关的专利（医药）

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项与 PN-1007 相关的文献（医药）

2020-09-01·Journal of Neurochemistry2区 · 医学

Selective inhibition of anti‐MAG IgM autoantibody binding to myelin by an antigen‐specific glycopolymer

2区 · 医学

Article

作者: Derfuss, Tobias ; Brodovitch, Alexandre ; Aliu, Butrint ; Théaudin, Marie ; Delmont, Emilien ; Hänggi, Pascal ; Oberholzer, Thomas ; Boucraut, José ; Herrendorff, Ruben ; Demeestere, Delphine ; Steck, Andreas J. ; Seydoux, Emilie ; Tsouni, Pinelopi ; Kuntzer, Thierry ; Attarian, Shahram ; Ernst, Beat

AbstractAnti‐myelin‐associated glycoprotein (MAG) neuropathy is a disabling autoimmune peripheral neuropathy that is caused by circulating monoclonal IgM autoantibodies directed against the human natural killer‐1 (HNK‐1) epitope. This carbohydrate epitope is highly expressed on adhesion molecules such as MAG, a glycoprotein present in myelinated nerves. We previously showed the therapeutic potential of the glycopolymer poly(phenyl disodium 3‐O‐sulfo‐β‐d‐glucopyranuronate)‐(1→3)‐β‐d‐galactopyranoside (PPSGG) in selectively neutralizing anti‐MAG IgM antibodies in an immunological mouse model and ex vivo with sera from anti‐MAG neuropathy patients. PPSGG is composed of a biodegradable backbone that multivalently presents a mimetic of the HNK‐1 epitope. In this study, we further explored the pharmacodynamic properties of the glycopolymer and its ability to inhibit the binding of anti‐MAG IgM to peripheral nerves. The polymer selectively bound anti‐MAG IgM autoantibodies and prevented the binding of patients’ anti‐MAG IgM antibodies to myelin of non‐human primate sciatic nerves. Upon PPSGG treatment, neither activation nor inhibition of human and murine peripheral blood mononuclear cells nor alteration of systemic inflammatory markers was observed in mice or ex vivo in human peripheral blood mononuclear cells. Intravenous injections of PPSGG to mice immunized against the HNK‐1 epitope removed anti‐MAG IgM antibodies within less than 1 hr, indicating a fast and efficient mechanism of action as compared to a B‐cell depletion with anti‐CD20. In conclusion, these observations corroborate the therapeutic potential of PPSGG for an antigen‐specific treatment of anti‐MAG neuropathy.

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Read the Editorial Highlight for this article on page 465.

100 项与 PN-1007 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
周围神经系统疾病	临床2期	-	Polyneuron Pharmaceuticals AG初创企业	-
中枢神经系统疾病	临床1期	瑞士	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
中枢神经系统疾病	临床1期	法国	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
中枢神经系统疾病	临床1期	西班牙	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
中枢神经系统疾病	临床1期	英国	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
中枢神经系统疾病	临床1期	荷兰	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
神经病	临床1期	法国	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
神经病	临床1期	西班牙	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
神经病	临床1期	英国	Polyneuron Pharmaceuticals AG初创企业	2020-11-17
抗髓鞘少突胶质细胞糖蛋白免疫球蛋白Ｇ抗体相关疾病	临床1期	法国	Polyneuron Pharmaceuticals AG初创企业	2020-09-21