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.

Start Date17 Nov 2020

Sponsor / Collaborator

Polyneuron Pharmaceuticals AGStartup

EUCTR2020-000067-23-FR / Unknown statusPhase 1/2

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

Start Date10 Apr 2020

Sponsor / Collaborator

Polyneuron Pharmaceuticals AGStartup

100 Clinical Results associated with PN-1007

100 Translational Medicine associated with PN-1007

100 Patents (Medical) associated with PN-1007

Literatures (Medical) associated with PN-1007

01 Sep 2020·Journal of NeurochemistryQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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 Deals associated with PN-1007

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Nervous System Diseases	Phase 2	-	Polyneuron Pharmaceuticals AGStartup	-
Central Nervous System Diseases	Phase 1	CH	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Central Nervous System Diseases	Phase 1	FR	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Central Nervous System Diseases	Phase 1	ES	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Central Nervous System Diseases	Phase 1	GB	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Central Nervous System Diseases	Phase 1	NL	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Neuropathy	Phase 1	FR	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Neuropathy	Phase 1	ES	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Neuropathy	Phase 1	GB	Polyneuron Pharmaceuticals AGStartup	17 Nov 2020
Anti-myelin-associated glycoprotein associated polyneuropathy	Phase 1	FR	Polyneuron Pharmaceuticals AGStartup	21 Sep 2020

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