Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins

All the botulinum type A neurotoxins available for clinical use are of the A1 subtype. We developed a subtype A2 low-molecular-weight (150 kD (kilo Dalton)) neurotoxin (A2NTX) with less spread and faster entry into the motor nerve terminal than A1 in vitro and in vivo. Preliminary clinical studies s...

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Autores principales:	Toshiaki Takeuchi, Tsuyoshi Okuno, Ai Miyashiro, Tomoko Kohda, Ryosuke Miyamoto, Yuishin Izumi, Shunji Kozaki, Ryuji Kaji
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	botulinum toxin subtype A2 clinical tolerability safety patients Medicine R
Acceso en línea:	https://doaj.org/article/9a9ff29f6a3843ac893cb75e843cbfad
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spelling	oai:doaj.org-article:9a9ff29f6a3843ac893cb75e843cbfad2021-11-25T19:09:11ZClinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins10.3390/toxins131108242072-6651https://doaj.org/article/9a9ff29f6a3843ac893cb75e843cbfad2021-11-01T00:00:00Zhttps://www.mdpi.com/2072-6651/13/11/824https://doaj.org/toc/2072-6651All the botulinum type A neurotoxins available for clinical use are of the A1 subtype. We developed a subtype A2 low-molecular-weight (150 kD (kilo Dalton)) neurotoxin (A2NTX) with less spread and faster entry into the motor nerve terminal than A1 in vitro and in vivo. Preliminary clinical studies showed that its efficacy is superior to A1 toxins. We conducted an open study exploring its safety and tolerability profile in comparison with A1LL (LL type A1 toxin, or onabotulinumtoxinA) and a low-molecular-weight (150 kD) A1 neurotoxin (A1NTX). Those who had been using A1LL (<i>n</i> = 90; 50–360 mouse LD50 units) or A1NTX (<i>n</i> = 30; 50–580 units) were switched to A2NTX (<i>n</i> = 120; 25–600 units) from 2010 to 2018 (number of sessions ~27, cumulative doses ~11,640 units per patient). The adverse events for A2NTX included weakness (<i>n</i> = 1, ascribed to alcoholic polyneuropathy), dysphagia (1), local weakness (4), and spread to other muscles (1), whereas those for A1LL or A1NTX comprised weakness (<i>n</i> = 2, A1NTX), dysphagia (8), ptosis (6), local weakness (7), and spread to other muscles (15). After injections, 89 out of 120 patients preferred A2NTX to A1 for the successive sessions. The present study demonstrated that A2NTX had clinical safety up to the dose of 500 units and was well tolerated compared to A1 toxins.Toshiaki TakeuchiTsuyoshi OkunoAi MiyashiroTomoko KohdaRyosuke MiyamotoYuishin IzumiShunji KozakiRyuji KajiMDPI AGarticlebotulinum toxinsubtype A2clinical tolerabilitysafetypatientsMedicineRENToxins, Vol 13, Iss 824, p 824 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	botulinum toxin subtype A2 clinical tolerability safety patients Medicine R
spellingShingle	botulinum toxin subtype A2 clinical tolerability safety patients Medicine R Toshiaki Takeuchi Tsuyoshi Okuno Ai Miyashiro Tomoko Kohda Ryosuke Miyamoto Yuishin Izumi Shunji Kozaki Ryuji Kaji Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
description	All the botulinum type A neurotoxins available for clinical use are of the A1 subtype. We developed a subtype A2 low-molecular-weight (150 kD (kilo Dalton)) neurotoxin (A2NTX) with less spread and faster entry into the motor nerve terminal than A1 in vitro and in vivo. Preliminary clinical studies showed that its efficacy is superior to A1 toxins. We conducted an open study exploring its safety and tolerability profile in comparison with A1LL (LL type A1 toxin, or onabotulinumtoxinA) and a low-molecular-weight (150 kD) A1 neurotoxin (A1NTX). Those who had been using A1LL (<i>n</i> = 90; 50–360 mouse LD50 units) or A1NTX (<i>n</i> = 30; 50–580 units) were switched to A2NTX (<i>n</i> = 120; 25–600 units) from 2010 to 2018 (number of sessions ~27, cumulative doses ~11,640 units per patient). The adverse events for A2NTX included weakness (<i>n</i> = 1, ascribed to alcoholic polyneuropathy), dysphagia (1), local weakness (4), and spread to other muscles (1), whereas those for A1LL or A1NTX comprised weakness (<i>n</i> = 2, A1NTX), dysphagia (8), ptosis (6), local weakness (7), and spread to other muscles (15). After injections, 89 out of 120 patients preferred A2NTX to A1 for the successive sessions. The present study demonstrated that A2NTX had clinical safety up to the dose of 500 units and was well tolerated compared to A1 toxins.
format	article
author	Toshiaki Takeuchi Tsuyoshi Okuno Ai Miyashiro Tomoko Kohda Ryosuke Miyamoto Yuishin Izumi Shunji Kozaki Ryuji Kaji
author_facet	Toshiaki Takeuchi Tsuyoshi Okuno Ai Miyashiro Tomoko Kohda Ryosuke Miyamoto Yuishin Izumi Shunji Kozaki Ryuji Kaji
author_sort	Toshiaki Takeuchi
title	Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
title_short	Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
title_full	Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
title_fullStr	Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
title_full_unstemmed	Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins
title_sort	clinical safety and tolerability of a2ntx, a novel low-molecular-weight neurotoxin derived from botulinum neurotoxin subtype a2, in comparison with subtype a1 toxins
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/9a9ff29f6a3843ac893cb75e843cbfad
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Clinical Safety and Tolerability of A2NTX, a Novel Low-Molecular-Weight Neurotoxin Derived from Botulinum Neurotoxin Subtype A2, in Comparison with Subtype A1 Toxins

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