Pharmacokinetic and Preclinical Safety Studies of Endolysin-Based Therapeutic for Intravenous Administration
•A murine pharmacokinetic study for endolysin LysECD7-SMAP lyophilizate was performed.•Therapeutic concentrations were observed in serum for 60 min after bolus i.v. administration.•Endolysin distributes in blood, degrades in blood and liver, and eliminates via kidney.•LysECD7-SMAP is safe in toxicol...
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Published in | International journal of antimicrobial agents Vol. 64; no. 5; p. 107328 |
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Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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01.11.2024
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Abstract | •A murine pharmacokinetic study for endolysin LysECD7-SMAP lyophilizate was performed.•Therapeutic concentrations were observed in serum for 60 min after bolus i.v. administration.•Endolysin distributes in blood, degrades in blood and liver, and eliminates via kidney.•LysECD7-SMAP is safe in toxicology, immunotoxicity, and allergenicity studies in rodents.
Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed a novel drug for intravenous administration (lyophilizate) containing modified endolysin LysECD7-SMAP that showed notable antibacterial effect in different animal models of systemic infections. Here we present data on pharmacokinetics of endolysin in mice after single and multiple injections. Time-concentration curves were obtained, and pharmacokinetic parameters for preparation (C0, kel t1/2, AUC0–∞, MRT, ClT, Vss) were calculated. It was shown that although endolysin is rather short-lived in blood serum (t1/2 = 12.5 min), the therapeutic concentrations of LysECD7-SMAP (in degraded and non-degraded form) were detected for 60 minutes after injection that is sufficient for antibacterial effect. Based on the obtained data, it was proposed that endolysin distributes presumably in murine blood, degrades in blood and liver, and is eliminated via glomerular filtration. Safety profile of the preparation relating to general toxicity, immunotoxicity and allergenicity was assessed in rodents. It was demonstrated that LysECD7-SMAP in potential therapeutic (12.5 mg/kg), 10-fold (125 mg/kg) and 40-fold (500 mg/kg) doses showed no signs of intoxication and significant abnormalities after single and repeated i.v. administrations, preparation was non-immunogenic and induced minor and reversible allergic reaction in animals.
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AbstractList | Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed novel drug for intravenous administration (lyophilizate) containing modified endolysin LysECD7-SMAP that showed notable antibacterial effect in different animal models of systemic infections. Here we present data on pharmacokinetics of endolysin in mice after single and multiple injections. Time-concentration curves were obtained, pharmacokinetic parameters for preparation (C
, k
t
, AUC
, MRT, Cl
, V
) were calculated. It was shown that although endolysin is rather short-living in blood serum (t
= 12.5 min) the therapeutic concentrations of LysECD7-SMAP (in degraded and non-degraded form) were detected for 60 min after injection that is sufficient for antibacterial effect. Based on the obtained data, it was proposed that endolysin distributes presumably in murine blood, degrades in blood and liver, and is eliminated via glomerular filtration. Safety profile of the preparation relating to general toxicity, immunotoxicity and allergenicity was assessed in rodents. It was demonstrated that LysECD7-SMAP in potential therapeutic (12.5 mg/kg), 10-fold (125 mg/kg) and 40-fold (500 mg/kg) doses showed no signs of intoxication and significant abnormalities after single and repeated i.v. administrations, preparation was non-immunogenic and induced minor and reversible allergic reaction in animal. •A murine pharmacokinetic study for endolysin LysECD7-SMAP lyophilizate was performed.•Therapeutic concentrations were observed in serum for 60 min after bolus i.v. administration.•Endolysin distributes in blood, degrades in blood and liver, and eliminates via kidney.•LysECD7-SMAP is safe in toxicology, immunotoxicity, and allergenicity studies in rodents. Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed a novel drug for intravenous administration (lyophilizate) containing modified endolysin LysECD7-SMAP that showed notable antibacterial effect in different animal models of systemic infections. Here we present data on pharmacokinetics of endolysin in mice after single and multiple injections. Time-concentration curves were obtained, and pharmacokinetic parameters for preparation (C0, kel t1/2, AUC0–∞, MRT, ClT, Vss) were calculated. It was shown that although endolysin is rather short-lived in blood serum (t1/2 = 12.5 min), the therapeutic concentrations of LysECD7-SMAP (in degraded and non-degraded form) were detected for 60 minutes after injection that is sufficient for antibacterial effect. Based on the obtained data, it was proposed that endolysin distributes presumably in murine blood, degrades in blood and liver, and is eliminated via glomerular filtration. Safety profile of the preparation relating to general toxicity, immunotoxicity and allergenicity was assessed in rodents. It was demonstrated that LysECD7-SMAP in potential therapeutic (12.5 mg/kg), 10-fold (125 mg/kg) and 40-fold (500 mg/kg) doses showed no signs of intoxication and significant abnormalities after single and repeated i.v. administrations, preparation was non-immunogenic and induced minor and reversible allergic reaction in animals. [Display omitted] Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed a novel drug for intravenous administration (lyophilizate) containing modified endolysin LysECD7-SMAP that showed notable antibacterial effect in different animal models of systemic infections. Here we present data on pharmacokinetics of endolysin in mice after single and multiple injections. Time-concentration curves were obtained, and pharmacokinetic parameters for preparation (C0, kel t1/2, AUC0-∞, MRT, ClT, Vss) were calculated. It was shown that although endolysin is rather short-lived in blood serum (t1/2 = 12.5 min), the therapeutic concentrations of LysECD7-SMAP (in degraded and non-degraded form) were detected for 60 minutes after injection that is sufficient for antibacterial effect. Based on the obtained data, it was proposed that endolysin distributes presumably in murine blood, degrades in blood and liver, and is eliminated via glomerular filtration. Safety profile of the preparation relating to general toxicity, immunotoxicity and allergenicity was assessed in rodents. It was demonstrated that LysECD7-SMAP in potential therapeutic (12.5 mg/kg), 10-fold (125 mg/kg) and 40-fold (500 mg/kg) doses showed no signs of intoxication and significant abnormalities after single and repeated i.v. administrations, preparation was non-immunogenic and induced minor and reversible allergic reaction in animals.Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed a novel drug for intravenous administration (lyophilizate) containing modified endolysin LysECD7-SMAP that showed notable antibacterial effect in different animal models of systemic infections. Here we present data on pharmacokinetics of endolysin in mice after single and multiple injections. Time-concentration curves were obtained, and pharmacokinetic parameters for preparation (C0, kel t1/2, AUC0-∞, MRT, ClT, Vss) were calculated. It was shown that although endolysin is rather short-lived in blood serum (t1/2 = 12.5 min), the therapeutic concentrations of LysECD7-SMAP (in degraded and non-degraded form) were detected for 60 minutes after injection that is sufficient for antibacterial effect. Based on the obtained data, it was proposed that endolysin distributes presumably in murine blood, degrades in blood and liver, and is eliminated via glomerular filtration. Safety profile of the preparation relating to general toxicity, immunotoxicity and allergenicity was assessed in rodents. It was demonstrated that LysECD7-SMAP in potential therapeutic (12.5 mg/kg), 10-fold (125 mg/kg) and 40-fold (500 mg/kg) doses showed no signs of intoxication and significant abnormalities after single and repeated i.v. administrations, preparation was non-immunogenic and induced minor and reversible allergic reaction in animals. |
ArticleNumber | 107328 |
Author | Gushchin, Vladimir A. Zackharova, Anastasia A. Yudin, Sergey M. Makarov, Valentine V. Vasina, Daria V. Remizov, Timofey A. Savinov, Vasiliy A. Antonova, Nataliia P. Kapustin, Andrey V. Laishevtsev, Aleksei I. Grigoriev, Igor V. Vorobev, Aleksei M. Aleshkin, Andrei V. |
Author_xml | – sequence: 1 givenname: Nataliia P. orcidid: 0000-0001-7025-8056 surname: Antonova fullname: Antonova, Nataliia P. organization: Laboratory of Pathogen Population Variability Mechanisms, N.F. Gamaleya National Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Moscow, Russia – sequence: 2 givenname: Daria V. surname: Vasina fullname: Vasina, Daria V. organization: Laboratory of Pathogen Population Variability Mechanisms, N.F. Gamaleya National Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Moscow, Russia – sequence: 3 givenname: Igor V. orcidid: 0000-0001-6946-2156 surname: Grigoriev fullname: Grigoriev, Igor V. organization: Translational Biomedicine Laboratory, N.F. Gamaleya National Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Moscow, Russia – sequence: 4 givenname: Aleksei I. surname: Laishevtsev fullname: Laishevtsev, Aleksei I. organization: Federal State Budget Scientific Institution “Federal Scientific Centre VIEV” (FSC VIEV), Moscow, Russia – sequence: 5 givenname: Andrey V. surname: Kapustin fullname: Kapustin, Andrey V. organization: Federal State Budget Scientific Institution “Federal Scientific Centre VIEV” (FSC VIEV), Moscow, Russia – sequence: 6 givenname: Vasiliy A. orcidid: 0000-0003-1891-0005 surname: Savinov fullname: Savinov, Vasiliy A. organization: Federal State Budget Scientific Institution “Federal Scientific Centre VIEV” (FSC VIEV), Moscow, Russia – sequence: 7 givenname: Aleksei M. orcidid: 0000-0003-4724-2464 surname: Vorobev fullname: Vorobev, Aleksei M. organization: Laboratory of Clinical Microbiology and Biotechnology of Bacteriophages, G.N. Gabrichevsky Moscow Research Institute for Epidemiology and Microbiology, Moscow, Russia – sequence: 8 givenname: Andrei V. surname: Aleshkin fullname: Aleshkin, Andrei V. organization: Laboratory of Clinical Microbiology and Biotechnology of Bacteriophages, G.N. Gabrichevsky Moscow Research Institute for Epidemiology and Microbiology, Moscow, Russia – sequence: 9 givenname: Anastasia A. surname: Zackharova fullname: Zackharova, Anastasia A. organization: Translational Biomedicine Laboratory, N.F. Gamaleya National Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Moscow, Russia – sequence: 10 givenname: Timofey A. surname: Remizov fullname: Remizov, Timofey A. organization: Translational Biomedicine Laboratory, N.F. Gamaleya National Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Moscow, Russia – sequence: 11 givenname: Valentine V. surname: Makarov fullname: Makarov, Valentine V. organization: Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency, Moscow, Russia – sequence: 12 givenname: Sergey M. surname: Yudin fullname: Yudin, Sergey M. organization: Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency, Moscow, Russia – sequence: 13 givenname: Vladimir A. surname: Gushchin fullname: Gushchin, Vladimir A. email: wowaniada@yandex.ru organization: Laboratory of Pathogen Population Variability Mechanisms, N.F. Gamaleya National Research Centre for Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Moscow, Russia |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39244166$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1007/978-1-62703-050-2_16 10.1007/s11095-017-2219-y 10.1134/S0003683822100027 10.1111/1440-1681.12613 10.3390/antibiotics11070966 10.1016/j.copbio.2020.09.012 10.1080/1040841X.2020.1809346 10.1152/ajprenal.00377.2019 10.4049/jimmunol.85.5.469 10.3390/antibiotics10121497 10.1128/AAC.02232-13 10.3389/fmicb.2021.748718 10.1093/nar/gkaa379 10.1080/19420862.2015.1115937 10.3390/antibiotics10020124 10.1007/978-1-4939-8549-4_7 10.1186/s12929-024-01065-y 10.3390/v10110638 10.2174/138920009789895499 10.3389/fmicb.2022.841905 10.1016/S0149-2918(02)80075-3 10.1155/2017/2680160 10.3390/v13040680 10.1038/s41579-019-0288-0 10.1128/AAC.02629-16 10.3390/biom10030440 |
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Keywords | Endolysin Gram-negative bacteria Safety Intravenous injection Pharmacokinetics Rodents pharmacokinetics gram-negative bacteria endolysin safety intravenous injection rodents |
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Snippet | •A murine pharmacokinetic study for endolysin LysECD7-SMAP lyophilizate was performed.•Therapeutic concentrations were observed in serum for 60 min after bolus... Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed novel drug for... Pharmacokinetics and safety studies of innovative drugs is an essential part of drug development process. Previously we have developed a novel drug for... |
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SubjectTerms | Endolysin Gram-negative bacteria Intravenous injection Pharmacokinetics Rodents Safety |
Title | Pharmacokinetic and Preclinical Safety Studies of Endolysin-Based Therapeutic for Intravenous Administration |
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