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Article ; Online: Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model.

Saadeddin, Anas / Purohit, Vivek / Huh, Yeamin / Wong, Mei / Maulny, Aurelia / Dowty, Martin E / Sagawa, Kazuko

The AAPS journal

2024 Volume 26, Issue 2, Page(s) 27

Language	English
Publishing date	2024-02-21
Publishing country	United States
Document type	Published Erratum
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-024-00895-w
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Article ; Online: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model.

Saadeddin, Anas / Purohit, Vivek / Huh, Yeamin / Wong, Mei / Maulny, Aurelia / Dowty, Martin E / Sagawa, Kazuko

The AAPS journal

2024 Volume 26, Issue 1, Page(s) 17

Abstract: Ritlecitinib, an orally available Janus kinase 3 and tyrosine kinase inhibitor being developed for the treatment of alopecia areata (AA), is highly soluble across the physiological pH range at the therapeutic dose. As such, it is expected to dissolve ... ...

Abstract	Ritlecitinib, an orally available Janus kinase 3 and tyrosine kinase inhibitor being developed for the treatment of alopecia areata (AA), is highly soluble across the physiological pH range at the therapeutic dose. As such, it is expected to dissolve rapidly in any in vitro dissolution conditions. However, in vitro dissolution data showed slower dissolution for 100-mg capsules, used for the clinical bioequivalence (BE) study, compared with proposed commercial 50-mg capsules. Hence, a biowaiver for the lower 50-mg strength using comparable multimedia dissolution based on the f2 similarity factor was not possible. The in vivo relevance of this observed in vitro dissolution profile was evaluated with a physiologically based pharmacokinetic (PBPK) model. This report describes the development, verification, and application of the ritlecitinib PBPK model to translate observed in vitro dissolution data to an in vivo PK profile for ritlecitinib capsule formulations. Virtual BE (VBE) trials were conducted using the Simcyp VBE module, including the model-predicted within-subject variability or intra-subject coefficient of variation (ICV). The results showed the predicted ICV was predicted to be smaller than observed clinical ICV, resulting in a more optimistic BE risk assessment. Additional VBE assessment was conducted by incorporating clinically observed ICV. The VBE trial results including clinically observed ICV demonstrated that proposed commercial 50-mg capsules vs clinical 100-mg capsules were bioequivalent, with > 90% probability of success. This study demonstrates a PBPK model-based biowaiver for a clinical BE study while introducing a novel method to integrate clinically observed ICV into VBE trials with PBPK models. Trial registration: NCT02309827, NCT02684760, NCT04004663, NCT04390776, NCT05040295, NCT05128058.
MeSH term(s)	Humans ; Therapeutic Equivalency ; Alopecia Areata ; Probability ; Protein Kinase Inhibitors ; Risk Assessment
Chemical Substances	Protein Kinase Inhibitors
Language	English
Publishing date	2024-01-24
Publishing country	United States
Document type	Journal Article
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-024-00888-9
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Article ; Online: The complexities of hydrolytic enzymes from the termite digestive system.

Saadeddin, Anas

Critical reviews in biotechnology

2014 Volume 34, Issue 2, Page(s) 115–122

Abstract: The main challenge in second generation bioethanol production is the efficient breakdown of cellulose to sugar monomers (hydrolysis). Due to the recalcitrant character of cellulose, feedstock pretreatment and adapted hydrolysis steps are needed to obtain ...

Abstract	The main challenge in second generation bioethanol production is the efficient breakdown of cellulose to sugar monomers (hydrolysis). Due to the recalcitrant character of cellulose, feedstock pretreatment and adapted hydrolysis steps are needed to obtain fermentable sugar monomers. The conventional industrial production process of second-generation bioethanol from biomass comprises several steps: thermochemical pretreatment, enzymatic hydrolysis and sugar fermentation. This process is undergoing continuous optimization in order to increase the bioethanol yield and reduce the economic cost. Therefore, the discovery of new enzymes with high lignocellulytic activity or new strategies is extremely important. In nature, wood-feeding termites have developed a sophisticated and efficient cellulose degrading system in terms of the rate and extent of cellulose hydrolysis and exploitation. This system, which represents a model for digestive symbiosis has attracted the attention of biofuel researchers. This review describes the termite digestive system, gut symbionts, termite enzyme resources, in vitro studies of isolated enzymes and lignin degradation in termites.
MeSH term(s)	Animals ; Biofuels ; Biomass ; Cellulases ; Digestive System/enzymology ; Digestive System/microbiology ; Digestive System/parasitology ; Hydrolysis ; Isoptera/enzymology ; Isoptera/microbiology ; Isoptera/parasitology ; Isoptera/physiology ; Lignin/metabolism ; Symbiosis
Chemical Substances	Biofuels ; Lignin (9005-53-2) ; Cellulases (EC 3.2.1.-)
Language	English
Publishing date	2014-06
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1042364-3
ISSN	1549-7801 ; 0738-8551
ISSN (online)	1549-7801
ISSN	0738-8551
DOI	10.3109/07388551.2012.727379
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Article ; Online: Recent trends in ionic liquid (IL) tolerant enzymes and microorganisms for biomass conversion.

Portillo, Maria Del Carmen / Saadeddin, Anas

Critical reviews in biotechnology

2015 Volume 35, Issue 3, Page(s) 294–301

Abstract: Second generation biofuel production depends on lignocellulosic (LC) biomass transformation into simple sugars and their subsequent fermentation into alcohols. However, the main obstacle in this process is the efficient breakdown of the recalcitrant ... ...

Abstract	Second generation biofuel production depends on lignocellulosic (LC) biomass transformation into simple sugars and their subsequent fermentation into alcohols. However, the main obstacle in this process is the efficient breakdown of the recalcitrant cellulose to sugar monomers. Hence, efficient feedstock pretreatment and hydrolysis are necessary to produce a cost effective biofuel. Recently, ionic liquids (ILs) have been recognized as a promising solvent able to dissolve different biomass feedstocks, providing higher sugar yields. However, most of the hydrolytic enzymes and microorganisms are inactivated, completely or partially, in the presence of even low concentrations of IL, making necessary the discovery of novel hydrolytic enzymes and fermentative microorganisms that are tolerant to ILs. In this review, the current state and the challenges of using ILs as a pretreatment of LC biomass was evaluated, underlining the advances in the discovery and identification of new IL-tolerant enzymes and microorganisms that could improve the bioprocessing of biomass to fuels and chemicals.
MeSH term(s)	Bacteria/enzymology ; Bacterial Proteins/chemistry ; Bacterial Proteins/drug effects ; Bacterial Proteins/metabolism ; Biofuels ; Biomass ; Biotechnology ; Enzyme Stability ; Ionic Liquids/chemistry ; Ionic Liquids/pharmacology
Chemical Substances	Bacterial Proteins ; Biofuels ; Ionic Liquids
Language	English
Publishing date	2015
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1042364-3
ISSN	1549-7801 ; 0738-8551
ISSN (online)	1549-7801
ISSN	0738-8551
DOI	10.3109/07388551.2013.843069
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Article ; Online: The cellulolytic system of Thermobifida fusca.

Gomez del Pulgar, Eva Maria / Saadeddin, Anas

Critical reviews in microbiology

2014 Volume 40, Issue 3, Page(s) 236–247

Abstract: The process of bioethanol production from biomass comprises pretreatments and enzyme-mediated hydrolysis to convert lignocellulose into fermentable sugars. Because of the recalcitrant character of cellulose, the enzymatic hydrolysis is considered the ... ...

Abstract	The process of bioethanol production from biomass comprises pretreatments and enzyme-mediated hydrolysis to convert lignocellulose into fermentable sugars. Because of the recalcitrant character of cellulose, the enzymatic hydrolysis is considered the major challenge in this process to be economically competitive. These technical difficulties highlight the need for the discovery of new enzymes to optimize and lower the cost of current technologies. Microorganisms have developed efficient systems for cellulose degradation. Among cellulolytic microbes, Thermobifida fusca possesses great physiological and cellulolytic characteristics (thermostability, high activity and tolerance to a broad pH range) making it an interesting organism to be studied from an applied perspective. In this review we describe the main enzymes/proteins produced by T.fusca (cellulases, xylanases, mannanase, manosidase, CBM33 and CelR), the effect of substrate on T. fusca proteome, enzyme improvement approaches, synergism between enzymes/proteins and artificial cellulosomes.
MeSH term(s)	Actinomycetales/drug effects ; Actinomycetales/enzymology ; Actinomycetales/metabolism ; Actinomycetales/radiation effects ; Cellulosomes/drug effects ; Cellulosomes/enzymology ; Cellulosomes/metabolism ; Cellulosomes/radiation effects ; Enzyme Stability ; Enzymes/chemistry ; Enzymes/metabolism ; Ethanol/metabolism ; Hydrogen-Ion Concentration ; Lignin/metabolism ; Temperature
Chemical Substances	Enzymes ; lignocellulose (11132-73-3) ; Ethanol (3K9958V90M) ; Lignin (9005-53-2)
Language	English
Publishing date	2014-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1053620-6
ISSN	1549-7828 ; 1040-841X
ISSN (online)	1549-7828
ISSN	1040-841X
DOI	10.3109/1040841X.2013.776512
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Zs.A 1025: Show issues

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Article ; Online: Population pharmacokinetic analysis of vancomycin in neonates. A new proposal of initial dosage guideline.

Marqués-Miñana, María-Remedios / Saadeddin, Anas / Peris, José-Esteban

British journal of clinical pharmacology

2010 Volume 70, Issue 5, Page(s) 713–720

Abstract: Aim: To determine the population pharmacokinetic parameters of vancomycin in neonatal patients with a wide range of gestational age and birth weight, and subsequently to design an initial dosing schedule for vancomycin in neonates.: Methods: Using ... ...

Abstract	Aim: To determine the population pharmacokinetic parameters of vancomycin in neonatal patients with a wide range of gestational age and birth weight, and subsequently to design an initial dosing schedule for vancomycin in neonates. Methods: Using nonlinear mixed-effects modelling (NONMEM VI), the pharmacokinetics of vancomycin were investigated in 70 neonates with postmenstrual age and body weight ranging 25.1-48.1 weeks and 0.7-3.7kg, respectively. A one-compartment linear disposition model with zero order input and first-order elimination was used to describe the data. Nine demographic characteristics and 21 co-administered drugs were evaluated as covariates of clearance (CL) and distribution volume (V(d) ) of vancomycin. Results: Weight-normalized clearance of vancomycin was influenced by postmenstrual age (PMA) and co-administration of amoxicillin-clavulanic acid. Weight-normalized volume of distribution was influenced by co-administration of spironolactone. CL and V(d) of the typical individual in this study population (PMA = 34.6 weeks, weight = 1.7kg) were estimated to be 0.066lh(-1) kg(-1) (95% CI 0.059, 0.073lh(-1) kg(-1) ) and 0.572lkg(-1) (95% CI 0.505, 0.639lkg(-1) ), respectively. This model was used to predict a priori serum vancomycin concentrations in a validation group (n= 41), which were compared with observed concentrations to determine the predictive performance of the model. The 95% confidence interval of mean prediction error included zero for both peak and trough vancomycin concentrations. Conclusions: Postmenstrual age, co-administration of amoxicillin-clavulanic acid and spironolactone have a significant effect on the weight-normalized CL and V(d) . An initial dosage guideline for vancomycin is proposed for preterm and full-term neonates, whereas the population pharmacokinetic model can be used for dosage individualization of vancomycin.
MeSH term(s)	Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/blood ; Anti-Bacterial Agents/pharmacokinetics ; Birth Weight ; Gestational Age ; Humans ; Infant, Newborn ; Metabolic Clearance Rate ; Models, Biological ; Vancomycin/administration & dosage ; Vancomycin/blood ; Vancomycin/pharmacokinetics
Chemical Substances	Anti-Bacterial Agents ; Vancomycin (6Q205EH1VU)
Language	English
Publishing date	2010-10-29
Publishing country	England
Document type	Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/j.1365-2125.2010.03736.x
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Zs.A 1118: Show issues

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Article ; Online: Living biointerfaces based on non-pathogenic bacteria to direct cell differentiation.

Rodrigo-Navarro, Aleixandre / Rico, Patricia / Saadeddin, Anas / Garcia, Andres J / Salmeron-Sanchez, Manuel

Scientific reports

2014 Volume 4, Page(s) 5849

Abstract: Genetically modified Lactococcus lactis, non-pathogenic bacteria expressing the FNIII(7-10) fibronectin fragment as a protein membrane have been used to create a living biointerface between synthetic materials and mammalian cells. This FNIII(7-10) ... ...

Abstract	Genetically modified Lactococcus lactis, non-pathogenic bacteria expressing the FNIII(7-10) fibronectin fragment as a protein membrane have been used to create a living biointerface between synthetic materials and mammalian cells. This FNIII(7-10) fragment comprises the RGD and PHSRN sequences of fibronectin to bind α5β1 integrins and triggers signalling for cell adhesion, spreading and differentiation. We used L. lactis strain to colonize material surfaces and produce stable biofilms presenting the FNIII(7-10) fragment readily available to cells. Biofilm density is easily tunable and remains stable for several days. Murine C2C12 myoblasts seeded over mature biofilms undergo bipolar alignment and form differentiated myotubes, a process triggered by the FNIII(7-10) fragment. This biointerface based on living bacteria can be further modified to express any desired biochemical signal, establishing a new paradigm in biomaterial surface functionalisation for biomedical applications.
MeSH term(s)	Amino Acid Motifs ; Animals ; Biofilms/growth & development ; Cell Adhesion ; Cell Differentiation ; Cell Line ; Fibronectins/chemistry ; Fibronectins/genetics ; Fibronectins/metabolism ; Integrin alpha5beta1/chemistry ; Integrin alpha5beta1/genetics ; Integrin alpha5beta1/metabolism ; Lactococcus lactis/chemistry ; Lactococcus lactis/genetics ; Lactococcus lactis/growth & development ; Mice ; Molecular Sequence Data ; Muscle Fibers, Skeletal/cytology ; Muscle Fibers, Skeletal/metabolism ; Myoblasts/cytology ; Myoblasts/metabolism ; Protein Binding ; Signal Transduction ; Tissue Scaffolds ; Transgenes
Chemical Substances	Fibronectins ; Integrin alpha5beta1
Language	English
Publishing date	2014-07-28
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/srep05849
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Article ; Online: FLYWCH1, a Novel Suppressor of Nuclear β-Catenin, Regulates Migration and Morphology in Colorectal Cancer.

Muhammad, Belal A / Almozyan, Sheema / Babaei-Jadidi, Roya / Onyido, Emenike K / Saadeddin, Anas / Kashfi, Seyed Hossein / Spencer-Dene, Bradley / Ilyas, Mohammad / Lourdusamy, Anbarasu / Behrens, Axel / Nateri, Abdolrahman S

Molecular cancer research : MCR

2018 Volume 16, Issue 12, Page(s) 1977–1990

Abstract: Wnt/β-catenin signaling plays a critical role during development of both normal and malignant colorectal cancer tissues. Phosphorylation of β-catenin protein alters its trafficking and function. Such conventional allosteric regulation usually involves a ... ...

Abstract	Wnt/β-catenin signaling plays a critical role during development of both normal and malignant colorectal cancer tissues. Phosphorylation of β-catenin protein alters its trafficking and function. Such conventional allosteric regulation usually involves a highly specialized set of molecular interactions, which may specifically turn on a particular cell phenotype. This study identifies a novel transcription modulator with an FLYWCH/Zn-finger DNA-binding domain, called "FLYWCH1." Using a modified yeast-2-hybrid based Ras-Recruitment system, it is demonstrated that FLYWCH1 directly binds to unphosphorylated (nuclear) β-catenin efficiently suppressing the transcriptional activity of Wnt/β-catenin signaling that cannot be rescued by TCF4. FLYWCH1 rearranges the transcriptional activity of β-catenin/TCF4 to selectively block the expression of specific downstream genes associated with colorectal cancer cell migration and morphology, including ZEB1, EPHA4, and E-cadherin. Accordingly, overexpression of FLYWCH1 reduces cell motility and increases cell attachment. The expression of FLYWCH1 negatively correlates with the expression level of ZEB1 and EPHA4 in normal versus primary and metastatic colorectal cancer tissues in patients. Thus, FLYWCH1 antagonizes β-catenin/TCF4 signaling during cell polarity/migration in colorectal cancer. IMPLICATIONS: This study uncovers a new molecular mechanism by which FLYWCH1 with a possible tumor suppressive role represses β-catenin-induced ZEB1 and increases cadherin-mediated cell attachment preventing colorectal cancer metastasis.
MeSH term(s)	Antigens, CD/metabolism ; Cadherins/metabolism ; Cell Line, Tumor ; Cell Movement ; Colorectal Neoplasms/metabolism ; DNA-Binding Proteins/chemistry ; DNA-Binding Proteins/metabolism ; Down-Regulation ; Gene Expression Regulation, Neoplastic ; HCT116 Cells ; Humans ; Tissue Array Analysis ; Wnt Signaling Pathway ; Zinc Finger E-box-Binding Homeobox 1/metabolism ; Zinc Fingers ; beta Catenin/metabolism
Chemical Substances	Antigens, CD ; CDH1 protein, human ; CTNNB1 protein, human ; Cadherins ; DNA-Binding Proteins ; FLYWCH1 protein, human ; ZEB1 protein, human ; Zinc Finger E-box-Binding Homeobox 1 ; beta Catenin
Language	English
Publishing date	2018-08-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2098788-2
ISSN	1557-3125 ; 1541-7786
ISSN (online)	1557-3125
ISSN	1541-7786
DOI	10.1158/1541-7786.MCR-18-0262
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Zs.A 5744: Show issues

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Article ; Online: Development of Chemical Entities Endowed with Potent Fast-Killing Properties against

Matralis, Alexios N / Malik, Adnan / Penzo, Maria / Moreno, Inmaculada / Almela, Maria J / Camino, Isabel / Crespo, Benigno / Saadeddin, Anas / Ghidelli-Disse, Sonja / Rueda, Lourdes / Calderon, Felix / Osborne, Simon A / Drewes, Gerard / Böesche, Markus / Fernández-Álvaro, Elena / Martin Hernando, Jose Ignacio / Baker, David A

Journal of medicinal chemistry

2019 Volume 62, Issue 20, Page(s) 9217–9235

Abstract: One of the attractive properties of artemisinins is their extremely fast-killing capability, quickly relieving malaria symptoms. Nevertheless, the unique benefits of these medicines are now compromised by the prolonged parasite clearance times and the ... ...

Abstract	One of the attractive properties of artemisinins is their extremely fast-killing capability, quickly relieving malaria symptoms. Nevertheless, the unique benefits of these medicines are now compromised by the prolonged parasite clearance times and the increasing frequency of treatment failures, attributed to the increased tolerance of
MeSH term(s)	Antimalarials/chemistry ; Antimalarials/metabolism ; Antimalarials/pharmacology ; Artemisinins/chemistry ; Artemisinins/metabolism ; Artemisinins/pharmacology ; Cyclic GMP-Dependent Protein Kinases/antagonists & inhibitors ; Cyclic GMP-Dependent Protein Kinases/genetics ; Cyclic GMP-Dependent Protein Kinases/metabolism ; ERG1 Potassium Channel/antagonists & inhibitors ; ERG1 Potassium Channel/metabolism ; Humans ; Inhibitory Concentration 50 ; Mutagenesis, Site-Directed ; Plasmodium falciparum/drug effects ; Plasmodium falciparum/growth & development ; Protozoan Proteins/antagonists & inhibitors ; Protozoan Proteins/genetics ; Protozoan Proteins/metabolism ; Solubility ; Structure-Activity Relationship ; Thiazoles/chemistry
Chemical Substances	Antimalarials ; Artemisinins ; ERG1 Potassium Channel ; KCNH2 protein, human ; Protozoan Proteins ; Thiazoles ; artemisinin (9RMU91N5K2) ; Cyclic GMP-Dependent Protein Kinases (EC 2.7.11.12)
Language	English
Publishing date	2019-10-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	218133-2
ISSN	1520-4804 ; 0022-2623
ISSN (online)	1520-4804
ISSN	0022-2623
DOI	10.1021/acs.jmedchem.9b01099
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Article: The cellulolytic system of Thermobifida fusca

Gomez del Pulgar, Eva Maria / Saadeddin, Anas

Critical reviews in microbiology. 2014 Aug. 1, v. 40, no. 3

2014

Abstract	The process of bioethanol production from biomass comprises pretreatments and enzyme-mediated hydrolysis to convert lignocellulose into fermentable sugars. Because of the recalcitrant character of cellulose, the enzymatic hydrolysis is considered the major challenge in this process to be economically competitive. These technical difficulties highlight the need for the discovery of new enzymes to optimize and lower the cost of current technologies. Microorganisms have developed efficient systems for cellulose degradation. Among cellulolytic microbes, Thermobifida fusca possesses great physiological and cellulolytic characteristics (thermostability, high activity and tolerance to a broad pH range) making it an interesting organism to be studied from an applied perspective. In this review we describe the main enzymes/proteins produced by T.fusca (cellulases, xylanases, mannanase, manosidase, CBM33 and CelR), the effect of substrate on T. fusca proteome, enzyme improvement approaches, synergism between enzymes/proteins and artificial cellulosomes.
Keywords	Thermobifida fusca ; beta-mannosidase ; biomass ; cellulases ; cellulose ; cellulosome ; enzymatic hydrolysis ; ethanol production ; hydrolysis ; lignocellulose ; microorganisms ; pH ; proteins ; proteome ; sugars ; synergism ; thermal stability ; xylanases
Language	English
Dates of publication	2014-0801
Size	p. 236-247.
Publishing place	Taylor & Francis
Document type	Article
ZDB-ID	1053620-6
ISSN	1549-7828 ; 1040-841X
ISSN (online)	1549-7828
ISSN	1040-841X
DOI	10.3109/1040841X.2013.776512
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