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Article ; Online: Autopsy Analyses in Neurological Drug Development-Opening the Black Box.

Bishop, Kathie M

2019 Volume 76, Issue 9, Page(s) 1003–1004

Language	English
Publishing date	2019-08-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2702023-X
ISSN	2168-6157 ; 2168-6149
ISSN (online)	2168-6157
ISSN	2168-6149
DOI	10.1001/jamaneurol.2019.2265
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Article ; Online: Exposure-Response Efficacy Modeling to Support Trofinetide Dosing in Individuals with Rett Syndrome.

Darwish, Mona / Passarell, Julie / Youakim, James M / Bradley, Heather / Bishop, Kathie M

Advances in therapy

2024 Volume 41, Issue 4, Page(s) 1462–1480

Abstract: Introduction: Trofinetide was recently approved for the treatment of Rett syndrome (RTT) on the basis of the efficacy and safety findings of the phase 3 LAVENDER study, which used a body weight-based dosing regimen. Exposure-response (E-R) efficacy ... ...

Abstract	Introduction: Trofinetide was recently approved for the treatment of Rett syndrome (RTT) on the basis of the efficacy and safety findings of the phase 3 LAVENDER study, which used a body weight-based dosing regimen. Exposure-response (E-R) efficacy modeling was used to characterize relationships between trofinetide exposure measures (maximum drug concentration and area under the concentration-time curve for the dosing interval of 0-12 h [AUC Methods: Efficacy endpoints were modeled using trofinetide exposure measures predicted from the population pharmacokinetic model and Bayesian estimates. The analysis population for each E-R model comprised individuals receiving placebo or trofinetide who had available trofinetide exposure measures. Efficacy endpoints were scores from the Rett Syndrome Behaviour Questionnaire (RSBQ), the Clinical Global Impression-Improvement, the Communication and Symbolic Behavior Scales Developmental Profile™ Infant-Toddler Checklist (CSBS-DP-IT) Social Composite, and the Rett Syndrome Clinician Rating of Ability to Communicate Choices (RTT-COMC). Results: Higher trofinetide exposure was associated with improvements in RSBQ, CSBS-DP-IT Social Composite, and RTT-COMC scores. Assuming target trofinetide AUC Conclusion: E-R efficacy modeling demonstrated significant relationships between trofinetide exposure and RSBQ, CSBS-DP-IT Social Composite, and RTT-COMC scores. Trofinetide is efficacious within the target exposure range, supporting the approved dosing regimen for trofinetide. Trial registration: NCT01703533, NCT02715115, NCT04181723.
MeSH term(s)	Humans ; Infant ; Bayes Theorem ; Communication ; Glutamates/therapeutic use ; Rett Syndrome/drug therapy
Chemical Substances	Glutamates ; trofinetide (Z2ME8F52QL)
Language	English
Publishing date	2024-02-16
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-024-02796-y
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Article ; Online: Progress and promise of antisense oligonucleotide therapeutics for central nervous system diseases.

Bishop, Kathie M

Neuropharmacology

2017 Volume 120, Page(s) 56–62

Abstract: Antisense oligonucleotide (ASO) drugs are an emerging class of therapeutics that have recently demonstrated progress and promise to treat diseases of the central nervous system (CNS). ASOs for a variety of targets and mechanisms are currently being ... ...

Abstract	Antisense oligonucleotide (ASO) drugs are an emerging class of therapeutics that have recently demonstrated progress and promise to treat diseases of the central nervous system (CNS). ASOs for a variety of targets and mechanisms are currently being investigated in clinical trials and pre-clinically for a number of CNS diseases. This review examines the available data regarding central ASO delivery, distribution, pharmacokinetics, pharmacodynamics and therapeutic opportunities. This article is part of the Special Issue entitled "Beyond small molecules for neurological disorders".
MeSH term(s)	Animals ; Central Nervous System Agents/pharmacology ; Central Nervous System Agents/therapeutic use ; Central Nervous System Diseases/drug therapy ; Drug Delivery Systems ; Humans ; Oligodeoxyribonucleotides, Antisense/pharmacology ; Oligodeoxyribonucleotides, Antisense/therapeutic use
Chemical Substances	Central Nervous System Agents ; Oligodeoxyribonucleotides, Antisense
Language	English
Publishing date	2017-07-01
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	218272-5
ISSN	1873-7064 ; 0028-3908
ISSN (online)	1873-7064
ISSN	0028-3908
DOI	10.1016/j.neuropharm.2016.12.015
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Article: Local Drug Delivery for the Treatment of Neurotology Disorders.

Piu, Fabrice / Bishop, Kathie M

Frontiers in cellular neuroscience

2019 Volume 13, Page(s) 238

Abstract: Neurotology disorders such as vertigo, tinnitus, and hearing loss affect a significant proportion of the population (estimated 39 million in the United States with moderate to severe symptoms). Yet no pharmacological treatments have been developed, in ... ...

Abstract	Neurotology disorders such as vertigo, tinnitus, and hearing loss affect a significant proportion of the population (estimated 39 million in the United States with moderate to severe symptoms). Yet no pharmacological treatments have been developed, in part due to limitations in effective drug delivery to the anatomically protected inner ear compartment. Intratympanic delivery, a minimally invasive injection performed in the office setting, offers a potential direct route of administration. Currently, off-label use of therapeutics approved to treat disorders via systemic administration are being injected intratympanically, mostly in the form of aqueous solutions, but provide variable levels of drug exposure for a limited time requiring repeated injections. Hence, current drug delivery approaches for neurotology disorders are sub-optimal. This review, following a description of pharmacokinetic considerations of the inner ear, explores the merits of novel delivery approaches toward the treatment of neurotology disorders. Methodologies employing local delivery to the inner ear are described, including direct intracochlear delivery as well as intratympanic methods of infusion and injection. Intratympanic injection delivery formulation strategies including hydrogels, polymers and nanoparticulate systems are explored. These approaches represent progress toward more effective delivery options for the clinical treatment of a variety of neurotology disorders.
Language	English
Publishing date	2019-06-03
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2452963-1
ISSN	1662-5102
ISSN	1662-5102
DOI	10.3389/fncel.2019.00238
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Article: Development of trofinetide for the treatment of Rett syndrome: from bench to bedside.

Kennedy, Melissa / Glass, Larry / Glaze, Daniel G / Kaminsky, Steve / Percy, Alan K / Neul, Jeffrey L / Jones, Nancy E / Tropea, Daniela / Horrigan, Joseph P / Nues, Paige / Bishop, Kathie M / Youakim, James M

Frontiers in pharmacology

2024 Volume 14, Page(s) 1341746

Abstract: Rett syndrome (RTT) is rare neurodevelopmental disorder caused by mutations in ... ...

Abstract	Rett syndrome (RTT) is rare neurodevelopmental disorder caused by mutations in the
Language	English
Publishing date	2024-01-22
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2023.1341746
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Article ; Online: Motor milestone assessment of infants with spinal muscular atrophy using the hammersmith infant neurological Exam-Part 2: Experience from a nusinersen clinical study.

Bishop, Kathie M / Montes, Jacqueline / Finkel, Richard S

Muscle & nerve

2017 Volume 57, Issue 1, Page(s) 142–146

Abstract: Introduction: In this study we examined the feasibility of assessing motor milestone performance of infants with spinal muscular atrophy (SMA) using the Hammersmith Infant Neurological Exam-Part 2 (HINE-2) in a phase 2 study of nusinersen.: Methods: ... ...

Abstract	Introduction: In this study we examined the feasibility of assessing motor milestone performance of infants with spinal muscular atrophy (SMA) using the Hammersmith Infant Neurological Exam-Part 2 (HINE-2) in a phase 2 study of nusinersen. Methods: Nineteen SMA infants were assessed using the HINE-2 at baseline (≤7 months of age), and periodically up to 39 months of age. We evaluated whether the HINE-2 was feasible, reliable, and sensitive to change. Results: Motor milestone assessments in SMA infants were feasible using the HINE-2. Baseline test-retest reliability was excellent (R = 0.987; P < 0.0001). SMA infants were extremely low functioning at baseline and the HINE-2 was able to detect changes over time in 16 of 19 infants within all 8 domains. HINE-2 improvements were correlated with changes in other neuromuscular outcome measures. Conclusion: Results support the use of the HINE-2 motor milestone assessment in clinical trials of SMA infants. Muscle Nerve 57: 143-146, 2017.
MeSH term(s)	Child, Preschool ; Developmental Disabilities/pathology ; Disease Progression ; Female ; Humans ; Infant ; Male ; Movement ; Neurologic Examination/methods ; Observer Variation ; Oligonucleotides/therapeutic use ; Reference Standards ; Reproducibility of Results ; Sensitivity and Specificity ; Spinal Muscular Atrophies of Childhood/drug therapy ; Spinal Muscular Atrophies of Childhood/pathology
Chemical Substances	Oligonucleotides ; nusinersen (5Z9SP3X666)
Language	English
Publishing date	2017-06-14
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study
ZDB-ID	438353-9
ISSN	1097-4598 ; 0148-639X
ISSN (online)	1097-4598
ISSN	0148-639X
DOI	10.1002/mus.25705
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Article ; Online: Spinal Muscular Atrophy Type I: Is It Ethical to Standardize Supportive Care Intervention in Clinical Trials?

Finkel, Richard S / Bishop, Kathie M / Nelson, Robert M

Journal of child neurology

2017 Volume 32, Issue 2, Page(s) 155–160

Abstract: The natural history of spinal muscular atrophy type I (SMA-I) has changed as improved medical support has become available. With investigational drugs for spinal muscular atrophy now in clinical trials, efficient trial design focuses on enrolling ... ...

Abstract	The natural history of spinal muscular atrophy type I (SMA-I) has changed as improved medical support has become available. With investigational drugs for spinal muscular atrophy now in clinical trials, efficient trial design focuses on enrolling recently diagnosed infants, providing best available supportive care, and minimizing subject variation. The quandary has arisen whether it is ethically appropriate to specify a predefined level of nutritional and/or ventilation support for spinal muscular atrophy type I subjects while participating in these studies. We conducted a survey at 2 spinal muscular atrophy investigator meetings involving physician investigators, clinical evaluators, and study coordinators from North America, Europe, and Asia-Pacific. Each group endorsed the concept that having a predefined degree of nutritional and ventilation support was warranted in this context. We discuss how autonomy, beneficence/non-maleficence, noncoercion, social benefit, and equipoise can be maintained when a predefined level of supportive care is proposed, for participation in a clinical trial.
Language	English
Publishing date	2017
Publishing country	United States
Document type	Journal Article
ZDB-ID	639288-x
ISSN	1708-8283 ; 0883-0738
ISSN (online)	1708-8283
ISSN	0883-0738
DOI	10.1177/0883073816671236
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Article ; Online: Trofinetide Treatment Demonstrates a Benefit Over Placebo for the Ability to Communicate in Rett Syndrome.

Neul, Jeffrey L / Percy, Alan K / Benke, Timothy A / Berry-Kravis, Elizabeth M / Glaze, Daniel G / Peters, Sarika U / Marsh, Eric D / An, Di / Bishop, Kathie M / Youakim, James M

Pediatric neurology

2023 Volume 152, Page(s) 63–72

Abstract: Background: Trofinetide was approved by the US Food and Drug Administration for the treatment of Rett syndrome (RTT) in March 2023. Benefiting the ability to communicate in RTT is often identified as the most important caregiver goal for new therapies. ... ...

Abstract	Background: Trofinetide was approved by the US Food and Drug Administration for the treatment of Rett syndrome (RTT) in March 2023. Benefiting the ability to communicate in RTT is often identified as the most important caregiver goal for new therapies. This analysis reports the communication-related end points from the phase 3 LAVENDER study of trofinetide in RTT. Methods: Females with RTT, aged five to 20 years, were randomized 1:1 to trofinetide or placebo for 12 weeks. Secondary efficacy end points related to communication were based on change from baseline to week 12 and included the caregiver-rated Communication and Symbolic Behavior Scales Developmental Profile™ Infant-Toddler Checklist (CSBS-DP-IT) Social Composite score (key secondary end point; scores ranged from 0 to 26 [higher scores indicated better communication]) and novel clinician rating scales (0 [normal] to 7 [severe impairment]) measuring the ability to communicate choices nonverbally (RTT-COMC) and verbally (RTT-VCOM). Results: Trofinetide demonstrated a statistically significant difference versus placebo for the CSBS-DP-IT Social Composite score (least squares mean [LSM] difference = 1.0; 95% confidence interval [CI], 0.3 to 1.7; P = 0.0064; Cohen's d effect size = 0.43) and a nominally significant difference for the RTT-COMC (LSM difference: -0.3; 95% CI, -0.6 to -0.0; P = 0.0257; Cohen's d effect size = 0.36). As expected, there was no difference for the RTT-VCOM. Conclusions: Significant treatment benefit for trofinetide versus placebo was observed in scales measuring the ability to communicate. These scales may be appropriate for future clinical studies in RTT and other neurodevelopmental disorders.
MeSH term(s)	United States ; Female ; Infant ; Humans ; Rett Syndrome/drug therapy ; Glutamates ; Caregivers
Chemical Substances	trofinetide (Z2ME8F52QL) ; Glutamates
Language	English
Publishing date	2023-11-23
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	639164-3
ISSN	1873-5150 ; 0887-8994
ISSN (online)	1873-5150
ISSN	0887-8994
DOI	10.1016/j.pediatrneurol.2023.11.005
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Article ; Online: Trofinetide for the treatment of Rett syndrome: a randomized phase 3 study.

Neul, Jeffrey L / Percy, Alan K / Benke, Timothy A / Berry-Kravis, Elizabeth M / Glaze, Daniel G / Marsh, Eric D / Lin, Tim / Stankovic, Serge / Bishop, Kathie M / Youakim, James M

Nature medicine

2023 Volume 29, Issue 6, Page(s) 1468–1475

Abstract: Rett syndrome is a rare, genetic neurodevelopmental disorder. Trofinetide is a synthetic analog of glycine-proline-glutamate, the N-terminal tripeptide of the insulin-like growth factor 1 protein, and has demonstrated clinical benefit in phase 2 studies ... ...

Abstract	Rett syndrome is a rare, genetic neurodevelopmental disorder. Trofinetide is a synthetic analog of glycine-proline-glutamate, the N-terminal tripeptide of the insulin-like growth factor 1 protein, and has demonstrated clinical benefit in phase 2 studies in Rett syndrome. In this phase 3 study ( https://clinicaltrials.gov identifier NCT04181723 ), females with Rett syndrome received twice-daily oral trofinetide (n = 93) or placebo (n = 94) for 12 weeks. For the coprimary efficacy endpoints, least squares mean (LSM) change from baseline to week 12 in the Rett Syndrome Behaviour Questionnaire for trofinetide versus placebo was -4.9 versus -1.7 (P = 0.0175; Cohen's d effect size, 0.37), and LSM Clinical Global Impression-Improvement at week 12 was 3.5 versus 3.8 (P = 0.0030; effect size, 0.47). For the key secondary efficacy endpoint, LSM change from baseline to week 12 in the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist Social Composite score was -0.1 versus -1.1 (P = 0.0064; effect size, 0.43). Common treatment-emergent adverse events included diarrhea (80.6% for trofinetide versus 19.1% for placebo), which was mostly mild to moderate in severity. Significant improvement for trofinetide compared with placebo was observed for the coprimary efficacy endpoints, suggesting that trofinetide provides benefit in treating the core symptoms of Rett syndrome.
MeSH term(s)	Female ; Humans ; Rett Syndrome/drug therapy ; Treatment Outcome ; Glutamates ; Double-Blind Method
Chemical Substances	trofinetide (Z2ME8F52QL) ; Glutamates
Language	English
Publishing date	2023-06-08
Publishing country	United States
Document type	Clinical Trial, Phase III ; Randomized Controlled Trial ; Journal Article
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-023-02398-1
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Article ; Online: Treatment of infantile-onset spinal muscular atrophy with nusinersen: final report of a phase 2, open-label, multicentre, dose-escalation study.

Finkel, Richard S / Chiriboga, Claudia A / Vajsar, Jiri / Day, John W / Montes, Jacqueline / De Vivo, Darryl C / Bishop, Kathie M / Foster, Richard / Liu, Yingying / Ramirez-Schrempp, Daniela / Schneider, Eugene / Bennett, C Frank / Wong, Janice / Farwell, Wildon

The Lancet. Child & adolescent health

2021 Volume 5, Issue 7, Page(s) 491–500

Abstract: Background: Nusinersen showed a favourable benefit-risk profile in participants with infantile-onset spinal muscular atrophy at the interim analysis of a phase 2 clinical study. We present the study's final analysis, assessing the efficacy and safety of ...

Abstract	Background: Nusinersen showed a favourable benefit-risk profile in participants with infantile-onset spinal muscular atrophy at the interim analysis of a phase 2 clinical study. We present the study's final analysis, assessing the efficacy and safety of nusinersen over 3 years. Methods: This phase 2, open-label, multicentre, dose-escalation study was done in three university hospital sites in the USA and one in Canada. Infants aged between 3 weeks and 6 months with two or three SMN2 gene copies and infantile-onset spinal muscular atrophy were eligible for inclusion. Eligible participants received multiple intrathecal loading doses of 6 mg equivalent nusinersen (cohort 1) or 12 mg dose equivalent (cohort 2), followed by maintenance doses of 12 mg equivalent nusinersen. The protocol amendment on Jan 25, 2016, changed the primary efficacy endpoint from safety and tolerability to reaching motor milestones, assessed using the Hammersmith Infant Neurological Examination section 2 (HINE-2) at the last study visit, in all participants who successfully completed the loading dose period and day 92 assessment. The statistical analysis plan was amended on Feb 10, 2016, to include additional analyses of the subgroup of participants with two SMN2 copies. Adverse events were assessed in all participants who received at least one dose of study treatment. The study is registered at ClinicalTrials.gov (NCT01839656). Findings: Between May 3, 2013, and July 9, 2014, 20 symptomatic participants with infantile-onset spinal muscular atrophy (12 boys and 8 girls; median age at diagnosis 78 days [range 0-154]) were enrolled. Median time on study was 36·2 months (IQR 20·6-41·3). The primary endpoint of an incremental improvement in HINE-2 developmental motor milestones was reached by 12 (63%) of 19 evaluable participants. In the 13 participants with two SMN2 copies treated with 12 mg nusinersen, the HINE-2 motor milestone total score increased steadily from a baseline mean of 1·46 (SD 0·52) to 11·86 (6·18) at day 1135, representing a clinically significant change of 10·43 (6·05). At study closure (Aug 21, 2017), 15 (75%) of 20 participants were alive. 101 serious adverse events were reported in 16 (80%) of 20 participants; all five deaths (one in cohort 1 and four in cohort 2) were likely to be related to spinal muscular atrophy disease progression. Interpretation: Our findings are consistent with other trials of nusinersen and show improved survival and attainment of motor milestones over 3 years in patients with infantile-onset spinal muscular atrophy, with a favourable safety profile. Funding: Biogen and Ionis Pharmaceuticals.
MeSH term(s)	Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Humans ; Infant ; Male ; Muscular Atrophy, Spinal/drug therapy ; Muscular Atrophy, Spinal/pathology ; Oligonucleotides/administration & dosage ; Oligonucleotides/therapeutic use ; Ontario ; Treatment Outcome ; United States
Chemical Substances	Oligonucleotides ; nusinersen (5Z9SP3X666)
Language	English
Publishing date	2021-06-03
Publishing country	England
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ISSN	2352-4650
ISSN (online)	2352-4650
DOI	10.1016/S2352-4642(21)00100-0
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