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Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial

SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excelle...

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Autores principales: Brownstein, Michael J., Simon, Neal G., Long, Jeffrey D., Yankey, Jon, Maibach, Hilda T., Cudkowicz, Merit, Coffey, Christopher, Conwit, Robin A., Lungu, Codrin, Anderson, Karen E., Hersch, Steven M., Ecklund, Dixie J., Damiano, Eve M., Itzkowitz, Debra E., Lu, Shifang, Chase, Marianne K., Shefner, Jeremy M., McGarry, Andrew, Thornell, Brenda, Gladden, Catherine, Costigan, Michele, O’Suilleabhain, Padraig, Marshall, Frederick J., Chesire, Amy M., Deritis, Paul, Adams, Jamie L., Hedera, Peter, Lowen, Kelly, Rosas, H. Diana, Hiller, Amie L., Quinn, Joseph, Keith, Kellie, Duker, Andrew P., Gruenwald, Christina, Molloy, Angela, Jacob, Cara, Factor, Stewart, Sperin, Elaine, Bega, Danny, Brown, Zsazsa R., Seeberger, Lauren C., Sung, Victor W., Benge, Melanie, Kostyk, Sandra K., Daley, Allison M., Perlman, Susan, Suski, Valerie, Conlon, Patricia, Barrett, Matthew J., Lowenhaupt, Stephanie, Quigg, Mark, Perlmutter, Joel S., Wright, Brenton A., Most, Elaine, Schwartz, Guy J., Lamb, Jessica, Chuang, Rosalind S., Singer, Carlos, Marder, Karen, Moran, Joyce A., Singleton, John R., Zorn, Meghan, Wall, Paola V., Dubinsky, Richard M., Gray, Carolyn, Drazinic, Carolyn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696926/
https://www.ncbi.nlm.nih.gov/pubmed/33207828
http://dx.doi.org/10.3390/jcm9113682
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author Brownstein, Michael J.
Simon, Neal G.
Long, Jeffrey D.
Yankey, Jon
Maibach, Hilda T.
Cudkowicz, Merit
Coffey, Christopher
Conwit, Robin A.
Lungu, Codrin
Anderson, Karen E.
Hersch, Steven M.
Ecklund, Dixie J.
Damiano, Eve M.
Itzkowitz, Debra E.
Lu, Shifang
Chase, Marianne K.
Shefner, Jeremy M.
McGarry, Andrew
Thornell, Brenda
Gladden, Catherine
Costigan, Michele
O’Suilleabhain, Padraig
Marshall, Frederick J.
Chesire, Amy M.
Deritis, Paul
Adams, Jamie L.
Hedera, Peter
Lowen, Kelly
Rosas, H. Diana
Hiller, Amie L.
Quinn, Joseph
Keith, Kellie
Duker, Andrew P.
Gruenwald, Christina
Molloy, Angela
Jacob, Cara
Factor, Stewart
Sperin, Elaine
Bega, Danny
Brown, Zsazsa R.
Seeberger, Lauren C.
Sung, Victor W.
Benge, Melanie
Kostyk, Sandra K.
Daley, Allison M.
Perlman, Susan
Suski, Valerie
Conlon, Patricia
Barrett, Matthew J.
Lowenhaupt, Stephanie
Quigg, Mark
Perlmutter, Joel S.
Wright, Brenton A.
Most, Elaine
Schwartz, Guy J.
Lamb, Jessica
Chuang, Rosalind S.
Singer, Carlos
Marder, Karen
Moran, Joyce A.
Singleton, John R.
Zorn, Meghan
Wall, Paola V.
Dubinsky, Richard M.
Gray, Carolyn
Drazinic, Carolyn
author_facet Brownstein, Michael J.
Simon, Neal G.
Long, Jeffrey D.
Yankey, Jon
Maibach, Hilda T.
Cudkowicz, Merit
Coffey, Christopher
Conwit, Robin A.
Lungu, Codrin
Anderson, Karen E.
Hersch, Steven M.
Ecklund, Dixie J.
Damiano, Eve M.
Itzkowitz, Debra E.
Lu, Shifang
Chase, Marianne K.
Shefner, Jeremy M.
McGarry, Andrew
Thornell, Brenda
Gladden, Catherine
Costigan, Michele
O’Suilleabhain, Padraig
Marshall, Frederick J.
Chesire, Amy M.
Deritis, Paul
Adams, Jamie L.
Hedera, Peter
Lowen, Kelly
Rosas, H. Diana
Hiller, Amie L.
Quinn, Joseph
Keith, Kellie
Duker, Andrew P.
Gruenwald, Christina
Molloy, Angela
Jacob, Cara
Factor, Stewart
Sperin, Elaine
Bega, Danny
Brown, Zsazsa R.
Seeberger, Lauren C.
Sung, Victor W.
Benge, Melanie
Kostyk, Sandra K.
Daley, Allison M.
Perlman, Susan
Suski, Valerie
Conlon, Patricia
Barrett, Matthew J.
Lowenhaupt, Stephanie
Quigg, Mark
Perlmutter, Joel S.
Wright, Brenton A.
Most, Elaine
Schwartz, Guy J.
Lamb, Jessica
Chuang, Rosalind S.
Singer, Carlos
Marder, Karen
Moran, Joyce A.
Singleton, John R.
Zorn, Meghan
Wall, Paola V.
Dubinsky, Richard M.
Gray, Carolyn
Drazinic, Carolyn
author_sort Brownstein, Michael J.
collection PubMed
description SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington’s disease (HD) patients with irritability. Our goal was to determine whether SRX246 was safe and well tolerated in these HD patients given its potential use for the treatment of problematic neuropsychiatric symptoms. Participants were randomized to receive placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246. Assessments included standard safety tests, the Unified Huntington’s Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors. The groups had comparable demographics, features of HD and baseline irritability. Eighty-two out of 106 subjects randomized completed the trial on their assigned dose of drug. One-sided exact-method confidence interval tests were used to reject the null hypothesis of inferior tolerability or safety for each dose group vs. placebo. Apathy and suicidality were not affected by SRX246. Most adverse events in the active arms were considered unlikely to be related to SRX246. The compound was safe and well tolerated in HD patients and can be moved forward as a candidate to treat irritability and aggression.
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spelling pubmed-76969262020-11-29 Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial Brownstein, Michael J. Simon, Neal G. Long, Jeffrey D. Yankey, Jon Maibach, Hilda T. Cudkowicz, Merit Coffey, Christopher Conwit, Robin A. Lungu, Codrin Anderson, Karen E. Hersch, Steven M. Ecklund, Dixie J. Damiano, Eve M. Itzkowitz, Debra E. Lu, Shifang Chase, Marianne K. Shefner, Jeremy M. McGarry, Andrew Thornell, Brenda Gladden, Catherine Costigan, Michele O’Suilleabhain, Padraig Marshall, Frederick J. Chesire, Amy M. Deritis, Paul Adams, Jamie L. Hedera, Peter Lowen, Kelly Rosas, H. Diana Hiller, Amie L. Quinn, Joseph Keith, Kellie Duker, Andrew P. Gruenwald, Christina Molloy, Angela Jacob, Cara Factor, Stewart Sperin, Elaine Bega, Danny Brown, Zsazsa R. Seeberger, Lauren C. Sung, Victor W. Benge, Melanie Kostyk, Sandra K. Daley, Allison M. Perlman, Susan Suski, Valerie Conlon, Patricia Barrett, Matthew J. Lowenhaupt, Stephanie Quigg, Mark Perlmutter, Joel S. Wright, Brenton A. Most, Elaine Schwartz, Guy J. Lamb, Jessica Chuang, Rosalind S. Singer, Carlos Marder, Karen Moran, Joyce A. Singleton, John R. Zorn, Meghan Wall, Paola V. Dubinsky, Richard M. Gray, Carolyn Drazinic, Carolyn J Clin Med Article SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington’s disease (HD) patients with irritability. Our goal was to determine whether SRX246 was safe and well tolerated in these HD patients given its potential use for the treatment of problematic neuropsychiatric symptoms. Participants were randomized to receive placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246. Assessments included standard safety tests, the Unified Huntington’s Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors. The groups had comparable demographics, features of HD and baseline irritability. Eighty-two out of 106 subjects randomized completed the trial on their assigned dose of drug. One-sided exact-method confidence interval tests were used to reject the null hypothesis of inferior tolerability or safety for each dose group vs. placebo. Apathy and suicidality were not affected by SRX246. Most adverse events in the active arms were considered unlikely to be related to SRX246. The compound was safe and well tolerated in HD patients and can be moved forward as a candidate to treat irritability and aggression. MDPI 2020-11-16 /pmc/articles/PMC7696926/ /pubmed/33207828 http://dx.doi.org/10.3390/jcm9113682 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Brownstein, Michael J.
Simon, Neal G.
Long, Jeffrey D.
Yankey, Jon
Maibach, Hilda T.
Cudkowicz, Merit
Coffey, Christopher
Conwit, Robin A.
Lungu, Codrin
Anderson, Karen E.
Hersch, Steven M.
Ecklund, Dixie J.
Damiano, Eve M.
Itzkowitz, Debra E.
Lu, Shifang
Chase, Marianne K.
Shefner, Jeremy M.
McGarry, Andrew
Thornell, Brenda
Gladden, Catherine
Costigan, Michele
O’Suilleabhain, Padraig
Marshall, Frederick J.
Chesire, Amy M.
Deritis, Paul
Adams, Jamie L.
Hedera, Peter
Lowen, Kelly
Rosas, H. Diana
Hiller, Amie L.
Quinn, Joseph
Keith, Kellie
Duker, Andrew P.
Gruenwald, Christina
Molloy, Angela
Jacob, Cara
Factor, Stewart
Sperin, Elaine
Bega, Danny
Brown, Zsazsa R.
Seeberger, Lauren C.
Sung, Victor W.
Benge, Melanie
Kostyk, Sandra K.
Daley, Allison M.
Perlman, Susan
Suski, Valerie
Conlon, Patricia
Barrett, Matthew J.
Lowenhaupt, Stephanie
Quigg, Mark
Perlmutter, Joel S.
Wright, Brenton A.
Most, Elaine
Schwartz, Guy J.
Lamb, Jessica
Chuang, Rosalind S.
Singer, Carlos
Marder, Karen
Moran, Joyce A.
Singleton, John R.
Zorn, Meghan
Wall, Paola V.
Dubinsky, Richard M.
Gray, Carolyn
Drazinic, Carolyn
Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
title Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
title_full Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
title_fullStr Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
title_full_unstemmed Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
title_short Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington’s Disease Patients—A Randomized Phase 2 Clinical Trial
title_sort safety and tolerability of srx246, a vasopressin 1a antagonist, in irritable huntington’s disease patients—a randomized phase 2 clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7696926/
https://www.ncbi.nlm.nih.gov/pubmed/33207828
http://dx.doi.org/10.3390/jcm9113682
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