KANSAS CITY, Kan., Jan. 9, 2018 /PRNewswire/ -- Cingulate Therapeutics LLC, a clinical stage biopharmaceutical company focused on the development of new and innovative products utilizing its precision timed release drug delivery platform technology, today announced the appointment of Matthew Brams, MD to the role of Chief Medical Officer (CMO). Dr. Brams is a Co-Founder of Cingulate Therapeutics and currently serves as a member of the Board of Directors.
Shane J. Schaffer, PharmD, Chairman and Chief Executive Officer of Cingulate Therapeutics, said, "Matt brings a wealth of clinical trial experience to our team as we work to optimize our regulatory plans for our lead product candidates CTX-1301 and CTX-1302. We now have the FDA's responses to our pre-IND package submissions and intend use this information to initiate and complete Phase I/II clinical trials for both assets in 2018. We also intend to begin Phase III trials this year, working via the accelerated 505(b)(2) new drug application pathway."
Dr. Brams said, "I've been working with Cingulate Therapeutics since its inception to assist in the design of its precision timed release drug delivery platform technology and believe this platform has excellent potential for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as well as other disorders. I'm excited to bring my expertise to the clinical trial strategy and execution for CTX-1301 and CTX-1302."
Dr. Brams has been a lead investigator in several pivotal trials involving drugs for the treatment of ADHD, autism, bipolar disorder and schizophrenia. He has extensive experience in drug development and execution of Phase I-IV trials. He has been involved in over 125 clinical trials in adult and pediatric populations in all areas of psychiatry. Dr. Brams has over 25 years of clinical experience managing patients in the field of Adult and Child Psychiatry with particular expertise in ADHD and Autistic Spectrum Disorders (ASD). Prior to taking the role of CMO at Cingulate, he held the position of Medical Director and Principal of Bayou City Research, Inc. where he has been instrumental in gaining FDA approval of over 15 Central Nervous System drugs currently prescribed for use in these patients.
Dr. Brams earned his MD from the University of Texas Health Science Center in Houston and completed his residencies at Baylor College of Medicine. He is also a Clinical Associate Professor at the Menninger Department of Psychiatry of Baylor College of Medicine and has published over 20 peer-reviewed journal articles. He is Board certified in Adult and Child Psychiatry and is a Senior Board Examiner for the American Board of Psychiatry and Neurology.
About Cingulate Therapeutics Cingulate Therapeutics LLC is a privately held clinical stage biopharmaceutical company focused on the development of new and innovative products utilizing the Company's innovative, precision timed release drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Cingulate is developing two proprietary, first-line stimulant medications, CTX-1301 (dexmethylphenidate) and CTX-1302 (dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTX-1301 and CTX-1302 utilize an innovative, flexible core tableting technology with a Target Product Profile designed to deliver a rapid onset and last the entire active day while providing a controlled descent of plasma drug levels to optimize treatment. The Company has completed a Proof of Concept Phase I clinical trial and plans to implement the full clinical plan for both CTX-1301 and CTX-1302 in 2018. Cingulate anticipates filing INDs for both assets in the second quarter of 2018 and will pursue approval via the accelerated 505(b)(2) regulatory pathway. The company has offices in Kansas City, KS and Morristown, NJ. For more information visit www.cingulatetherapeutics.com.
For Investors & Media:
Tiberend Strategic Advisors, Inc.Jonathon Brzezinski, Ph.D.: [email protected]; (212) 375-2681Janine McCargo: [email protected]; (646) 604-5150
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Shane J. Schaffer, PharmD, Chairman and Chief Executive Officer of Cingulate Therapeutics, said, "Matt brings a wealth of clinical trial experience to our team as we work to optimize our regulatory plans for our lead product candidates CTX-1301 and CTX-1302. We now have the FDA's responses to our pre-IND package submissions and intend use this information to initiate and complete Phase I/II clinical trials for both assets in 2018. We also intend to begin Phase III trials this year, working via the accelerated 505(b)(2) new drug application pathway."
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Dr. Brams said, "I've been working with Cingulate Therapeutics since its inception to assist in the design of its precision timed release drug delivery platform technology and believe this platform has excellent potential for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as well as other disorders. I'm excited to bring my expertise to the clinical trial strategy and execution for CTX-1301 and CTX-1302."
Dr. Brams has been a lead investigator in several pivotal trials involving drugs for the treatment of ADHD, autism, bipolar disorder and schizophrenia. He has extensive experience in drug development and execution of Phase I-IV trials. He has been involved in over 125 clinical trials in adult and pediatric populations in all areas of psychiatry. Dr. Brams has over 25 years of clinical experience managing patients in the field of Adult and Child Psychiatry with particular expertise in ADHD and Autistic Spectrum Disorders (ASD). Prior to taking the role of CMO at Cingulate, he held the position of Medical Director and Principal of Bayou City Research, Inc. where he has been instrumental in gaining FDA approval of over 15 Central Nervous System drugs currently prescribed for use in these patients.
Dr. Brams earned his MD from the University of Texas Health Science Center in Houston and completed his residencies at Baylor College of Medicine. He is also a Clinical Associate Professor at the Menninger Department of Psychiatry of Baylor College of Medicine and has published over 20 peer-reviewed journal articles. He is Board certified in Adult and Child Psychiatry and is a Senior Board Examiner for the American Board of Psychiatry and Neurology.
About Cingulate Therapeutics Cingulate Therapeutics LLC is a privately held clinical stage biopharmaceutical company focused on the development of new and innovative products utilizing the Company's innovative, precision timed release drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Cingulate is developing two proprietary, first-line stimulant medications, CTX-1301 (dexmethylphenidate) and CTX-1302 (dextroamphetamine), for the treatment of ADHD intended for all patient segments: children, adolescents, and adults. CTX-1301 and CTX-1302 utilize an innovative, flexible core tableting technology with a Target Product Profile designed to deliver a rapid onset and last the entire active day while providing a controlled descent of plasma drug levels to optimize treatment. The Company has completed a Proof of Concept Phase I clinical trial and plans to implement the full clinical plan for both CTX-1301 and CTX-1302 in 2018. Cingulate anticipates filing INDs for both assets in the second quarter of 2018 and will pursue approval via the accelerated 505(b)(2) regulatory pathway. The company has offices in Kansas City, KS and Morristown, NJ. For more information visit www.cingulatetherapeutics.com.
For Investors & Media:
Tiberend Strategic Advisors, Inc.Jonathon Brzezinski, Ph.D.: [email protected]; (212) 375-2681Janine McCargo: [email protected]; (646) 604-5150
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SOURCE Cingulate Therapeutics LLC
