2025 ACCP Virtual Journal Club Webinar-March | Safety, Tolerability & Pharmacokinetics of Oral Doses of the Sirtuin 6 Activator SP-624 - Live
Includes a Live Web Event on 03/18/2025 at 12:00 PM (EDT)
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2025 ACCP Virtual Journal Club Webinar: - LIVE
Live Session: Tuesday, March 18th, 2025, from 12:00 to 1:00 PM ET
On Demand: March 18th, 2025 to March 18th, 2028
Why is this webinar important to your practice?
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other health care professionals, including Clinical Pharmacologists and Allied Health Services, who are involved or interested in the dosing of Sirtuin 6 Activator SP-624.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the pharmacokinetics of SP-62;
- Identify key characteristics of dose estimation via ascending dose response of Sirtuin 6 Activator;
- Describe the safety assessments based on the adverse events, serious adverse events and treatment emergent adverse events (TEAEs) of Sirtuin 6 Activator;
- Discuss the use of pharmacokinetics in early drug development.
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Greg Rigdon
Sr VP, Scientific Affairs
Arrivo Bioventures
Dr. Greg Rigdon is Senior Vice President of Scientific Affairs at Arrivo Bioventures. Greg’s drug development experience includes discovery through phase 4 clinical trials and his regulatory experience includes IND and NDA filings. He has over 30 years experience in the industry from running a neuropharmacology laboratory at Burroughs Wellcome to managing clinical development teams at Glazo Wellcome and Icagen to serving as a clinical pharmacology consultant. He has experience in multiple therapeutic areas: psychiatry, neurology, sickle cell disease, preeclampsia and multiple GI indications. In his current role he manages the nonclinical aspects of drug development, interacts with regulatory authorities and designs clinical trials.
Greg has authored/co-authored over 30 journal articles in pharmacology, neuroscience and clinical research. He is also an inventor with multiple patents and has guest lectured at the University of North Carolina at Chapel Hill, North Carolina State University and Campbell University. Greg earned his Ph.D. in Pharmacology from Texas Tech University Health Sciences Center in 1985.
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William Wargin
Pharmacokineticist
Sirtsei Pharmaceuticals, Inc
Dr. Wargin has over 20 years of experience as a pharmacokineticist, having worked with 60+ small and large pharmaceutical companies developing drugs in several therapeutic areas including CNS, oncology, anti-viral, cardiovascular and metabolic disease. In this context, he has worked in nonclinical drug development including in-vitro and in-vivo metabolism and pharmacokinetics. During Phase 1 development, he participated in design and implementation of clinical pharmacology studies from first time in humans to bioequivalence studies for new formulations post-approval, partnered with CROs for protocol development, review and study conduct, and provided pharmacokinetic and PK/PD data analysis of data and report writing. Dr. Wargin has written several nonclinical ADME/PK sections of IND submissions and clinical pharmacology sections of NDAs in CTD format and has participated in 10+ pre-IND meetings in various therapeutic areas.
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Vatsalya Vatsalya (Moderator)
Assistant Professor of Medicine
Univ of Louisville
Dr. Vatsalya is an Assistant Professor of Medicine in the Department of Medicine at the University of Louisville in the Division of Gastroenterology, Hepatology, and Nutrition. He is also affiliated with the VA Robley Rex Medical Center as a clinical scientist. Dr. Vatsalya is trained as a physician, but his primary role is research and support for patients with their mental health conditions. He is an addiction specialist, licensed in addiction and mental health in Kentucky. He is a PI on medication trials on AUD, funded both institutionally and federally, including the National Institutes of Health. During his fellowship, he developed and validated the food-alcohol task, which is used widely in human neural-mechanistic-treatment studies (disease, and non-treatment-seeking cohorts). He has developed novel clinical paradigms to study treatment efficacy in various patient populations. Dr. Vatsalya has a novel drug registered with the US Patent and Trademark Office for the treatment of AUD-ALD as a dual-target therapy, licensing efforts and phase I preparation have been initiated. Notably, he was also in a group of addiction investigators that developed the WHO's ICD 11 code for alcohol hangover conditions. He has an independent clinical research lab and has several clinical publications in high-impact, prestigious-ranking national and international journals. He mentors several clinical trainees and clinical and non-clinical students.
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