Strada (ademetionine) / MSI Methylation Sciences - LARVOL DELTA

Pharmacokinetic study of a novel oral formulation of S-adenosylmethionine (MSI-195) in healthy subjects: dose escalation, food effect and comparison to a commercial nutritional supplement product. (PubMed, BMC Pharmacol Toxicol) - P1 | "The overall conclusion was that MSI-195 was well tolerated and has markedly higher bioavailability compared with both the SAM-e Complete™ commercial product tested and, on a per mg basis, products reported in other literature."

Clinical • Journal • PK/PD data

Evaluation of the Safety and Pharmacokinetics of MSI-195 to a Commercial S-Adenosylmethionine (clinicaltrials.gov) - P1; N=34; Completed; Sponsor: MSI Methylation Sciences, Inc.

Clinical • New P1 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

"La sola strada è ascoltare. E accogliere. E difendere. #dirittiumani #gender #trans @parislee @TheLancet ✨❤️ #TransRightsAreHumanRights @miofiglioinrosa @infogenderlens1" (@alswolf)

MSI Methylation Sciences, Inc. (MSI) provides an update on its corporate activities, including its recent arbitration award of $20 million USD against Quark Venture Inc (Quark) (GlobeNewswire) - "In September 2016 MSI and Quark jointly announced a $30 million USD investment to continue clinical development of MSI-195 for the treatment of depression. After making an initial payment of $1 million USD under the investment agreement, in November 2016 Quark declined to make any further payments. After being unable to resolve the matter with Quark, MSI initiated a binding arbitration proceeding against Quark....Quark, for its part, initiated a petition on August 20, 2018 to seek leave to appeal the award on the basis of certain alleged errors of law..."

Corporate lawsuit • CNS Disorders • Depression • Mood Disorders • Psychiatry

Early score fluctuation and placebo response in a study of major depressive disorder. (PubMed, J Psychiatr Res) - "We examined the effect of early score fluctuation during a 2-week double-blind placebo lead-in period in a phase II, double-blind, placebo-controlled trial of adjunctive s-adenosyl methionine (MSI-195) in MDD subjects who had had an inadequate response to ongoing antidepressant treatment. A reliable baseline measure is an asset for signal detection. These post-hoc findings suggest that study designs that anticipate and attempt to manage early response prior to randomization may yield more meaningful outcome data for trials of MDD and possibly other disorders as well."

Clinical • Journal

Novel Homozygous Deletion in STRADA Gene Associated With Polyhydramnios, Megalencephaly, and Epilepsy in 2 Siblings: Implications for Diagnosis and Treatment. (PubMed, J Child Neurol) - "The remaining individual is of consanguineous Indian descent and has a homozygous single-base pair duplication. We report a novel STRADA gene deletion of exons 7-9 in 2 sisters from nonconsanguineous parents, as well as an improvement in seizure control in 1 sibling following treatment with sirolimus, an m-Tor inhibitor of potential benefit to patients with this genetic mutation."

Journal

An augmentation study of MSI-195 (S-adenosylmethionine) in Major Depressive Disorder. (PubMed, J Psychiatr Res) - P2; "These post-hoc findings highlight the inherent challenges encountered for subject selection in double-blind, placebo controlled trials and compel further investigation of enrollment criteria and moderating factors that affect treatment. The favorable safety profile and clinical benefit observed with MSI-195 in the 1st half of this study warrant further investigation in MDD."

Journal