tisolagiline (KDS-2010) / Sorrento, Biomed Industries - LARVOL DELTA

Astrocytic monoamine oxidase B (MAOB)-gamma-aminobutyric acid (GABA) axis as a molecular brake on repair following spinal cord injury. (PubMed, Signal Transduct Target Ther) - "This pathway therefore represents a pivotal target for overcoming the intrinsic barriers to CNS repair after injury. Our findings identify the astrocytic MAOB‒GABA axis as a crucial molecular and cellular brake on the CNS repair system following SCI and highlight the translational potential of KDS2010 as a promising therapeutic candidate for SCI treatment."

Journal • CNS Disorders • Orthopedics • BDNF • NTRK2

Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: NeuroBiogen Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Study to Evaluate the Efficacy and Safety of KDS2010 in Patients With Alzheimer's Disease With Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: NeuroBiogen Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Astrocytic gamma-aminobutyric acid dysregulation as a therapeutic target for posttraumatic stress disorder. (PubMed, Signal Transduct Target Ther) - "Our findings highlight the pivotal role of astrocytic GABA in PTSD pathophysiology and establish MAOB inhibition as a mechanistically targeted approach to alleviate symptoms. By bridging human and animal studies with translational clinical trials, this work positions KDS2010 as a promising first-in-class therapy, offering a novel paradigm for PTSD treatment."

Journal • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Study to Evaluate the Efficacy and Safety of KDS2010 in Patients With Alzheimer's Disease With Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: NeuroBiogen Co., Ltd

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: NeuroBiogen Co., Ltd

New P2 trial • Genetic Disorders • Obesity

Neurobiogen signs contract with U.S. pharmaceutical company to develop obesity and Alzheimer's disease treatment [Google translation] (Hankyung) - "Neurobiogen...announced on the 16th that it signed a global license and collaboration agreement with U.S. pharmaceutical company Scilex Bio Inc. for the development and commercialization of 'Tisolagiline (material name: KDS2010)', an oral treatment for obesity and Alzheimer's dementia...The contract is worth a total of 6.5 trillion won and includes upfront payment, milestones (stage-by-stage technology fees), and sales royalties. Of this, the upfront payment and milestones up to NDA (New Drug Application) amount to 70 billion won....If tisolagiline is commercialized, sales in the obesity treatment field are expected to reach approximately $13.5 billion in 2032, and in the dementia treatment field, approximately $300 billion in 2038."

Licensing / partnership • Sales projection • Alzheimer's Disease • Obesity

Biomarkers. (PubMed, Alzheimers Dement) - "We validated the effectiveness of the KDS2010 in APP/PS1 mice with a magnetic bead-based electrochemical sensor. Successful validation of a point-of-care platform for blood GFAP could increase the diagnostic reliability of AD, which could have a significant economic impact on the dementia diagnostics market."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Dementia • Movement Disorders • Parkinson's Disease • GFAP

NeuroBiogen Company and Scilex Bio, a Controlling Interest of Joint Venture by Scilex Holding Company enter into Binding Term Sheet for Worldwide License, Along with the Rights to Sublicense for All of KDS2010 indications; Binding Term Sheet Includes Collaboration for Development and Commercialization of Novel Oral Tablet KDS2010 in Ongoing Phase 2 CardioMetabolic and Neurodegenerative Diseases (GlobeNewswire) - "Scilex Bio...today announced the signing of a binding term sheet with NeuroBiogen ('NB') to grant Scilex Bio an exclusive worldwide license to the franchise KDS2010 drug candidate to develop and commercialize in metabolic diseases (including obesity and type 2 diabetes) and neurodegenerative diseases, including Alzheimer’s, Parkinson’s and other CNS diseases...The term sheet provides that NeuroBiogen will grant Scilex Bio the worldwide license rights along with the rights to sublicense for all KDS2010 indications."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Scilex Bio, a Controlling Interest of Joint Venture by Scilex Holding Company, Reports KDS2010 a Novel Oral Tablet Phase 2 Trial for Alzheimer’s Disease (AD) Currently Enrolling with U.S. Patient Cohort to be Added in 2025 (GlobeNewswire) - "Currently enrolling randomized, double-blind, placebo-controlled, dose-finding, Phase 2 clinical trial to evaluate the safety and efficacy of KDS2010 in patients with Alzheimer’s disease with mild cognitive impairment and mild dementia is currently recruiting in South Korea in 114 patients and U.S. cohort will be added in 2025."

Trial status • Alzheimer's Disease