KM-819 / Kainos Medicine - LARVOL DELTA

Astragalin actives autophagy and inhibits apoptosis of astrocytes in AD mice via down-regulating Fas/Fasl-VDAC1 pathway. (PubMed, Free Radic Biol Med) - "Additionally, AST inhibited the expression of proteins associated with the Fas/Fasl-VDAC1 signaling pathway, while autophagy inhibitor chloroquine (CQ) or apoptosis agonist phenoxodiol reversed above change. Interestingly, consistent with the action of pathway Fas inhibitor KR-33493, AST could activate autophagy of Aβ1-42 injured C8D1A cells while inhibit their apoptosis. In conclusion, AST activated autophagy and inhibited apoptosis of hippocampal astrocytes in AD mice, ameliorating animal cognitive deficits by down-regulating Fas/Fasl-VDAC1 signaling pathway. Thus, this study provided a new perspective and experimental foundation for developing AD treatment drugs."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Oncology • FASLG • VDAC1

Kainos, MSA domestic clinical trial in progress… Expanding to preventive treatment as well [google translation] (Medipana) - P2 | N=68 | NCT05695378 | Sponsor: Kainos Medicine Inc. | "According to Kainosmed on the 12th, the MSA domestic phase 2 clinical trial plans to resume by having patients who participated in the existing clinical trial participate in the screening again. The related documents are currently being organized and will be submitted to the Ministry of Food and Drug Safety after completion to resume...According to the domestic clinical trial results announced by the company, after 9 months of drug administration, the placebo group showed a tendency for glucose metabolism to decrease, but the KM-819 treatment group showed no decrease in glucose metabolism and was similar to before administration...In addition to its potential as an MSA treatment, the company expects that it will also have a high therapeutic effect in PD based on various evaluation indicators."

Clinical • P2 data • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Kainosmed, Parkinson’s and MSA are under investigation by 4 US investment institutions with high interest [Google translation] (Hankyung) - "Kainos Medicine announced on the 14th that it is conducting due diligence with four top-tier U.S. institutional investors based on the confirmation of proof of concept in clinical trials for its innovative new drug 'KM-819' for Parkinson's disease and multiple system atrophy (MSA). The clinical data announced by Kainos Medicine through its corporate briefing session is an analysis of the efficacy results following the lifting of the double-blind domestic phase 2 clinical trial of 'KM-819' for multiple system atrophy. Kainos Medicine commissioned an analysis by a third-party analysis agency to ensure the reliability of the clinical data and announced the results of the efficacy evaluation."

Commercial • P2 data • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA) (clinicaltrials.gov) - P2 | N=68 | Terminated | Sponsor: Kainos Medicine Inc. | Trial completion date: Nov 2024 ➔ Aug 2024 | Recruiting ➔ Terminated; Sponsor has decided to withdraw the study due to safety issue and re-initiate with a new clinical study

Trial completion date • Trial termination • CNS Disorders • Movement Disorders • Multiple System Atrophy

Kainosmed ’KM-819, MSA domestic phase 2 clinical trial voluntarily withdrawn… will reapply’ [Google translation] (The Bio) - "Kainosmed announced on the 19th that it has accepted the recommended procedures from the Ministry of Food and Drug Safety to resume the domestic phase 2 clinical trial for administering the drug (KM-819) to patients with multiple system atrophy (MSA) that began in March of last year...Accordingly, Kainosmed is doing its best to voluntarily withdraw the clinical trial under the recommendation of the Ministry of Food and Drug Safety and to restart the clinical trial as soon as possible...'We plan to analyze the efficacy data of all patients who participated in the clinical trial and were administered the drug, including the six who completed the nine-month master clinical trial, and announce the results soon.'"

Trial withdrawal • CNS Disorders • Multiple System Atrophy

A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease (clinicaltrials.gov) - P2 | N=314 | Active, not recruiting | Sponsor: FAScinate Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Rat Pharmacokinetics and In Vitro Metabolite Identification of KM-819, a Parkinson's Disease Candidate, Using LC-MS/MS and LC-HRMS. (PubMed, Molecules) - "Glucuronidation and mono-oxidation have been proposed as the major metabolic pathways. Overall, these findings contribute to a better understanding of the pharmacokinetic characteristics of KM-819, thereby aiding future clinical studies."

Journal • PK/PD data • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease • FAS

Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA) (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Kainos Medicine Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA) (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Kainos Medicine Inc.

New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

FAScinate Therapeutics Completes Part 1a of Phase 2 Study of Company's Parkinson’s Disease Drug Candidate "KM-819" (PRWeb) - “Clinical stage drug development company FAScinate Therapeutics, Inc. today announced the successful completion of Part 1a, the initial stage of Phase 2 studies, for the Company's Parkinson’s Disease drug candidate 'KM-819,' with the results showing a favorable safety profile….The subsequent stage, Part 1b, will be a dose-finding study of KM-819 in Parkinson’s Disease patients where the pharmacokinetics and safety profile will be evaluated at three doses, including a high dose tested in healthy test subjects. The results will then be used to select the doses used for the main Part 2 study, a 24-month trial of the selected doses evaluating both the safety and efficacy endpoints of KM-819 on the progression of Parkinson’s Disease.”

Trial status • CNS Disorders • Parkinson's Disease

A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease (clinicaltrials.gov) - P2 | N=330 | Recruiting | Sponsor: FAScinate Therapeutics Inc.

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

“Kainos Med expands indications for KM-819 multiple system atrophy (MSA) treatment” [Google translation] (Insight) - "Hana Securities announced on the 21st that the phase 2 clinical trial of KM-819 in the US is in full swing for Kainos Med....'Kainos Medicine is expected to start the first dose determination test through its subsidiary FAScinate in July, and the phase 2 clinical trial of KM-819 in the US is expected to begin in earnest'....'KM-819 is expected to enter phase 2 clinical trials in Korea in the first half of next year after confirming its efficacy in indications for multiple system atrophy, a rare neurodegenerative disease,' he said. It is expected that it will be used as positive data in clinical trials for Parkinson’s disease in the future.' 'Multiple system atrophy is classified as a rare disease, and conditional approval is expected to be possible if phase 2 clinical trials are successful.'"

New P2 trial • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Samsung Electronics “Kainos Medicine, Parkinson’s Disease Treatment KM-819 Targets Innovative New Drug” [Google Translation] (SEN Seoul Economy TV) - "Samsung Securities announced on the 23rd about Kainos Med, 'We are developing KM-819, which is scheduled to be the largest clinical trial for Parkinson’s disease, with the goal of developing an innovative new drug'....'Part 2 clinical trials are scheduled to be conducted for about 2 years from 2023 on 288 patients with Parkinson's disease. After proving efficacy in multiple system atrophy, we aim to enter phase 2 in Korea.' 'BIIB122 of Biogen/Denali, a representative pipeline for LRRK2 inhibition, entered phase 2b clinical trials in May and is scheduled to enter phase 3 in the fourth quarter of this year.'"

New P3 trial • New trial • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Kainosmed "Technology transfer royalties are increasing…Parkinson's disease treatment US Phase 2 clinical trial cruise" [Google translation] (Yakup Shinmoon) - "Currently, a treatment for Parkinson's disease (KM-819) is in phase 2 clinical trials in the US, and administration started on the 9th. A treatment for multiple system atrophy (MSA) indications (KM-819) is about to start phase 2 clinical trials in Korea in October."

Enrollment open • New P2 trial • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Kainos Med begins US phase 2 clinical trials for Parkinson's therapy (Korea Biomedical Review) - "Kainos Med said it would start phase 2 clinical trials in the U.S. by administering its Parkinson's disease treatment, KM-819, to subjects....The phase 2 clinical trial targeting Parkinson's disease will comprise two sub-phases. The first sub-phase, scheduled to begin in early August, will incrementally administer KM-819 in 200, 400, and 800mg doses to Parkinson's disease patients and general participants to determine the optimal dose. Once the dose is confirmed, drug administration will begin in 2023 for 288 Parkinson's disease patients in the U.S. in the second sub-phase in what is regarded as one of the largest clinical trials in the world."

New P2 trial • CNS Disorders • Parkinson's Disease

Kainosmed (284620) IPO organizer update: KM-819 expected to enter phase 2 clinical trial in the US in 2H [Google translation] (Maekyung Media Group) - "KinoSmed, a Parkinson’s disease treatment development company , is a Parkinson’s disease treatment research and development company, and is planning to enter the FDA phase 2 clinical trial for a Parkinson’s disease treatment (KM-819) in the second half of 2022. Currently, only symptom relievers for Parkinson's disease exist, so the demand for technology transfer is expected to increase when KM-819 starts and completes phase 2 clinical trials....Kainosmed is about to enter the US phase 2 clinical trial for KM-819 in the second half of this year.A trial to determine the primary dose is planned from July of this year, and administration is expected to begin in 2023 for patients with secondary Parkinson's disease."

New P2 trial • CNS Disorders • Parkinson's Disease

Kainos Med to start two phases in Korea and the US this year, will “increase corporate value” [Google translation] (Money Today Network (MTN)) - "According to the bio industry on the 13th, Kainosmed...will start the US phase 2 clinical trial of KM-819, which is being developed as a treatment for Parkinson's disease, this month. It has been five months since the US Food and Drug Administration (FDA) approved the clinical trial plan....Kainosmed plans to proceed with the KM-819 phase 2 clinical trial in two phases. The first step is to determine the appropriate dose by administering 200 mg, 400 mg, and 800 mg of KM-819 to 24 healthy and elderly participants and 24 patients with Parkinson's disease. The goal is to complete this this year. Once the dose is confirmed, clinical trials for 288 patients will be conducted at hospitals in the United States for two years..."

New P2 trial • Trial initiation date • CNS Disorders • Parkinson's Disease

Kainosmed patented KM-819 for Parkinson’s disease treatment in the US [Google translation] (Dementia News) - "Kainosmed announced on the 2nd that it had obtained a patent in the United States for a salt form that increased the solubility of 'KM-819'."

Patent • Patent • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Pharmacological Intervention Targeting FAF1 Restores Autophagic Flux for α-Synuclein Degradation in the Brain of a Parkinson's Disease Mouse Model. (PubMed, ACS Chem Neurosci) - "Consistently, KM-819 reduced α-synuclein accumulation in both the hippocampus and the midbrain of human A53T α-synuclein transgenic mice. Collectively, these data imply that KM-819 may have therapeutic potential for patients with PD."

Journal • Preclinical • CNS Disorders • Metabolic Disorders • Movement Disorders • Parkinson's Disease

"Kinosmed, 'attention' to enter the global phase 2 of 'KM-819' next year" [Google translation] (Maeil) - "Earlier in November, KM-819 received US FDA phase 2 clinical trial approval and plans to start phase 2 clinical trial in the first quarter of next year."

New P2 trial • CNS Disorders • Parkinson's Disease

FAScinate Therapeutics, Inc. Cleared for Phase 2 Clinical Trials of Company’s Parkinson’s Disease Treatment with Approval from U.S. Food and Drug Administration (PRWeb) - “Clinical stage drug development company FAScinate Therapeutics, Inc. today announced that its Investigational New Drug (IND) application for Phase 2 trials of its Parkinson’s Disease treatment “KM-819” has been cleared by the United States Food and Drug Administration (FDA). The trial design, as approved by the FDA, is intended to evaluate the disease-modifying efficacy of KM-819 in slowing or stopping the progression of Parkinson’s disease. The goal is to evaluate the pharmacokinetics and safety and preliminary efficacy in early to mid-stage patients, including GBA mutation carriers, with two-year treatments.”

IND • CNS Disorders • Parkinson's Disease

FAScinate Therapeutics Inc. Submits Investigational New Drug (IND) Application for Phase 2 Clinical Studies of Company's New Parkinson's Disease Treatment (PRWeb) - “FAScinate Therapeutics today announced that it has submitted an Investigational New Drug (IND) Application for Phase 2 clinical trials of its Parkinson's Disease drug candidate 'KM-819' to the U.S. Food and Drug Administration (FDA). KM-819 is an orally active small molecule that is a potentially disease-modifying treatment for Parkinson's Disease.”

IND • CNS Disorders • Parkinson's Disease

Kinosmed, Ministry of Food and Drug Safety ‘approved’ for phase 2 clinical trial for multiple system atrophy [Google translation] (MBN) - "Kainosmed announced on the 25th that it had received approval from the Ministry of Food and Drug Safety for a phase 2 clinical trial plan (IND) of a candidate substance (KM-819) for the treatment of multiple system atrophy (MSA), a rare degenerative brain disease (CNS) on the 22nd....has shown excellent efficacy in cell and animal models and high safety in phase 1 clinical trials. Phase 2 clinical trial is a test for actual patients and is a proof-of-concept (POC) test whose main purpose is to evaluate drug efficacy....This clinical trial is aimed at 78 patients with multiple system atrophy at Asan Medical Center, Seoul....Along with the Unified Multiple System Atrophy Rating Scale (UMSARS) questionnaire that judges clinical symptoms, FP-PET imaging technology...was applied to all patients. It was decided to be used for clinical efficacy evaluation."

New P2 trial • CNS Disorders • Multiple System Atrophy

Kainosmed submits IND for Parkinson's disease treatment phase 2 clinical trial to the US FDA [Google translation] (Money Today Network (MTN)) - "On the 18th, KinoSmed submitted a Phase 2 clinical trial plan (IND) for KM-819, a Parkinson's disease treatment, to the US Food and Drug Administration (FDA) through its subsidiary FAScinate Therapeutics (San Diego, USA)....Kainos Med plans to divide Phase 2 into two parts. First, it was decided to determine the appropriate dose by administering 200 mg, 400 mg, and 800 mg of KM819 to 24 healthy and elderly participants and 24 patients with Parkinson's disease, respectively. This reflects the recommendations made by the FDA at the pre-IND meeting last year. It was administered up to 400 mg in phase 1 clinical trial, according to the plan to conduct a clinical trial at a higher dose because there are no side effects. After the dose is decided, it is planned to be conducted for two years in 288 patients in hospitals in the United States."

IND • New P2 trial • CNS Disorders • Parkinson's Disease

Kynosmed ends phase 1b drug treatment for Parkinson's disease in the US [Google translation] (Hankyung) - "Kynosmed...announced on the 5th that it had ended the US clinical trial phase 1b drug administration of Parkinson's disease treatment KM-819 as scheduled. Phase 1b of the clinical trial was conducted by a subsidiary Facinate in eight healthy male adults for one month...Kynosmed plans to write a clinical report upon completion of phase 1b administration..."

Trial completion • CNS Disorders • Parkinson's Disease