KP405 / Kariya Pharma - LARVOL DELTA

Evaluating KP405, a CNS -penetrating GLP1/GIP analogue, in a randomized, placebo-controlled Phase I study in healthy elderly participants and Parkinson’s disease patients with exploratory analysis of biomarkers in brain-derived extracellular vesicles (MDS Congress 2026) - No abstract available

Biomarker • Clinical • Late-breaking abstract • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Kariya Pharmaceuticals | Recruiting ➔ Completed | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Kariya and NeuraLight Partner to Measure How Next-Generation GLP-1 Therapies Impact the Brain (Businesswire) - "The partnership integrates NeuraLight’s precision biomarker platform into Kariya’s Phase II program for KP405, a first-in-class brain-penetrant dual GLP-1/GIP agonist in development for Parkinson’s and Alzheimer’s disease. The NeuraLight platform uses its novel brain function biomarkers to quantify the neuroprotective effect of KP405....Under the new partnership, NeuraLight's platform will be integrated into Kariya's upcoming Phase II clinical trial to support objective, quantitative assessment of brain function."

Licensing / partnership • New P2 trial • Alzheimer's Disease • Parkinson's Disease

DUAL GLP-1/GIP RECEPTOR AGONISTS THAT CAN CROSS THE BBB SHOW SUPERIOR NEUROPROTECTIVE EFFECTS (ADPD 2025) - "Methods Bydureon (exenatide) and Adlyxin (lixisenatide) showed disease-modifying protective effects in patients with PD in two phase 2 clinical trials...NLY01, a pegylated form of exenatide that can't cross the BBB did not show any effects in PD patients in a phase 2 trial...Results Currently, two phase 3 trials are ongoing, testing the diabetes drug Ozempic/Wegovy (semaglutide) in AD patients...In animal models of AD or PD, dual agonists were able to protect neurons better than GLP-1 class drugs such as liraglutide, semaglutide or tirzepatide that were designed to treat diabetes and that stay in the blood for longer periods. Conclusions The dual GLP-1/GIP receptor agonist KP405 (DA5-CH) is currently in a phase 1 clinical trial and Results will be shared at the conference."

Alzheimer's Disease • CNS Disorders • Diabetes • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Kariya Pharmaceuticals | Not yet recruiting ➔ Recruiting

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

Korea BNC Investment Company Keriya 'GLP1-GIP Dual Agonist Single Dose Clinical Phase 1 Successfully Completed' [Google translation] (Health Korea News) - "Korea BNC...announced on the 17th that...Kariya...successfully completed the phase 1 single-dose escalation clinical trial without any notable safety issues. The company explained, 'The dosage for the 6th administration group is approximately 100 times higher than that of the 1st administration group,' and 'This phase 1 clinical trial will confirm the safety with a single administration dose and multiple administration dose that gradually increases from a low dose.'...Keriyasa plans to complete the Phase 1 single-dose followed by multiple-dose clinical trials by July 2025 and release the results report in August 2025."

P1 data • Trial status • CNS Disorders • Parkinson's Disease

Korea BNC introduces new Alzheimer's and Parkinson's disease drugs 'Safety confirmed in phase 1' [Google translation] (Health Korea News) - "Korea BNC announced on the 16th that Denmark's Kariya...completed dosing the first group of 8 subjects without any safety issues in the phase 1 clinical trial for 'KP405'...Keriya is conducting single-dose and multiple-dose clinical trials of 'KP405' through Phase 1 clinical trials, and aims to complete the trials by July 2025 and release a results report in August of the same year."

P1 data • Trial completion date • Trial status • CNS Disorders • Parkinson's Disease

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=88 | Not yet recruiting | Sponsor: Kariya Pharmaceuticals | Trial completion date: Mar 2025 ➔ Mar 2026 | Initiation date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=88 | Not yet recruiting | Sponsor: Kariya Pharmaceuticals

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

A Dual GLP-1/GIP Receptor Agonist Is More Effective than Liraglutide in the A53T Mouse Model of Parkinson's Disease. (PubMed, Parkinsons Dis) - "Here, we test liraglutide against the dual GLP-1/GIP agonist DA5-CH (KP405) in the A53T tg mouse model of PD which expresses a human-mutated gene of α-synuclein. Drug treatment reduced impairments in three different motor tests, reduced levels of α-syn in the substantia nigra, reduced the inflammation response and proinflammatory cytokine levels in the substantia nigra and striatum, and normalized biomarker levels of autophagy and mitochondrial activities in A53T mice. DA5-CH was superior in almost all parameters measured and therefore may be a better drug treatment for PD than liraglutide."

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

Draft Genome Sequence and Biofilm Production of a Carbapenemase-Producing Klebsiella pneumoniae (KpR405) Sequence Type 405 Strain Isolated in Italy. (PubMed, Antibiotics (Basel)) - "In recent years, the decreasing cost of next-generation sequencing and its easy use have led to it being considered a useful method, not only for outbreak surveillance but also for rapid identification and evaluation, in a single step, of virulence factors and resistance genes. Carbapenem-resistant strains of K. pneumoniae have become endemic in Italy, and in these strains the ability to form biofilms, communities of bacteria fixed in an extracellular matrix, can defend the pathogen from the host immune response as well as from antibiotics, improving its persistence in epithelial tissues and on medical device surfaces."

Journal • Infectious Disease • Pneumonia