DHP1401 / Dae Hwa - LARVOL DELTA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients with Mild to Moderate Alzheimer's Disease Treated with Donepezil: DHP1401 Randomized Trial in Mild to Moderate Alzheimer's Disease (DRAMA). (PubMed, J Alzheimers Dis) - "Although the effectiveness of DHP1401 was not proved to be superior as the primary efficacy endpoint, the secondary endpoints, MMSE and K-TMT-e type B, showed significant beneficial effects. Also, the subgroups showed that ADAS-cog scores significantly were improved. DHP1401 could be proven beneficial for the AD treatment by further clinical trials."

Clinical • Journal • P2b data • Alzheimer's Disease • CNS Disorders

[VIRTUAL] ALZHEIMER’S DRUG DEVELOPMENT PIPELINE: NOVEL TARGETS AND INNOVATIVE APPROACHES (AAT-ADPD 2020) - "Selected (non-exhaustive) examples of agents addressing these alternate pathways include: posiphen for presenilin processing; ALZ-801 and AAVrh.10hAPOE2 addressing ApoE-related biology; DHP1401, CT1812, LM11A-31-BHS, and AR1001 focus on synaptic function; levetiracetam, deferiprone, GV1001, and NDX-1017 for neuroprotection; COR388, niflamapimod (VX-745), and GV-971 for immunity and inflammation; AMX0035, AUS-131 and MP-101 for mitochondrial energetics; candesartan, telmisartan, and dabigatran for vascular factors; liraglutide, dapagliflozin, for metabolic dysfunction; MAPTRx/BIIB080 is an RNA-based intervention and vafidemstat and apabetalone are epigenetic interventions; and lupron, a hormonal intervention (gonadotropin-releasing hormone receptor agonist). One novel combination approach consists of losartan, amlodipine, atorvastatin and exercise and rasagiline is an example of molecule with pleiotropic effects on dopamine and disease-biology pathways...Novel designs..."

Alzheimer's Disease • CNS Disorders • APOE

Simultaneous determination of donepezil, 6-O-desmethyl donepezil and spinosin in beagle dog plasma using liquid chromatography‒tandem mass spectrometry and its application to a drug-drug interaction study. (PubMed, J Pharm Biomed Anal) - "This validated method was then successfully applied to a pharmacokinetic study in beagle dogs with no evidence for potential drug-drug interactions between DHP1401 and donepezil hydrochloride. This information and optimized assay can be useful for the anticipated co-administration of these two drugs in clinical settings."

Journal • Alzheimer's Disease • CNS Disorders

Dialogue constraints, 43 million investment by dementia clinical failure (thebell) - "Daehwa Pharmaceutical turned to plans for health food development. However, the company said that it will consider developing a drug for dementia patients by conducting a separate phase 3 clinical trial for mild patients...As Daesang Pharm has already covered the entire development cost of the dementia treatment DHP1401, there will be no impact on profit or loss from this clinical failure."

New P3 trial

Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA) (clinicaltrials.gov) - P2b; N=180; Completed; Sponsor: Daehwa Pharmaceutical Co., Ltd.; Trial completion date: Feb 2019 ➔ Aug 2019

Clinical • Trial completion date

Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA) (clinicaltrials.gov) - P2b; N=180; Completed; Sponsor: Daehwa Pharmaceutical Co., Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Jun 2019 ➔ Feb 2019

Clinical • Trial completion • Trial completion date