Vivoryon Therapeutics AG: Vivoryon Receives IND Approval for Varoglutamstat's (PQ912) Phase 2 Study in Alzheimer's Disease
DGAP-News: Vivoryon Therapeutics AG
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Vivoryon Receives IND Approval for Varoglutamstat's (PQ912) Phase 2 Study in Alzheimer's Disease
HALLE (SAALE) / Munich, Germany, 04 August 2020 - Vivoryon Therapeutics AG (Euronext Amsterdam: VVY, ISIN DE0007921835) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for varoglutamstat (PQ912). FDA clearance of the IND will enable Vivoryon to initiate its U.S. Phase 2 clinical trial program for varoglutamstat (PQ912) in Alzheimer's disease as planned. All preparations at Vivoryon and its cooperation partner the Alzheimer's Disease Corporate Study (ADCS) at the University of California, San Diego, are in line with the project plan which aims for a study start around mid-2021 and a final data readout in 2023. The trial design will allow a seamless progression into Phase 2b.
The Phase 2a clinical trial will include 180 patients with mild Alzheimer's disease who will either receive varoglutamstat (PQ912) or a placebo orally over the course of six months. The trial design includes a drug-titration phase and a composite Neuropsychological Test Battery (NTB) score for assessing cognitive efficacy. Data on electroencephalography (EEG) and cerebrospinal fluid (CSF) biomarkers will be complementary to the already active Phase 2b EU trial, VIVIAD.
"The IND clearance represents the completion of the next milestone on our way to soon having two active Phase 2 studies assessing the efficacy of varoglutamstat. This step transforms our lead candidate into a frontrunner of novel therapeutic approaches beyond standard Abeta and Tau targeting drugs in development," commented Dr. Michael Schaeffer, Chief Business Officer of Vivoryon Therapeutics. "Varoglutamstat has already shown initial signs of cognitive efficacy in a three months Phase 2a trial in Europe, therefore, we are look forward to reviewing the efficacy results from both Phase 2 trials in Europe and the U.S.," he added.
Varoglutamstat (PQ912) is a novel drug candidate with disease-modifying potential for AD. The small molecule compound targets glutaminyl cyclase (QC), an enzyme which catalyzes the conversion of Abeta into pyroglutamate-Abeta (pGlu-Abeta). This highly toxic modification triggers the formation of toxic soluble Abeta oligomers, key culprits in AD pathology. The Vivoryon team was the first to discover and describe the relevance of the QC enzyme in human diseases in detail and has developed a broad intellectual property portfolio around QC inhibitors and assays.
04.08.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
|Company:||Vivoryon Therapeutics AG|
|Phone:||+49 (0)345 555 9900|
|Fax:||+49 (0)345 555 9901|
|Listed:||Regulated Unofficial Market in Berlin, Frankfurt, Munich, Stuttgart; Amsterdam|
|EQS News ID:||1108457|
|End of News||DGAP News Service|