- VIVIAD and VIVA-MIND studies both advancing as planned at 600mg twice daily following positive DSMB decisions; VIVIAD safety update with cut-off as of
November 20, 2023 , confirms low level of discontinuations - On track to report VIVIAD final topline Phase 2b data during end of Q1/2024
- Commenced preparations for VIVALONG, an open-label extension study
- Unveiling focused growth strategy leveraging varoglutamstat and VIVIAD and investing in QPCT/L small molecule platform
- Chief Financial Officer transition with promotion of
Anne Doering , CFA, effectiveMarch 1, 2024 - Management to host conference call today at
3:00 pm CET (9:00 am EST )
“In the third quarter of 2023, we continued to make significant progress with the clinical development of our core asset, varoglutamstat. From learnings across currently approved monoclonal antibodies, we see a clear unmet need among early Alzheimer’s disease patients for a safe and effective oral therapy and we believe that varoglutamstat can address this gap,” said
Q3 2023 and Post-Period Portfolio Highlights
Varoglutamstat Clinical Program:
Varoglutamstat is a differentiated investigational small-molecule medicine in development to treat Alzheimer’s disease (AD). It is currently being investigated in two large Phase 2 studies, VIVIAD (NCT04498650) in
Varoglutamstat is designed to prevent N3pE-Abeta formation, rather than aiming to clear existing plaques, making it an intervention upstream of other approaches such as monoclonal antibodies (mAbs). Through a second mode of action, varoglutamstat also modulates neuroinflammation via the CCL2 pathway, which, in turn, has an impact on tau pathology.
VIVIAD
VIVIAD (NCT04498650) is a state-of-the-art Phase 2b study being conducted in
- In
July 2023 , Vivoryon announced a safety update based on data from all 259 randomized patients which showed no clinical signs of varoglutamstat associated ARIAs at the cutoff date ofJune 14, 2023 . The independent Data Safety Monitoring Board (DSMB) decided the study should continue as planned and that no additional DSMB meeting will be required until study completion. - In
October 2023 , Vivoryon hosted a virtual R&D Event with Key Opinion Leaders (KOLs) focused on the clinical utility of primary and secondary endpoints of the VIVIAD study. The primary endpoint, which is a combination of three elements of the Cogstate neuropsychological test battery (NTB), called “Cogstate 3-item scale,” includes Identification, Detection and One Back tests and evaluates attention and working memory domains over 48-96 weeks. Key secondary efficacy endpoints include in hierarchical order: Cogstate Brief Battery (CBB, 4-item scale), the full Cogstate NTB (8-item scale), the Amsterdam Instrumental Activities of Daily Living Questionnaire (A-IADL-Q), and electroencephalogram (EEG). - In the VIVIAD study, discontinuation rates to date remain favorable (cut-off date of
November 20, 2023 ). The total number of discontinuations remains low in VIVIAD throughout the study at less than 13% based on blinded data. In addition, the number of discontinuations due to adverse events (AEs) has remained at less than 4%. - The statistical power of VIVIAD to detect a potential treatment difference of Cohen’s d of 0.35 between active and placebo is confirmed to be above 80% as assumed in the study protocol.
- Vivoryon remains on track to share final topline data during the end of the first quarter of 2024 and the full dataset at a subsequent medical meeting. Following the VIVIAD data readout, the Company expects to conduct an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the second half of 2024.
- The end of the active treatment phase in VIVIAD is estimated to occur by year end 2023, which is then followed by a minimum period of four weeks of safety follow-up visits with rigorous data and statistical analysis thereafter.
- Vivoryon expects the final VIVIAD dataset to include an evaluation of patients following the 12-week titration period, which is the same for every patient randomized to the active arm. The 600mg BID is applied in approximately 75% of the treatment weeks of all patients and the 300mg BID is applied in approximately 25% of the treatment weeks.
VIVA-MIND
VIVA-MIND (NCT03919162) is a complementary Phase 2 study for varoglutamstat being conducted in the
- In
October 2023 , Vivoryon announced that the study’s independent DSMB unanimously recommend that VIVA-MIND should proceed with a dose of 600mg BID through the remainder of Phase 2a and 2b. This decision follows theSeptember 2023 DSMB quarterly safety review of adverse events and labs, and theOctober 2023 analysis of treatment-emergent adverse events of special interest (AESI) pertaining to skin and subcutaneous tissue disorders and hepatobiliary disorders, as well as target occupancy and plasma pharmacokinetic (PK) data. - With VIVA-MIND, the Company has confirmed the feasibility of an up-titration protocol to the final dose of 600mg BID which is accelerated compared to the ongoing VIVIAD Phase 2b study. VIVA-MIND is continuing to recruit participants into the second cohort, with 21 sites open across the
U.S. - Vivoryon’s regulatory strategy for VIVA-MIND follows an adaptive trial design which includes the option to expand the study to a confirmatory Phase 3 study contingent on VIVIAD results and regulatory feedback.
VIVALONG
- In
July 2023 , Vivoryon announced that it commenced preparations for an open-label extension (OLE) study, VIVALONG, to provide a long-term treatment option to patients after completion of treatment under the VIVIAD or VIVA-MIND protocol. - The launch of VIVALONG is contingent on the outcome of VIVIAD.
- Pending VIVIAD results, Vivoryon plans to assess the long-term treatment of varoglutamstat including positron emission tomography (PET) imaging and other key safety and efficacy endpoints.
Early-Stage Pipeline and Kidney Disease Exploration:
- Vivoryon is unveiling additional opportunities in R&D activities stemming from its proprietary oral small molecule QPCT/L inhibitor platform. Following the VIVIAD readout, Vivoryon plans to leverage findings to further bolster its platform capabilities and potentially nominate new development projects in 2024.
- The Company has initiated the identification of novel oral QPCT/L inhibitors as second generation compounds in early AD.
- The VIVIAD study will now include additional biomarkers to investigate the effect of QPCT/L inhibition on kidney function.
- Activities to identify suitable new chemical entity (NCE) oral QPCT/L inhibitors as potential development projects in 2024 are underway in multiple disease areas including AD, chronic kidney disease, NASH, oncology and orphan CNS, such as Huntington’s disease and Down syndrome.
Corporate Development Updates:
- In
September 2023 , Vivoryon held an Extraordinary General Meeting (EGM) related to the appointment ofFrank Weber , MD, as CEO andAnne Doering , CFA, as Chief Strategy & Investor Relations Officer (CS&IRO). The shareholders approved all items on the agenda of the meeting, including the appointment ofDr. Weber andAnne Doering to the Company’s Board as executive directors. - The Company announced the appointment of
Anne Doering as Chief Financial Officer (CFO), leveraging Ms. Doering’s deep capital markets experience and enabling a smooth management transition as she succeedsFlorian Schmid onMarch 1, 2024 .
Financial Results for the Third Quarter of 2023
No revenues were generated in the nine months ended
Research and development expenses of
General and administrative expenses of
Net loss of
The Company held
Cash flows used in operating activities were
Cash flows used in investing activities were
Cash flows provided from financing activities were
Financial Guidance
Including the proceeds from the capital raise completed in
Conference Call and Webcast
Vivoryon will host a conference call and webcast today,
A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: https://register.vevent.com/register/BI44eb013feef24cb5818e6711539120de
It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance.
Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
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About
Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by our passion for ground-breaking science and innovation, we strive to change the lives of patients in need suffering from severe diseases. We leverage our in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. Beyond our lead program, varoglutamstat, which is in Phase 2 clinical development to treat Alzheimer’s disease, we have established a solid pipeline of orally available small molecule inhibitors for various indications including cancer, inflammatory diseases and fibrosis. www.vivoryon.com
Vivoryon Forward Looking Statements
This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of the
For more information, please contact:
Investor Contact
Stern IR
Tel: +1 212-362-1200
Email: janhavi.mohite@sternir.com
Media Contact
Tel: +49 175 8041816
Email: vivoryon@trophic.eu
Attachment
- 231206_VVY 3Q 2023
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