VO659 / VICO Therap - LARVOL DELTA

A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: Vico Therapeutics B. V. | N=40 ➔ 65

Enrollment change • First-in-human • Ataxia • CNS Disorders • Huntington's Disease • Movement Disorders • ATXN3

Vico Therapeutics Announces Patient Dosing in Twice-Annual Regimen of VO659 in Phase 1/2 Trial in Huntington’s Disease, Spinocerebellar Ataxia Type 3 and Type 1 (PharmiWeb) - "To date, several participants have been dosed and VO659 has been safe and well-tolerated with no serious adverse events....In addition, Vico has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and plans to initiate U.S.-based clinical trials for VO659 later this year, further expanding its global development program."

IND • Trial status • Ataxia • CNS Disorders • Huntington's Disease

CHDI’s 21st Annual HD Therapeutics Conference Poster Presentation (PharmiWeb) - "Vico’s Chief Scientific Officer, Nicole Datson, PhD, will present new data this week in a poster at CHDI’s 21st Annual HD Therapeutics Conference on the distinctive mechanism of action of VO659 and its ability to inhibit multiple drivers of CAG repeat–mediated toxicity. Vico’s Chief Medical Officer, Scott Schobel, MD, will also present a Phase 1/2 clinical trial update of VO659."

P1/2 data • Ataxia • CNS Disorders • Huntington's Disease

A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD (clinicaltrials.gov) - P1/2 | N=68 | Recruiting | Sponsor: Vico Therapeutics B. V. | Trial completion date: Sep 2025 ➔ Oct 2028 | Trial primary completion date: Sep 2025 ➔ Apr 2028

Trial completion date • Trial primary completion date • Ataxia • Genetic Disorders • Huntington's Disease • Movement Disorders • ATXN3

A clinical update from a first-in- human, phase 1/2a trial of the CAG repeat-targeting ASO VO659 in patients with Spinocerebellar ataxia types 1 and 3 and Huntington’s disease (ICAR-Ataxia 2024) - No abstract available

Clinical • P1/2 data • Ataxia • Huntington's Disease • Movement Disorders

Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington’s Disease (PRNewswire) - P1/2 | N=65 | NCT05822908 | Sponsor: Vico Therapeutics B. V. | "The Phase 1/2a trial interim data presented at the EHDN meeting demonstrated: A mean reduction of 28% in CSF mutant huntingtin protein (mHTT) in treated HD participants at day 85 compared to baseline with an immediate effect observed after the first dose at day 29; No sustained increase or decrease in Nf-L protein in CSF across treated participants at day 85 compared to baseline; VO659 appears generally safe and well tolerated at the 40 mg dose level in treated HD patients through the available clinical follow-up period; VO659 has a long half-life, indicating the potential for infrequent dosing estimated at 1-2 times per year...The Phase 1/2a trial remains ongoing and Vico plans to meet with regulators later this year to discuss the optimal path forward for the VO659 program."

P1/2 data • Regulatory • CNS Disorders • Huntington's Disease

Seroba and Kurma Partners Announce Complementary Series B Funding for Vico Therapeutics totaling €65.8 million ($70.7 million) (Businesswire) - "Seroba...announced today the completion of the second closing part of Series B financing round of Vico Therapeutics...Seroba joined the consortium of investors leading the planned second closing of the Series B financing round of an additional €11.5 million ($12.4 million) with participation from Kurma Growth Opportunities Fund supporting Vico to continue to advance their lead clinical program and further develop a portfolio of novel antisense oligonucleotides."

Financing • Ataxia • CNS Disorders • Genetic Disorders • Huntington's Disease

Vico Therapeutics Announces $60 million (€54 million) Series B Financing to Advance VO659 Clinical-Stage Program for Rare Neurological Diseases and Expand Pipeline (PRNewswire) - "Vico Therapeutics B.V...today announced a $60 million (€54 million) Series B financing....The financing will support overall company operations including advancement of the ongoing Phase 1/2a multi-center, open-label basket trial of VO659 in patients living with spinocerebellar ataxia type 3 (SCA3) and type 1 (SCA1) and Huntington's disease (HD)."

Financing • Ataxia • CNS Disorders • Genetic Disorders • Huntington's Disease

A Safety and Pharmacokinetics Trial of VO659 in SCA1, SCA3 and HD (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: Vico Therapeutics B. V.

New P1/2 trial • Ataxia • Genetic Disorders • Huntington's Disease • Movement Disorders • ATXN3

Vico Therapeutics Announces First Patient Dosed in Phase 1/2a Clinical Trial of VO659 in Huntington's Disease and Spinocerebellar Ataxia Types 1 and 3 (PRNewswire) - "Vico Therapeutics...today announced that the first patient has been dosed in a Phase 1/2a clinical study evaluating VO659 for the treatment of Huntington's disease (HD), spinocerebellar ataxia type 1 (SCA1) and type 3 (SCA3). VO659 is an antisense oligonucleotide (ASO) investigational therapy designed to target the CAG repeat expansion that causes all nine known polyglutamine diseases including HD, SCA1 and SCA3. 'We are encouraged by the continued progress of our development program and very pleased to announce the first patient dosed in this Phase 1/2a study of VO659 in HD, SCA1 and SCA3.'"

Trial status • Ataxia • CNS Disorders • Huntington's Disease