Therapy Areas: Vaccines
Virometix Announces Initiation of Phase 1 Clinical Trial with Its V-306 Vaccine Candidate
12 March 2020 - - Belgian health authority, FAMHP, has approved Switzerland-based biotechnology company Virometix's clinical trial application for the first-in-human phase 1 study of its respiratory syncytial virus vaccine candidate, V-306 in healthy volunteers, the company said.

Funding has been secured and activities are underway to initiate the trial in the coming weeks.

RSV is a seasonal virus infection and the most common cause of serious acute lower respiratory infection.

Infants and young children, as well as the elderly and immunocompromised are particularly at risk. No vaccine has been approved for the prevention of RSV infection.

The market opportunity for RSV is estimated to reach USD 5.4bn by 2028.

The phase 1 clinical trial will be a prospective double-blind randomised placebo-controlled study.

A total of 60 healthy female subjects of child-bearing age will be included.

V-306 or placebo will be administered by intra-muscular injection as an initial dose, followed by a boost dose 56 days later.

Subjects will be split into 3 equally sized dose cohorts, with each cohort receiving an increased dose of V-306 or placebo.

An independent data safety monitoring board will supervise the trial and approve enrolment of subjects into the next dose cohort after review of safety data.

The primary objective of the study will be to establish the safety profile of V-306 and secondary objectives will include an evaluation of the immunogenicity of V-306. Subjects will be followed for one year after the initial dose of V-306.

Virometix AG is a privately held Swiss biotechnology company developing a new generation of vaccines and immunotherapeutic drugs for the prevention and treatment of infections and cancer.

In an increasingly global world, there is a considerable medical need for vaccines to combat infectious as well as a number of chronic human diseases, including cancer.

Rational molecular design, chemical synthesis and Virometix' proprietary "Synthetic Virus-Like Particle" platform technology allow for the rapid production and optimization of vaccine candidates with the potential to demonstrate superior properties in terms of safety, efficacy and stability.
Login
Username:

Password: