Company Background:
ReveraGen BioPharma Inc., a clinical-stage drug development company based in the US, specializing in rare diseases such as Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD), sought a CRO partner to support two Australian sites participating in vamorolone phase 2a studies (VBP15-002, VBP15-003) in DMD. After an extensive due diligence, ReveraGen selected Novotech. The CRO was once again selected for its Phase 2b study (VBP15-004) based on its consistent performance and positive experience.
Challenge:
ReveraGen faced the complex task of conducting its Phase 2b study, targeting FDA approval for vamorolone as a DMD treatment. The study, spanning multiple countries, and 32 sites, aimed to evaluate vamorolone's efficacy against a placebo and assess the safety and tolerability of varying daily doses. The global COVID-19 pandemic further compounded the challenge of executing the clinical trial effectively.
Action:
In response to these challenges, ReveraGen engaged Novotech's CRO services. This partnership began with the initiation of the vamorolone phase 2a studies in 2017, focusing on two Australian sites, and extended to a Phase 2b study at 32 sites.
Results:
Despite significant challenges posed by COVID-19, the clinical trial was executed successfully, enrolling 121 randomized patients across 11 countries (USA, Canada, Australia, Israel, UK, Sweden, Czech Republic, Belgium, Netherlands, Spain, Greece) and 32 sites. The study began in June 2018 with the enrollment of the first patient and concluded in August 2021 with the completion of the last patient.
ReveraGen has established a longstanding partnership with Novotech. The Company has expressed satisfaction with its services, consistent delivery on its contractual obligations and an overall positive experience dating back to its initial collaboration in 2017. The decision to extend the partnership for its Phase 2b study significantly contributed to the success of the vamorolone clinical program. The Company looks forward to partnering on future collaborations, highlighting the value of Novotech's expertise in advancing clinical research for new therapies and treatments.
Testimonial:
“We began working with Novotech in 2017 as we needed support for the two Australian sites taking part in the phase 2a studies in DMD. Based on our very positive experience with Novotech on these two studies, we decided to contract with them for our pivotal Phase 2b study as we required continued support for the Australian sites enrolling into this study. We were extremely comfortable with this decision as Novotech had always delivered in every aspect of their contracted responsibilities. Their contribution was vital for the success of the vamorolone clinical program”. Jesse Damsker, PhD Chief Operating Officer