Accelagen Fast Tracks First-in-Human Anti-BKV Therapy Trial

When Swiss biotech sponsor Memo Therapeutics sought to trial a promising novel treatment for BK virus (Human polyomavirus 1), they turned to Accelagen, a leading Australian Clinical Research Organisation (CRO). BK virus (or BKV) is a polyomavirus that many humans carry asymptomatically or with mild symptoms. BKV infection can have serious consequences in immunocompromised patients, particularly those undergoing kidney transplants. Reactivation of the virus can lead to complications that jeopardise transplant success, and it often persists throughout the life of the affected individual.

With no approved treatments available for BKV infection in immunocompromised patients, this was a therapeutic area in need of innovation. Memo Therapeutics engaged Accelagen to lead a Phase I clinical trial of its novel treatment in Australia, which has delivered beyond expectations.

For early stage biotech companies, Phase I can represent a pivotal moment where timelines, data quality, and operational execution may determine funding and development pathways. The sponsor required a partner capable of moving quickly without compromising regulatory rigour or scientific integrity, and Accelagen emerged as the ideal collaborator.

From the outset, Accelagen established a close working relationship with the sponsor and managed the full scope of project delivery. The initial ethics submission took place in late March, 2022 with approval granted just over a month later. This rapid turnaround is often a rare achievement in clinical research and allowed for swift recruitment and timely delivery of the clinical study report.

The quality of data prepared by Accelagen supported the sponsor in obtaining Fast Track designation from the FDA - a major milestone that recognises the therapy’s potential to address a serious, unmet medical need. In fact, just 32% of submitted novel treatments were granted a Fast Track designation in that same year. For a smaller biotech, this is not only a regulatory advantage but a strong signal to future investors and partners.

Following a successful Phase I, the sponsor progressed directly into a pivotal Phase II/III trial, which is currently recruiting. If successful, this therapy could reshape post-transplant care by helping prevent BKV-associated graft loss. Accelagen’s structure had a major role to play in the success of the trial, which balances tight coordination and the flexibility to respond in real-time while avoiding administrative delays.

As Project Manager Lily Alldrich explains,  “Everyone has a really broad range of skills… because we’re not an overly large company, it means we can be really agile.”

With impressive regulatory experience, Accelagen had the foresight to anticipate questions and concerns an ethics committee or the FDA might have raised. They were able to address these potential issues upfront, which eliminated the usual back-and-forth that delays many trials.

With in-house capabilities in medical writing, statistical analysis, data management, and regulatory process management, Accelagen is able to leverage the capabilities of a typically larger CRO but with the agility and white glove approach many in the industry envy. This removed the need for third-party vendors or other external approvals for different aspects of the project, and communication was straightforward and efficient.

Accelagen’s project management approach is integrated and collaborative, and regular meetings ensure everyone is kept accountable and invested. While Accelagen has grown in size since 2022, the core culture of partnership has persisted without diluting responsiveness or performance.

With biotech innovations, time can determine whether a therapy advances or fails. Clinical trial outcomes can be inflection points in the company’s growth, and the right CRO partner can make all the difference. Accelagen’s ability to deliver quickly and with high quality helped secure both regulatory progress and financial continuity for the sponsor.

Boutique doesn’t mean limited. For Accelagen, it means focused, strategic, and capable of delivering results that outperform expectations. In clinical research, clean data, smart planning, and proven experience are just as vital as the therapy itself. As Accelagen continues to grow, it remains committed to its agile spirit, strategic execution, and smart partnership model to enable sponsor success and bring important therapies to market.