# hVIVO reports positive results from RSV antiviral human challenge trial

- Link: https://www.directorstalkinterviews.com/hvivo-reports-positive-results-from-rsv-antiviral-human-challenge-trial/4121173952
- Published: 2024-10-07T07:19:16+01:00
- Author: Amilia Stone

**[hVIVO plc](https://www.directorstalkinterviews.com/company/hvivo-plc/hvo.l)**(
[LON:HVO](https://www.directorstalkinterviews.com/company/hvivo-plc/hvo.l)), a fast-
growing specialist contract research organisation (CRO) and world leader in testing
infectious and respiratory disease products using human challenge clinical trials,
has noted the announcement by Enanta Pharmaceuticals, reporting positive topline
results from a Phase 2a Respiratory Syncytial Virus (RSV) human challenge trial 
in healthy adults conducted by hVIVO for EDP-323, its second RSV antiviral candidate.

EDP-323, a novel, oral, direct-acting antiviral in development for RSV infection,
has made impressive strides, achieving U.S. Food and Drug Administration (FDA) Fast
Track designation. The topline results from the HCT involving 142 healthy adult 
volunteers demonstrate the effectiveness of EDP-323. With participants split into
three cohorts (47 receiving a high dose, 47 receiving a low dose and 47 receiving
a placebo), the study showed that EDP-323 was generally safe, well-tolerated, and
demonstrated a rapid and sustained antiviral effect. The results show an 85-87% 
reduction in viral load area under the curve (AUC) by qRT-PCR (p<0.0001), a 97-98%
reduction in infectious viral load AUC by viral culture (p<0.0001), and a 66-78%
reduction of total clinical symptoms score AUC (p<0.0001) compared to placebo.

These positive results highlight the significant role human challenge trials play
in accelerating efficacy data collection and reducing the risks associated with 
later stage clinical development. With three decades of experience and expertise
in safely conducting human challenge studies, hVIVO is proud to support groundbreaking
research like this across a range of respiratory viruses, including RSV, influenza,
human rhinovirus (HRV – common cold virus), and COVID-19. The Company looks forward
to seeing continued success for Enanta and EDP-323 in the future.

Enanta’s full announcement is available here:

[Enanta Pharmaceuticals Announces Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected With Respiratory Syncytial Virus (RSV)](https://www.directorstalkinterviews.com/wp-content/uploads/2024/10/Enanta-Pharmaceuticals-Announces-Positive-Topline-Results-for-EDP-323-in-a-Phase-2a-Human-Challenge-Study-of-Healthy-Adults-Infected-With-Respiratory-Syncytial-Virus-RSV.pdf)
[Download](https://www.directorstalkinterviews.com/wp-content/uploads/2024/10/Enanta-Pharmaceuticals-Announces-Positive-Topline-Results-for-EDP-323-in-a-Phase-2a-Human-Challenge-Study-of-Healthy-Adults-Infected-With-Respiratory-Syncytial-Virus-RSV.pdf)

EDP-323 is Enanta’s second RSV candidate. Zelicapavir (EDP-938), Enanta’s first 
candidate, has already shown impressive results in an earlier RSV HCT and is in 
later stage clinical development.

> **Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:** _“Enanta’s trial
> demonstrates the depth of actionable insights a comprehensive human challenge 
> trial can provide. We congratulate Enanta on these impressive results, which mark
> a significant step forward in the development of new medicines to treat respiratory
> infections such as RSV. Achieving such positive outcomes underscores the potential
> of this novel RSV treatment to make a meaningful impact on patient care. We are
> proud to provide world leading human challenge trials to support the development
> of exciting drug candidates which hold the potential to have a positive impact
> on global health.”_

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