hVIVO (HVO) , a contract research organisation specialising in human challenge trials, has noted the success of a human challenge study conducted by hVIVO at its facilities in London.
Pneumagen, a clinical-stage biotech company, reported successful clinical proof of concept for its broad-spectrum antiviral candidate Neumifil, following a Phase 2a influenza human challenge study.
The study enrolled 104 healthy adult volunteers through the FluCamp platform, using a randomised, double-blind, placebo-controlled design. It assessed two Neumifil dose regimens, administered as an intranasal spray to participants who were subsequently infected with influenza virus.
Neumifil showed a clinically significant reduction in both the frequency of symptomatic influenza infection and the severity of symptoms, which was statistically significant when compared to the placebo. It was also tolerated with no new emergent adverse events or safety signals from the study compared to its first in human study.
Pneumagen now plans to advance Neumifil into further clinical studies, which includes the evaluation of Neumifil's ability to reduce the incidence of viral induced exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "We are delighted to see Pneumagen obtain these results clearly achieving clinical proof of concept for Neumifil, which has supported Pneumogen's decision to progress the candidate into further clinical studies, including in patients with COPD. This is another example of the value of human challenge trials in delivering clinical efficacy data and de-risking later clinical development."
View from Vox
Today’s news is further evidence of the value of human challenge studies. Such studies provide great value for biopharma as they offer access to fast and cost-effective data that enables easy decisions ahead of larger Phase 2 trials, giving companies the best chance of quickly advancing their candidates through the development pathway.
Strong demand for hVIVO’s human challenge trials is reflected in hVIVO’s rapidly growing orderbook, which clocked in at £78m in H1 2023, with the most recent £13.1m contract signed in July for the development of an Influenza B virus challenge model.
In H1 2023, hVIVO saw revenues increase 52% to £27.3m, compared to £18m in H1 2022. EBITDA more than doubled to £5.2m from £2.3m last year and EBITDA margin increased to 19.1% from 12.6% a year ago. Net cash also doubled to £31.3m as of June 30 2023, compared to £15.9m in June 2022. The company's weighted contracted orderbook stood at £78m on June 30 2023, from £70m a year ago.
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