Orph4 Aug 2021 09:51
Outlined within its quarterly report, Pfizer cited key data from the hVIVO-sponsored human challenge trial, which involved testing a vaccine candidate of respiratory syncytial virus (RSV).
Furthermore, results from the study yielded 100% efficacy against symptomatic disease in 18- to 50-year-olds.
(Source: Pfizer)
Results from Phase 2, which is to be submitted for peer-reviewed publication soon, show the vaccine was 100% effective against mild-to-moderate symptomatic infection. The Group highlighted that most participants in the study experienced minimal to no side effects.
Meanwhile, as a performance benchmark, the Ad26.RSV preF vaccine showed 52% observed efficacy in the same human challenge model, the company outlined to investors.
In Pfizer's 2Q21 earnings conference call which occurred last Wednesday, Mikael Dolsten, President of Worldwide Research and Development and Medical noted that there remains much excitement about the trial’s data as well as the opportunity for an RSV adult vaccine.
Addressing Pfizer shareholders, he commented: “There are hundreds of thousands of cases, and they -- per year in the US, and they are particular, of course, difficult for -- in older adults above 60 or adults that have underlying conditions, whether chronic lung diseases or immunocompromised. Now, there are actually up to 15,000 deaths just in the US annually.”
Going forward, Phase 3 of the human challenge study which will be focused on RSV in adults is expected to commence in 3Q21 with a potential conclusion expected as early as 1Q22.
View from VOX
hVIVO is proving to be a world class asset for ORPH.
In addition to being selected by Pfizer for RSV as outlined above, it was recently chosen to work alongside the UK Government earlier this year as part of the of the characterisation study where researchers would aim to identify a dose of the COVID-19 virus that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers. Last month, the UK Government said it had decided to expand the Human Challenge Programme to answer further questions that can help in the fight against COVID-19.
The study, which is being conducted by hVIVO at the Royal Free Hospital and funded by the UK Government who have commissioned Imperial College London as the study sponsor, will initiate as soon as appropriate regulatory approvals and clinical preparations are complete.
The Group said existing data from the characterisation study has already provided valuable insight into the biology of the virus which causes COVID-19 while further data is expected to improve the ability to manage the virus and deliver a range of treatment options in the future.?
Also commenting on ORPH’s outlook, analysts at research firm Arden Partners said the group’s pipeline is ‘continuing to grow through interactions with key global pharma players with signed deals in 2021 already ahead of 2020, underpinning confidence in the outlook.’?
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