The in-human study is scheduled for the first quarter of 2022 and will be conducted at subsidiary hVIVO’s state-of-the-art facilities in London.
The company expects the revenue from the contract to be recognised across 2021 and 2022 and form part of the huge jump in income expected this year and next as demand for challenge trials soars.
“Post-pandemic, the infectious and respiratory disease market is seeing exponential growth, with an expected global market value of US$250bn by 2025,” the company said in a statement with its half-year results today.
“This is resulting in a vastly increased market for Open Orphan to test a new range of infectious and respiratory disease products as the world leader in the provision of human challenge studies.”
Underlying profits [EBITDA] in the six months to end-June were GBP2.1mln, compared to a loss of GBP4.1mln a year earlier, while revenues soared to GBP21.9mln from GBP6.4mln.
That increase reflected six active challenge studies in the first half compared to just two a year ago and a solid performance in early clinical/biometry services, according to the statement.
Non-Covid related work accounted for 75% of revenues while since the half-year the company has won an GBP8.1mln asthma study (August 2021), significant hRV & Influenza study (July 2021) plus the flu contract announced today.
For the full year, Open Orphan expects revenue of GBP40mln with non-Covid work expected to represent around 70% of this.
Even with the jump, this will be slightly behind forecasts, it added, as some Covid studies will now likely start later than expected and commence in 2022.
For 2022, revenue is forecast to rise to GBP50mln though this will again depend on contract timing.
On the flu trial, Open Orphan added that the customer’s antiviral product had demonstrated effectiveness in animal preclinical models and has several clinical and commercial advantages over similar products.
Flu is expected to become a major problem again after being subdued by the measures taken to restrict the spread of Covid.
Cathal Friel, Open Orphan’s executive chairman, said: “As a result of social distancing, hand washing and other COVID-19 mitigation measures, there has been extremely low levels of population immunity to Influenza.
“As such, there is an increasing concern that in the year ahead influenza outbreaks could spike considerably and therefore this type of therapeutic could form part of an effective defence against future outbreaks of Influenza due to its compelling array of clinical and commercial advantages.”
Open Orphan has challenge trial models in a range of infectious and respiratory disease markets, including RSV, Influenza, Asthma, hRV, COPD and Malaria.