While not quite a cure for the common cold, Johnson & Johnson spinout PrEP Biopharm certainly intends to transform the cold and flu market with its prophylactic drug.
The startup’s developing a weekly nasal spray that arms the innate immune system against cold- and flu-causing viruses – and is raising $25 million to do so.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The startup just formed about three months ago, as a spinout of Johnson & Johnson – and aims to now raise a $25 million Series A. It presented at the Startup Stadium at this week’s BIO International Convention in Philadelphia.
“We’ll be the first to market in a new market – the prophylaxis of upper respiratory infections,” founder and CEO Ryan Muldoon told the audience. PrEP Biopharm is prepping for a blockbuster, he said.
The startup is keeping mum about the identity of its lead compound, PREP-001 – just that it’s a powder-based reformulation of an unnamed polyacene that’s been on the market 40 years, used in several antiviral trials as a control.
It’s not meant to work as a Tamiflu, that reduces the duration and virulence of flu symptoms. Rather, it’s meant to activate the innate immune – tickling your TLR3 and MDI receptors in the nose, and causing a localized interferon response.
The drug’s meant to prevent the most common form of cold and flu transmission – when folks touch infected surfaces, then graze their nose.
Muldoon described the drug as a rapid, broad-spectrum prophylaxis against a range of viruses that cause upper respiratory infections. On top of testing with the common cold, it’s also shown efficacy in preclinical work against MERS and SARS, Muldoon said.
It’s wrapped up Phase 1b and 2a trials, and is both looking to expand its 2a and launch a 2b clinical trial. Early human trials have shown a threefold decrease in clinical illness, Muldoon said, despite the fact that everyone in the study was infected with rhinovirus — a common cold. It showed an eightfold reduction in total symptoms, he said, and a four-day reduction in overall duration of the illness.
Though it hasn’t yet begun serious regulatory talks, Muldoon projects the expanded Phase 2a will be complete in 2016.
The only notable side adverse events were nosebleeds, stemming from patients stuffing the delivery device up their nose. Muldoon projects the drug — given its mild side effect profile and its demonstrated use on the market for 40 years – to be no later than 2020.
PrEP will roll out the drug first to a high-risk patient subset — the elderly, and folks with COPD and asthma, since upper respiratory tract infections most often lead to hospitalization among these patients. But he touts potential revenues that exceed $1 billion — with an eventual possibility to become an over-the-counter drug.
“Ultimately, we feel we could expand this past the immunocompromised,” Muldoon said. “Ultimately, we think it’s safe enough to go OTC — that would be the longterm life cycle strategy.”
