What You Need to Know About PrEP Biopharm

What You Need to Know About PreEP BioPharm
December 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff

PrEP Biopharm is a UK-based company that has a prophylactic drug in development for the cold and flu, a weekly nasal spray that “arms the innate immune system against cold- and flu-causing viruses.” A spinout of Johnson & Johnson , the company is headquartered in London.

The company’s lead product acts to stimulate the TLR3 and Mdi receptors in the nose, which causes a localized interferon response. It has also shown preclinical efficacy against MERS and SARS.

Ryan Muldoon, founder and chief executive officer, said the drug has a rapid, broad-spectrum prophylaxis against a range of viruses that cause upper respiratory infections. The company is optimistic about the compound, projecting that it will hit the market no later than 2020. “Ultimately, we feel we could expand this past the immunocompromised,” Muldoon told MedCityNews at the BIO International Convention “Ultimately, we think it’s safe enough to go over-the-counter (OTC)—that would be the long-term life cycle strategy.”

Company Leadership
Ryan Muldoon—founder and chief executive officer. Muldoon is also the senior director of New Business Development for Johnson & Johnson.

Kym Denny—director. Denny is also the chief executive officer of hVIVO.

Bruce Malcom—co-founder and chief scientific officer. Malcom is the co-inventor of PrEP-001.

Company Financing
On Nov. 2, 2015, PrEP Biopharm, announced that it had closed a $32.45 million Series A financing round. Lead investors were hVIVO, and Johnson & Johnson Innovation , as well as U.S.-based angel investors. The company indicated it will use the funds to complete its Phase IIa clinical trial.

The company’s drug in development is PREP-001. Not much has been disclosed about this lead compound except that it is a powder-based reformulation of an unnamed polyacene that’s been on the market for 40 years. It has apparently been used in some antiviral trials as a control. Proof-of-concept was demonstrated in a double-blind, placebo-controlled, challenge trial using human rhinovirus 16 (HRV16) in healthy volunteers. In that trial, the drug showed a three-fold decrease in clinical illnesses compared to placebo. It has completed Phase Ib and IIa clinical trials and is expected to expand its IIa and launch a IIb clinical trial. The Phase IIa is expected to be completed in 2016.

A proof-of-concept study was conducted by Janssen (a J&J company) using hVIVO’s platform in 2013?2014.

Market Competition
Besides every company that manufactures cold and sinus medicine, the primary preventative competitor is Genentech with its Tamiflu nasal flu preventative.

Dollars and Deals
As part of the Series A financing round, hVIVO acquired equity in the company for £14 million cash consideration. PrEP has also contracted with hVIVO Services to conduct a £10 million Phase II clinical trial in 2015 and 2016.

What to Look For
With Phase IIa and IIb clinical trials ongoing in 2016, expect more data on the drug’s efficacyefficacy—as well as more details about the compound itself. Expansion into asthma and other respiratory disorders besides cold and flu may also be in its future.

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