PrEP – 001
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PrEP 001 (Panviral Prophylaxis)

PrEP-001 is a nasally administered, broad spectrum agent that leverages the innate immune system to prevent upper respiratory tract viral infections. It is the flagship product of PrEP Biopharm, in which hVIVO have acquired a significant equity stake in November 2015.

AdobeStock_48896091-elderly-lady-with-flu-1400x927The common cold and the more severe influenza have a significant impact on productivity and human performance, and specifically influenza can have a significantly debilitating impact on normal human functions. Most people are aware that there is currently no treatment nor vaccine for the common cold, but less are aware of the healthcare burden the virus causes: with more than 6 million emergency room visits for the common cold and 110 million physician visits annually and $40 billion in healthcare costs per year from non-influenza viral infections in the US alone.

The common cold and flu are part of a wider ‘Upper Respiratory Viral Infections’ (URVIs) category with serious unmet medical need causing more than 500 million infections per annum, $125 billion healthcare costs) and creating undue burden for those patients with underlying respiratory disorders (i.e. chronic obstructive pulmonary disease, asthma, etc):

·       9.3 million exacerbations

·       850,000 hospitalisations

·      75% of the almost 62,000 deaths each year due to exacerbations

Description

RSV_howwedoit-1400x930PrEP-001 is a prophylactic compound focussed on the common cold (human rhinovirus) and flu (influenza).  It is a nasally administered, broad spectrum agent that leverages the innate immune system to prevent upper respiratory tract viral infections (colds and flus). This novel prophylactic nose spray delivers a benign surrogate for a respiratory virus into the nose which tricks the nasal lining cells into thinking they are being invaded by a real virus, which in turn activates the local innate immune defence system.

Stage of development

In a 2014 study conducted within the hVIVO platform, PrEP-001 secured its first proof of concept (POC) as a prophylaxis against the common cold by showing a threefold reduction in clinical illness and an eightfold reduction in common cold symptoms compared to placebo.

The questions below form the raison d’être behind the three PrEP-001 clinical studies we have been conducting during 2015 and 2016 to date:

• Does PrEP-001 also work in flu as well as the common cold?

• How long does the drug’s effect last?

• Does it prevent colds in asthmatics, thereby reducing their chances of asthma exacerbation?

It seems obvious that one would want to answer these questions early in product development, but the nature of the patient populations and the lack of understanding of our body’s response to viruses makes the development pathway complex and costly, and such questions historically could only be answered in large field based studies. By answering these questions in the hVIVO platform, the eventual field work can be fine-tuned, reducing the risk of aiming at the wrong patient population or indication in expensive field studies.

In typical hVIVO fast-paced fashion, hVIVO produced positive flu results from the 63 subject Phase IIa study within six months of the first subject visit.  Patients who received PrEP-001 showed a two-fold reduction in the AUC of the Total Symptom Score (TSS) (the primary endpoint), a two-fold reduction in the mean TSS, and a two and a half-fold reduction in clinical illnesses for flu when compared to placebo. In both the cold and flu POC studies, PrEP-001 reduced the number of infections as well as symptom severity and duration for those who become infected and the adverse events were similar to placebo.

PrEP-001 is anticipated to be a first-to-market prophylactic nasal spray that creates a novel paradigm of prevention against these URVIs.  Two additional Phase II studies to answer key questions around PrEP-001’s performance in asthma patients and dose duration in healthy subjects are underway.

Key milestones

In 2016, the PrEP Phase II program is currently underway with studies being conducted by hVIVO. You can read more about key milestone achievements in our PrEP related news releases:

·      “hVIVO invests in PrEP Biopharm Limited to further develop new prophylactic treatment for respiratory infections” 02 Nov 2015 – news release here

·      “hVIVO announces initial results for PrEP Biopharm’s PrEP-001 look favourable in Phase IIa influenza prophylaxis study” 25 April 2016 – news release here

·      “hVIVO confirms favourable results for PrEP Biopharm’s PrEP-001 Phase IIa influenza prophylaxis study.” 15 June 2016 – news release here

PrEP Biopharm Limited

PrEP BioPharm is a development stage biopharmaceutical company that is creating a fundamentally new paradigm of prophylaxis for upper respiratory tract infections.

In November 2015, hVIVO acquired a significant equity stake in PrEP Biopharm Limited (“PrEP Biopharm”) a new UK biotech company with its prophylactic compound PrEP-001, a compound where hVIVO’s platform has been a fundamental contributor to its success to date. This allows hVIVO to participate in the upside value generated by the product insights our platform provides. We are leveraging the platform’s speed of conduct for early phase research and application of its biological insights to simplify later phase studies – further enhancing PrEP-001’s potential going forward.

In 2014, hVIVO conducted a proof of concept study for Janssen using the hVIVO platform. This study demonstrated that Janssen’s compound (now renamed PrEP-001) achieved a threefold reduction in clinical illness and an eightfold reduction in common cold symptoms compared with a placebo. With these promising results, hVIVO saw tremendous commercial potential for PrEP-001.

Working with the other main PrEP Biopharm investors, which include Johnson & Johnson Innovation-JJDC Inc and the founders of PrEP Biopharm, we executed the PrEP Biopharm transaction completing it on 1 November 2015. From summer 2015, hVIVO commenced the complex clinical trial start up activities in order to target positioning of PrEP-001 for field Phase IIb.

Find out more about PrEP Biopharm Ltd. at http://www.prepbiopharm.com/.

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