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Open Orphan one step closer to breakthrough universal flu vaccine as Phase 3 trials proceed (ORPH)

A new flu vaccine called FLU-v supported by a subsidiary of Open Orphan (LSE:ORPH) will move on to wide-scale clinical trials, the Irish pharma group announced on Tuesday.

The importance to medical science of a universal flu vaccine is hard to understate.

Scientists have been clamoring for such a drug for decades. The seasonal flu vaccine may save lives, one leading scholar at John Hopkins told LiveScience. Meanwhile, Dr Amesh Adalja, who was not involved in the study, explained: “Each flu season begins with a race to predicte the characteristics of burgeoning flu strains and develop vaccines that will prevent widespread infection. 

The process is lengthy, slow and expensive, said Dr Adalja, which means doses are often in short supply. Viruses can also mutate part-way through the flu season, rendering drugs ineffective.

FLU-v is so promising as a contender for a new universal flu vaccine because it targets parts of the virus which are common to multiple strains. This means they are less likely to mutate and so treatments are slated to be more effective. The manufacturing process for FLU-v is synthetic and can take place all year-round instead of using egg cultures, so supply is also more robust.

A Phase 2b field study of the FLU-v vaccine yielded positive results and will now proceed to Phase 3, Open Orphan said in a regulatory news update.

The results of the study were published in the prestigious peer-reviewed Annals of Internal Medicine journal.

How drug testing works

Before any new drug is deemed suitable for general sale, it has to go through a rigorous testing schedule. This process begins with a company selecting a promising compound for development, followed by pre-clinical testing. 

Phase I is the first study of the compound in humans, usually in healthy volunteers. Phase II is the proof of concept stage, when its efficacy and safety is proven. Phase III is the final testing stage. This is when the drug is introduced to large population groups. This phase, which Flu-V is moving on to now, generates extensive safety data and proves the maximum response produced by a new drug. 

When Phase III is complete, drug companies can file the data to regulatory bodies in the UK, Europe and US for licensing applications and then for sale.

What’s next

The drug was developed by Imutex Limited, a London-based biotech research company formed in 2016 as a joint venture between Open Orphan subsidiary hVIVO and the SEEK Group.

Imutex is now is scheduling meetings with the US pharmaceutical regulation overseer, the Food and Drug Administration, as well as with the European Medicines Agency.

Open Orphan CEO Trevor Phillips highlighted the significant advantages of FLU-v over the seasonal flu vaccine.

The composition of the FLU-v vaccine will remain the same year after year,” he said. “It will not be subject to a strict vaccination window as is the case with seasonal flu vaccines. Also, being a universal vaccine, it should provide protection against new strains of flu virus which the seasonal flu vaccine is not able to do.”

More detail

The randomised double-blind study of 175 healthy adults showed that injected doses of FLU-v created a greater immune response than a placebo. This was the first human trial to demonstrate that the potential vaccine could prevent flu infection by increasing the body’s production of antibodies. 

It represents a significant leap forward for Open Orphan and exciting times at the AIM-listed pharma group. 

Executive chairman Cathal Friel said:  “The market potential for a broad spectrum universal influenza vaccine is significant and has become increasingly important and valuable in recent weeks when governments around the world are finally waking up and realising that universal flu vaccines need to be commercialised.” 

While coronavirus is a cold and not a flu virus, the fact that an epidemic of this kind has spread to 70 countries since appearing in China in December 2019 is a stark reminder of the power of these medical issues to harm both the economy and human health at large. 

There must be a better way forward than reliance on the traditional annual flu vaccination process which has variable efficacy, offers little protection against emerging strains and is available in limited quantities,” Friel said.  

We now await publication of the positive results data from the NIAID FLU-v study (004) in a peer reviewed journal while still focusing on the Company’s strategy of achieving profitability in the near term and as we target the rapidly growing CRO pharmaceutical services sector.”

The additional investment or cost associated with commercialising FLU-v, will come from out-licencing the final stages including Phase III trials of FLU-v’s study, to major international pharmaceutical companies, in Europe, North America, and very importantly also in China. But we are increasingly excited about FLU-v potentially finally entering phase III clinical trials and now is one of the most opportune times to be doing that.”

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