In drug development, opportunism can play as important a part in the process as years of scientific endeavour.

Take Nuformix Plc (LON:NFX) and its NXP002 programme for idiopathic pulmonary fibrosis (IPF), an often-deadly lung condition.

Yes, it has come up with what looks like a potential breakthrough inhaled therapy for IPF; one that mitigates many of the side effects of existing and future oral treatments.

But without the delivery technology (in the form of the new wave of smaller more effective hand-held nebulisers) all that hard work may have been more challenging to exploit so rapidly.

That point is not lost on Dan Gooding, the chief executive of Nuformix.

A lot has changed 

“A lot has changed very recently with handheld nebulisers. We can now deliver a significant dose to the periphery of the lung where fibrosis is happening,” he explained.

Gooding points to two more recent innovations that could radically shorten the development timeline of NXP002 – a human lung tissue model that obviates the use of unreliable animal testing and new biomarkers for the IPF.

“We are benefiting from changes of understanding of the disease; changes in the measurement of disease progression allow us to reduce study periods by 75%,” said the Nuformix CEO.

“We’re 100% focused on delivering our fibrosis programmes because we have great data in human tissue, can get our drug to where it’s needed and can benefit from advances in studying disease progression quickly in the clinic.”

At this point, it is probably worth explaining that Gooding’s company represents a departure from the traditional small-cap drug development company that’s normally a binary bet on a university-discovered compound.

Instead, it takes small molecule (pharmaceutical) drugs that are already on the market and re-engineers their crystalline form using a platform called cocrystal technology.

In doing so, new options are created that might allow a change in the way a drug can be administered, or enable a re-purposing into a completely different disease; both aspects being the case with NXP002.

Major hurdle removed

Because known drugs have usually been approved previously and their underlying chemistry is not changing, safety issues have been addressed, removing a major hurdle in drug development.

That leaves Nuformix just to prove that the new application passes muster against existing standard of care treatments, which in IPF are well-known to lack efficacy and tolerability.

The Nuformix business model is to advance products to a clinical proof-of-concept phase before out-licensing, also opening up the potential for acquisition.

A recent report in a Sunday newspaper suggested that Nuformix was close to agreeing an out-licensing deal for the Asian rights to NXP002.

A subsequent market update confirmed it was in talks with several potential partners, with negotiations progressing.

Gooding was tight-lipped on the status of the process but agreed any deal would likely take the standard licensing agreement form.

In other words, it would be expected to consist of an upfront consideration, a contribution to development costs, milestone payments and a royalty on sales. 

Commercial deal would represent an inflexion point

A commercial breakthrough of this ilk would represent a major value inflexion point for the business.

In the meantime, Nuformix has raised a quickfire £1.25mln that will help fund the ongoing development of NXP002, alongside NXP004, which is described as a “new, breakthrough entry to the pipeline” with applications in cancer and fibrosis. It is also working to create patented cannabinoid cocrystals with a private Canadian firm called Ebers Tech.

On NPX001, its cancer care drug, Gooding admitted being “a bit let down” by Chinese partner Newsummit following a delay to payments owed to Nuformix.

“However, we are hoping to change that from a delay to a really positive story,” he added.

In the meantime, the focus is very firmly on NPX002, for which Gooding and his team harbour high hopes.

“The systemic safety data package exists, what doesn’t exist in a readily useable form are the data that show the drug is tolerable in the lung, but we know this has been generated elsewhere,” said Gooding.

NXP002 is being developed to treat IPF and IPF-induced cough, a side effect of the condition that affects over 80% of patients.

The inhaled treatment offers the prospect of reduced competition, increased efficacy and fewer side effects, said CEO Gooding.

Two current treatments 

The two current standard treatments are blockbusters but are highly unpleasant for patients to take and don’t greatly extend life, says Gooding.

NXP002 has already scored well against one of the standards, Esbriet, in advanced human IPF issue laboratory tests.

As an inhaled treatment there is the potential to use in combination with other oral therapies.

What really excites Gooding is that the mechanisms for the treatment of different forms of fibrosis are similar.

“We should have a really good shot at doing something really meaningful, both for patients and for Nuformix,” said Gooding.