RE: Research notes1 Aug 2021 21:33
licensing agreement with AstraZeneca worth a headline US$377mln and upfront milestone; and another preclinical licensing agreement with Abbvie and Morphic Therapeutics was also done with an undisclosed headline value, again with upfront milestones.
In NXP002, Nuformix has eschewed traditional drug development by creating a new form of the original drug, tranilast, which has a long history of safe use as an oral drug for allergies in Asia but with evidence that supports its potential in fibrosis, including IPF.
Nuformix has generated its own IP, repurposing an existing drug and giving it a potential new lease of life with significant commercial potential.
NXP002 is differentiated because it's a new form of tranilast and it will be formulated for delivery direct to the lungs by inhalation, a new route of administration for this drug.
There are two reasons why this change in route of administration is important.
The first is practical as it provides a targeted treatment with hopefully fewer side-effects.
The second is that by discovering novel forms of tranilast, Nuformix is able to generate IP and get patent protection from generics.
IPF itself is an area of high unmet medical need and an ‘orphan’ disease. It’s a severe and progressive disease that affects the lungs, where dust, smoke, gastric reflux acid, genetic predisposition or infection leads to scarring known as fibrosis.
The prognosis is as bleak as some aggressive forms of cancer with an average survival time of three to five years.
While there are treatments, they tend only to be partially effective and have significant side-effects that cause some patients to stop treatment.
Because of the rarity of the disease, any new drugs that show signs of potential efficacy are likely to receive orphan drug designation.
This regulatory classification expedites the clinical trial process, reduces costs and extends the exclusivity period of the end product.
Taking the re-purposing route with Tranilast, rather than developing and testing a totally new molecule, compound or cell therapy, may also help shorten the timeline to market.
For example, a lot is already known about the safety and the way a drug such as Tranilast interacts with the body.
So, in this regard, there is also a greater probability of success, while the development costs are likely also to be lower than they would be with an unknown new therapy.
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