US Patent Awaited for Nuformix’s Potential IPF Inhalation Therapy

Nuformix announced it has received notice that it can expect to be granted a U.S. patent for its potential inhaled therapy for idiopathic pulmonary fibrosis (IPF).

NXP002, the company’s lead pre-clinical asset, is a new formulation of tranilast, an antiallergic medication that is under investigation for its potential to inhibit lung tissue scarring, or fibrosis.

The patent application (No. 17/051,592) titled, “Crystalline tranilast salts and their pharmaceutical use,” covers the composition of a new crystalline form of tranilast and its potential use as a therapy. The allowance notice indicates that the U. S. Patent and Trademark Office (USPTO) recognizes that all requirements have been met and is a positive step toward the patent’s approval.

“I am very pleased that we have received this Notice of Allowance from the U.S. Patent Office meaning that this patent will proceed to be issued,” Anne Brindley, CEO of Nuformix, said in a press release.

“This is an important endorsement of Nuformix’s discoveries and also strengthens the patent estate for our lead asset NXP002. The US is the largest market for IPF (over 60% of the global market) and thus this is a key step forward for the Company and this asset,” Brindley added.

Nuformix uses cocrystal technology to modify the chemical structure of approved compounds without altering their therapeutic potential. The company aims to develop improved forms of “old” medications already proven to be safe for use. This approach allows Nuformix to limit development costs and shorten their timelines.

Studies conducted by Nuformix have shown that that tranilast inhibits lung tissue scarring by suppressing the production of proteins making up the extracellular matrix — the network of proteins and other molecules that surrounds and supports cells in tissues. Of note, the accumulation of components in the matrix is a hallmark feature of fibrosis and IPF.

The company’s new form of tranilast, NXP002, was developed to be inhaled and delivered directly to the lungs, a route that is considered more efficient and safe for the treatment of lung diseases.

Using fibrotic lung tissue collected from patients who had undergone lung transplants, researchers demonstrated that NXP002 candidates had inhibitory activity against fibrosis and acted on key inflammatory targets.

More recently, the U.K.-based company reported the beneficial effects of combining NXP002 with Genentech’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib), two approved antifibrotic IPF therapies. Tests of the combinations were done in lung tissue donated by an IPF patient.

According to Nuformix, further preclinical studies testing NXP002 is underway through outsourced expert contract organizations.

The company has filed two patent applications on new forms of tranilast. One has been awarded globally. The second patent application has now been allowed in the U.S., and has also been approved for what is known as the “patent prosecution highway,” which could accelerate its examination in other countries.