Nuformix’s NXP002 for IPF Shows Promise in Preclinical Studies

Marta Figueiredo, PhD avatar

by Marta Figueiredo, PhD |

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NXP002, Nuformix’s experimental inhaled therapy for idiopathic pulmonary fibrosis (IPF), achieves significant levels in the lungs and lowers the production of molecules that promote scarring, according to preclinical studies involving rats, the company announced.

“We’re delighted with the positive readout of this data so far and it further cements our belief in NXP002 as a valuable asset,” Anne Brindley, PhD, Nuformix’s CEO, said in a press release.

“We have previously reported data on the activity of NXP002 in human IPF lung slices [grown in the lab], and the [animal] results to date are consistent with these data,” Brindley added.

These positive findings support NXP002’s further development, and additional studies are now assessing the durability of the therapy’s effects, Brindley said, adding: “We look forward to updating the market in due course.”

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Nuformix is focused on repurposing medications approved for one health condition — and proven to be safe for human use — to treat scarring-related conditions and cancer, thereby cutting both the costs and time required to develop a safe and effective treatment.

The company uses cocrystal technology to modify the chemical structure of approved compounds without altering their therapeutic potential.

Nuformix’s lead therapy candidate, NXP002, is a new formulation of tranilast, an oral antiallergic medication shown to have anti-scarring effects.

Studies conducted by the U.K.-based company also showed that tranilast reduces lung tissue scarring, or fibrosis, by suppressing the production of extracellular matrix (ECM) proteins. When present in excessive levels, they contribute to IPF. The ECM is the network of proteins and other molecules that surrounds and supports cells in tissues.

“Tranilast is poorly soluble, meaning it is not well absorbed into the body and tissues, and it also has issues regarding systemic toxicity,” Brindley said, adding that NXP002 “shows greater solubility than the original [compound], allowing it to be delivered to the lungs that are the site of action for IPF.”

By delivering NXP002 directly into the lungs, the company anticipates that “a lower dose will be required to produce a pharmacological and therapeutic effect with reduced systemic toxicity compared to oral dosing,” Brindley said.

Previous studies in lab-grown lung tissue collected from IPF patients showed that NXP002 reduced fibrosis and inflammation and that these effects were increased when the therapy was combined with standard IPF treatments — Genentech’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib).

Newly announced data concern additional research focused on the feasibility of inhaled delivery and its effects in rats.

First, researchers found that NXP002 could be formulated into a simple and stable solution with properties suitable for inhaled delivery through nebulization, which creates a fine mist of the medication. The new formulation was also able to achieve the right particle size range for lung delivery using off-the-shelf and commonly used nebulizer devices.

These findings supported the feasibility of delivering NXP002 through nebulization, which was then tested in rats. In these animal studies, researchers evaluated the therapy’s pharmacokinetics (movement into, through, and out of the body) and pharmacodynamics (effects on the body) when delivered through nebulization.

Results showed that NXP002 made its way efficiently to the animals’ lungs, achieving significant levels of exposure in that organ while limiting exposure to the rest of the body compared with oral dosing. In addition, inhaled delivery of NXP002 resulted in a dose-dependent reduction in the levels of fibrosis-relevant mediators.

As part of NXP002’s preclinical data package, the company is now evaluating the durability of the therapy’s anti-fibrotic effects in these rats, with results expected by early 2022.

Earlier this year, Nuformix announced that it would be receiving a U.S. patent for NXP002 and its therapeutic use.

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