Potential IPF add-on NXP002 reduces fibrosis markers: Early tests

Nuformix plans testing in lung tissue samples from patients, healthy volunteers

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Treatment with Nuformix’s experimental therapy NXP002 reduced markers of fibrosis, or tissue scarring, in a laboratory model of idiopathic pulmonary fibrosis (IPF), according to new data announced by the company.

Adding NXP002 to standard-of-care IPF treatments — Esbriet (pirfenidone) and Ofev (nintedanib) — led to a “clear, pronounced additive benefit,” data suggest.

“The results … are as good as we could have hoped for and are the first results from what is the most advanced iteration of this ‘close to patient’ IPF disease model to date,” Dan Gooding MD, PhD, Nuformix’s executive director, said in a company press release.

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NXP002 is inhaled formulation of anti-allergic medication

NXP002 is an inhaled formulation of tranilast, a molecule with anti-inflammatory and anti-fibrotic properties that has been used in the treatment of allergies. By delivering the molecule directly into the lungs, NXP002 is expected to minimize side effects and toxicities that can occur when tranilast is taken orally, as it usually is for allergy treatment.

Prior preclinical work with an older formulation of NXP002 suggested the therapy was able to reduce the production of pro-fibrotic molecules, but inconsistent data from animal studies caused a delay in moving the therapy to clinical testing.

Following the inconsistent results, Nuformix reformulated NXP002 and conducted a new set of preclinical tests, carried out in partnership with Fibrofind.

New studies were carried out in a 3D ex vivo human lung tissue model that researchers implemented by collecting lung tissue from patients and then taking it to a laboratory for testing. The model has recently been optimized to allow for less result variability.

“The reduced variability in the resulting data allows us to have high confidence in both NXP002’s anti-fibrotic activity alone, but also in the added anti-fibrotic performance it can deliver on top of existing standards of care,” Gooding said.

Nuformix reported that treatment with NXP002 alone led to “a strong, consistent anti-fibrotic effect,” as demonstrated by changes in the levels of multiple fibrosis markers. Adding both high and low doses of NXP002 to standard-of-care led to a further reduction in fibrosis.

In particular, co-treatment with a high-dose of NXP002 and standard-of-care nearly eliminated the release of pro-fibrotic markers. These data indicate that NXP002 may provide benefits for patients who are already on other IPF treatments.

The results … are as good as we could have hoped for and are the first results from what is the most advanced iteration of this ‘close to patient’ IPF disease model to date.

NXP002 showed no signs of toxicity in lab model

“Additivity to standard of care is the most important aspect because it’s the simplest option to investigate in a clinical study and is therefore fast becoming a top priority for potential licensing partners,” Gooding said.

NXP002 also showed no signs of toxicity in this model, according to Nuformix.

The company is now planning to further analyze data from these experiments to understand how NXP002 treatment impacted markers of inflammation, with plans to conduct additional experiments in lung tissue samples from more IPF patients and healthy volunteers.

“Having seen the quality of these results, our aim now is to generate datasets from three donors in both human IPF and healthy lung duration of action studies,” Gooding said. “These data can be generated quickly and will be essential in opening up new discussions with potential licensing partners and support overall progression of the NXP002 program.”