New Saniona Treatment for IPF Ready for Phase 1 Clinical Testing

Preclinical data for SAN903 therapy 'very compelling,' company says

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by Steve Bryson, PhD |

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Following the successful completion of preclinical studies, Saniona is now ready to initiate the regulatory process needed to start testing SAN903 — its therapy candidate for idiopathic pulmonary fibrosis (IPF) and other disorders — in Phase 1 human trials.

“Preclinical data for SAN903 are very compelling,” Thomas Feldthus, Saniona’s CEO, said in a press release.

Palle Christophersen, the company’s executive vice president of research called SAN903 “the result of a long and challenging drug discovery phase.”

“I am incredibly happy that SAN903 … has now successfully completed the preclinical development package and is ready for entering the clinical stages,” Christophersen said.

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A new treatment for IPF

The potential first-in-class medication, to be developed by Saniona alone or with a partner, may provide a new treatment strategy for various diseases marked by inflammation and tissue scarring (fibrosis). These include IPF, but also inflammatory bowel disease (IBD) and chronic kidney disease (CKD).

“There is a significant unmet medical need and commercial opportunities in inflammatory bowel disease and rare fibrotic disorders,” Feldthus said.

IPF is a disease marked by fibrosis and inflammation in the lungs, which make it harder for patients to breathe. The condition is progressive, meaning that symptoms gradually worsen with time.

As part of a new treatment approach, SAN903 is designed to block KCa3.1, a calcium-activated potassium ion channel found on immune cells. KCa3.1 plays a role in regulating pathways that maintain inflammation in chronic diseases.

It also is found on connective tissue cells called fibroblasts, particularly those that are activated, where it supports the overproduction of connective tissue that leads to fibrosis.

SAN903 suppresses inflammation and fibrosis by preventing cell division and migration of activated immune cells and fibroblasts. The therapy dampens the release of pro-inflammatory immune signaling proteins, as well as collagen, the most common connective tissue protein tied with tissue scarring.

In a preclinical study, SAN903 significantly reduced markers of inflammation and fibrosis in a mouse model of induced pulmonary fibrosis. It also outperformed the approved anti-fibrotic medicine Esbriet (pirfenidone) in its ability to lessen tissue scarring.

Saniona said these results show the medication’s promise as a new treatment for IPF and other diseases marked by inflammation.

“We believe [SAN903] has potential to become first-line treatment in patients suffering from inflammatory bowel disease, IBD, where it could be the first maintenance drug with independent actions on both acute inflammation and chronic fibrotic complications,” Feldthus said.

“Other potential indications include fibrotic disorders such as chronic kidney disease, CKD, and the fatal lung disease idiopathic pulmonary fibrosis, IPF,” Feldthus said.