MDI Therapeutics has dosed the first participants in a Phase I study to support the development of a potential treatment for systemic sclerosis (SSc) and interstitial lung disease (ILD).

The primary endpoint of the Phase I study is to assess the overall safety and tolerability of MDI-2517, an investigational inhibitor of plasminogen activator inhibitor 1 (PAI-1).

SSc is a rare, chronic autoimmune disease. With a median survival rate post-diagnosis of five to eight years, the condition causes the skin and internal organs to harden and thicken. ILD is an umbrella term characterising diseases that cause scarring (fibrosis) of the lungs.

The two conditions have been parcelled into the same study given that ILD is a common and usually early comorbidity of SSc in which the excessive production of PAL-1 has been implicated.

Under normal physiological circumstances, PAL-1 plays a key role in wound healing. However, excessive PAL-1 activity promotes fibrosis by disrupting the usual ordered process of wound healing and may enhance inflammatory cell infiltration through direct interaction with cellular integrins.

MDI will also monitor changes to total and active PAL-1 during its study, given that its preclinical data has suggested that MDI-2517 can present a range of functional outcomes to reduce pathologic levels of PAI-1 to normal physiologic levels and deliver therapeutic reductions in pro-inflammatory and pro-fibrotic processes.

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MDI believes this factor may be especially relevant to the development of pulmonary fibrosis, as PAI-1 has been shown to promote the recruitment of exudate macrophages to the lung and to induce pro-fibrotic polarisation in macrophages.

“Based on comprehensive preclinical studies, this first-in-human study of MDI-2517 will inform the continued development of our novel, proprietary compound for the potential treatment of systemic sclerosis and interstitial lung disease,” said MDI Therapeutics CMO Mark Weinberg.

“Beyond these initial indications, the outcomes of the Phase I trial will also support the potential evaluation of MDI-2517 in other chronic fibrotic and inflammatory diseases that have been associated with excessive PAI-1 activity.”

Last year, aTyr Pharma dosed the first patients in a Phase II SSc trial of Efzofitimod, a first-in-class biologic immunomodulator designed to selectively modulate activated myeloid cells through neuropilin-2 (NRP2) for resolving inflammation without immune suppression and preventing fibrosis progression.

In 2022, Michigan-based MDI completed a $9m Series A venture financing round.

There are 416 clinical trials for ILDs at various stages globally, as per GlobalData’s Clinical Trials database.