Ann: FDA IND Approval for Phase 3 Study of DMX-200 in FSGS, page-16

Hi All,

Something interesting. Sparsentan has been accepted for priority review by the FDA for a NDA for IgA Nephropathy. This was off interim results in their Ph3 pivotal trial following 36 weeks of treatment. Sound familiar (as in trial design)?

https://www.globenewswire.com/news-release/2021/08/16/2280963/0/en/Travere-Therapeutics-Announces-Positive-Topline-Interim-Results-from-the-Ongoing-Phase-3-PROTECT-Study-of-Sparsentan-in-IgA-Nephropathy.html

https://www.globenewswire.com/news-release/2022/05/16/2443695/0/en/Travere-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Sparsentan-for-the-Treatment-of-IgA-Nephropathy.html

Travere’s FSGS Ph3 met primary endpoint data for interim analysis but the FDA wanted more data for priority review.

https://www.globenewswire.com/news-release/2022/05/17/2445474/0/en/Travere-Therapeutics-Announces-Presentations-of-Abstracts-at-the-59th-ERA-Congress.html

Both trials are ongoing. Travere announced a licencing deal with Vifor (CSL) for IgA Nephropathy last September. This is just for one kidney indication for Spartensan.

https://www.fiercebiotech.com/biotech/vifor-doles-out-55m-upfront-to-license-travere-s-late-stage-kidney-asset-slated-for

It’s been a long haul for Travere as well, but I guess patience pays off.

DMX-200 has been shown to be synergistic in pre-clinical work with endothelin A inhibitors eg sparsentan (ie replacing the ARB with Spartensan). Probably worth reflecting back on this.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02356811-3A564106?access_token=83ff96335c2d45a094df02a206a39ff4

GLTAH