Results

Mixed data doesn’t stop this biotech unicorn from plotting a looming PhIII showdown

Samumed has often found it easier to come up with lots more investor cash than consistently positive clinical data. And that odd juxtaposition has never been more apparent than in its latest readout for their lead drug in the pipeline.

Two months after raising a jaw-dropping $438 million at a $12 billion valuation, the biotech has come up with a distinctly mixed batch of Phase IIb data on SM04690. But that won’t stop this unicorn from barreling into a late-stage study in search of an FDA OK.

The drug — a Wnt pathway inhibitor — is designed for osteoarthritis, fitting easily into a broad pipeline that includes therapies of everything from hair loss to psoriasis and Alzheimer’s.

In this latest study, investors injected the drug directly into the knees of patients feeling considerable pain from their condition — with the investigators looking closely at patient reported outcomes.

One of their doses — 0.23 mg — hit for pain and function in statistically significant PRO ratings. One lower dose hit on one measure for pain while two doses didn’t hit anything. And all 4 doses failed to score on a key primary outcome: an improvement in medial joint space width over 24 weeks, though they hit it at 52 weeks in an earlier study.

Company execs told Business Insider that the 24-week study was just too short a period to expect a significant improvement, which they plan to factor into the Phase III.

If it was a public company, that mixed data would likely trigger some nausea in investors. But Samumed is still notably private, so they don’t have to manage any market symptoms for now.

“The safety profile, the improvements in signs and symptoms, and the disease-modifying benefits of SM04690 that we have observed in this Phase IIb as well as earlier studies, are quite promising,” said Osman Kibar, CEO of Samumed. “We look forward to working with the FDA to take SM04690 into Phase III pivotal trials, targeting a start date in early 2019.”


Image: Osman Kibar


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