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Clinical Trial Results Prove Positive For Samumed

Samumed, the San Diego biotech with a $12 billion valuation, has wrapped up a mid-stage clinical trial that has the company optimistic about its future.

The trial was a Phase 2 study for its osteoarthritis drug (one of the programs investors were most intrigued by in its latest valuation). The hope is that the treatment, called SM04690, will re-grow the cartilage in patients’ knees.

Over 20 million Americans suffer from osteoarthritis as the cartilage that cushions their joints wears away. There’s no real treatment besides pain medication, which can exacerbate the problem (feeling less pain, patients tend to move around more and wear down that cartilage even more).

Samumed’s drug could potentially re-grow this cartilage with its drug.

“Anybody who can grow cartilage safely will be bigger than Apple,” said Finian Tan, an investor in Samumed and chairman at Vickers Venture Partners, in an email last year.

The company has just completed Phase 2 human trials of the drug. The trial went for a full year — or 52 weeks — and included 455 patients with moderate-to-severe osteoarthritis of the knee. The subjects received a single injection.

Samumed presented interim data (from the first half of the trial) last month at a conference in Spain, stating that the product appeared to re-grow cartilage (as demonstrated by increased space observed in the medial joint on an x-ray).

Now that the trial has concluded, Samumed said the drug appeared to be safe and well-tolerated.

The company’s CEO Osman Kibar said in an email Friday that the company plans to present data on the efficacy of the drug later this year, but did confirm that the 52-week results continued to improve from the interim data presented halfway through.

Samumed is planning to start its late-stage, pivotal studies in the first quarter of 2018, so big things could be ahead for this local biotech.

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