With an FDA decision looming, Flexion touts new data spotlighting a safety edge for osteoarthritis drug

Now that Flexion $FLXN is less than four months away from an FDA decision on its new osteoarthritis drug Zilretta (FX006), the biotech has floated some new data from a tiny mid-stage study that it’s hoping will find its way into the label.

The Burlington, MA-based group turned up at the ADA meeting in San Diego over the weekend to say that it now has data to prove that its drug is not associated with the same spikes in blood glucose that diabetics commonly experience when they get a steroid shot in an aching joint. And they’re looking to use it to gain a leg up in a sizable market.

Steroid shots are well known for pushing up blood glucose into the danger zone, however briefly, so it was to be expected that researchers could chart a distinctive break between Flexion’s drug and the injections known to deliver fast and cheap relief to patients who suffer from osteoarthritis.

Researchers only recruited 33 patients for this, finding that Zilretta had significantly less impact on blood glucose levels (14.7 mg/dL) compared with steroids (33.9 mg/dL).

Mike Clayman

“You don’t have to be a scientist to see there is a difference,” says Flexion CEO Michael Clayman, pointing to their chart tracking the impact of steroid shots verses their late-stage therapy. “The full study report was filed with the NDA. We propose reference to these data in Zilretta not being associated with a spike in glucose.”

The patient groups are tiny in this study, but the market numbers Clayman has in mind are huge. More than 4 million people suffering from osteoarthritis get these steroid shots, he adds, and 20% of them have diabetes — about 800,000 patients. Having some data that illustrates the differentiation in the blood glucose profile, — where hyperglycemia, even quickly flushed away as it is with steroids, is to be avoided wherever possible —could help persuade vigilant payers to opt for a much more expensive branded therapy.

Flexion has been focused more and more on their October PDUFA date for Zilretta. The biotech’s been steadily building out a commercial operation, Clayman tells me, lining up job offers for 80 to 100 sales reps as they keep their fingers crossed that the FDA will come through with an approval.

Close to three months ago, FiercePharma reported that Sanofi was angling for a Flexion buyout, looking to bag a drug now under review. The connection made sense, considering Sanofi’s work in diabetes and a big need to beef up the portfolio of drugs. But so far, nothing has happened on that front and Flexion raised more cash recently, selling shares in a move that cast doubt on the prospects of a deal.

I asked Clayman about the report, which I followed up on, but he only told me the same thing he’s told everyone else who has asked: The company doesn’t comment on market rumors.

Company execs, though, are happy to discuss its prospects for cracking a big market, with its stock trading below where it was ahead of the buyout buzz. And that’s where we will leave it — for today.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Flatiron Health New York City or San Francisco

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