Great data! Huge potential! (Too bad it failed the primary endpoint)

It’s not unusual for a biotech to cherry pick the most promising bits of data from a clinical study and lead with its best results when announcing trial results. So maybe it wasn’t too surprising that it took a little patience to find that Vanda Pharmaceuticals’ tradipitant actually flunked the primary in a Phase II study for chronic itch among atopic dermatitis patients.

Vanda execs had plenty of data points to choose from. There was a big advantage over placebo on Worst Itch Visual Analog Scale (VAS) — that made the headline results. But the pre-specified primary endpoint of Average Itch VAS?

No, we found out after we burrowed deep into the release. That didn’t work, with a messy p-value of 0.306.  Researchers blamed it on a high placebo response.

Vanda’s shares $VNDA skidded 6% lower in after-market trading on Wednesday as the red flag was spotted.

Nevertheless, Vanda execs felt that they were on the right track, touting a plan to move into a registration study after meeting with regulators and a look at trial designs. Confident that they can repeat the success, they’re offering investors the prospect of a frontline approval for atopic dermatitis, where Dupixent scored major improvement for patients.

Mihael Polymeropoulos, Vanda’s president and CEO, says he was “extremely pleased” with the data. The release didn’t capture his thoughts on the primary.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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