- Vanda Pharmaceuticals on Monday rolled out positive Phase 2 data supporting its experimental drug for gastroparesis, a condition that's gone without new treatment options for nearly four decades.
- The drug candidate, tradipitant, is an NK-1R antagonist that Vanda licensed from Eli Lilly in 2012. Company executives said the therapy showed a statistically significant effect in helping patients with gastroparesis, a relatively rare chronic medical condition that typically results in nausea, vomiting and stomach pain.
- The stock market rewarded the Washington-based pharma Monday, with shares up 25% following the readout. Vanda has had a solid year on the market, roughly doubling in share price from $15 to $32 since the beginning of 2018.
Vanda is betting tradipitant can lead its late-stage pipeline and eventually supplement revenue from its two products currently on market, Hetlioz (tasimelteon), for non-24-hour sleep-wake disorder, and Fanapt (lloperidone), a schizophrenia treatment. Those two combined for $140 million in sales through the first nine months of 2018.
Positive efficacy and safety from this Phase 2 study bodes well for tradipitant's future, particularly considering the only treatment for gastroparesis, metoclopramide, was approved by the Food and Drug Administration in 1979. That drug carries a black box warning that states it can cause an irreversible and severe movement disorder and recommends a 12 week maximum on use.
That dearth of new treatment options has pushed up Wall Street estimates of the commercial opportunity ahead of Vanda. Jefferies sell-side analyst Chris Howerton eyed potential peak sales of tradipitant of nearly $900 million if the drug can win a gastroparesis indication from the FDA, he wrote in a Dec. 3 investor note.
Tradipitant's performance on the study's main and key secondary endpoints
|Endpoint||Tradipitant (n=73)||Placebo (n=68)||P value|
|Daily diary nausea score (0-5)||-1.25||-0.73||0.0099|
|% of nausea-free days||28.8%||15.0%||0.0160|
Responding to the Phase 2 data, the investment bank increased its expectation of tradipitant's chances of approval to 70% and anticipates a New Drug Application in about two years. Tradipitant is also undergoing a Phase 3 trial in atopic dermatitis.
As part of its licensing deal with Eli Lilly in 2012, Vanda noted in a recent Securities and Exchange Commission filing it could still owe potential milestone payments of $97 million to the pharmaceutical giant, mainly related to the drug's commercialization.
Next steps for Vanda will be presenting the data at a conference and publishing the full data in a peer-reviewed journal. While the company's chief executive demurred in giving specifics on a Dec. 3 conference call, he mentioned the possibility of presenting as a late-breaker at Digestive Disease Week, which is set for May 2019.
Vanda, which CEO Mihael Polymeropoulos founded in 2003 after working at Novartis, has grown in recent years since Hetlioz gained FDA approval in 2014. Its number of full-time employees has increased from 64 at the end of 2014 to 274 at the end of last year, according to Securities and Exchange Commission filings.