Vanda’s Hetlioz Shows Efficacy in Treating Jet Lag on Transatlantic Flight Study

May 23, 2018

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2 min read

According to the American Sleep Association, nearly 93% of all travelers will experience jet lag at some point. The deleterious effects of jet lag appear to be directly proportional to the number of time zones crossed during travel and exacerbated by eastbound travel. 30 million US residents travel to overseas destinations annually.

Vanda Pharmaceuticals (Nasdaq: VNDA) announced results today from a two-phase, three-night, transatlantic study (the JET Study) showing that Hetlioz (tasimelteon) was effective in treating jet lag in travelers who flew from the US to the UK. The study supports positive results from previous clinical studies, including the Phase III results released in March 2018 from Vanda’s Phase III study of Hetlioz on 318 healthy patients subjected to an eight-hour circadian challenge, i.e., put to bed eight hours before their usual bed time. This is clinically comparable to crossing eight time zones in travel, which leads to jet lag in the vast majority of cases.

Source: Vanda Pharmaceuticals, Corporate Presentation, May 2018

The JET study was a two-phase transatlantic travel study, with an observational travel phase to establish baseline followed by a travel with treatment phase. Study participants traveled either five time zones from Washington, DC, to London, or eight time zones from San Francisco or Los Angeles to Londony. They stayed in London for three nights, receiving either Hetlioz 20mg or placebo each night before bedtime.

Hetlioz was shown to provide significant benefits across multiple measures including:

Improved total sleep time during the first 2/3 of the night (TST 2/3) of 76 minutes on night three (which was determined to be the night most disrupted by travel)
Improved cumulative sleep time (TST 2/3) of 131 minutes over the three nights
Improved patient impressions from a post sleep questionnaire

We note that the study was terminated before it reached the original enrollment goal of 90 patients, with only 25 patients completing both phases of the study “due to the complexity of the study.” While this is undoubtedly a small sample set, the results support previous Phase III studies that involved 768 patients.

Vanda received FDA approval for Hetlioz in 2014 for non-24-hour sleep-wake disorder. The company intends to file a supplemental NDA for the treatment of jet lag disorder during the second half of this year. In addition, the company has been marketing Fanapt for schizophrenia in adults since 2009.

Source: Vanda Pharmaceuticals, Corporate Presentation, May 2018

Vanda just completed a follow-on equity offering in March 2018, raising $108 million in gross proceeds at $17 for a post-money market cap of $871 million. Stock is trading just above that offering price at the time of this writing. Given the company’s numerous anticipated milestones for the rest of this year, we think that Vanda merits close scrutiny from growth investors.