Takeda Hits the Brakes on Narcolepsy Drug Trials

Takeda was quick to hit the pause button on part of its narcolepsy program after a safety signal was detected in Phase 2 trials of TAK-994, an investigative treatment for narcolepsy.

While the Japanese drugmaker did not provide additional details on the safety concern, it has suspended the dosing of patients in two Phase 2 trials involving TAK-994. The company said stopping early would allow it to take a benefit-risk assessment of the drug.

“Ensuring the safety of patients participating in clinical studies is of the utmost importance as we strive to develop transformative medicines. We are grateful to all of the patients, physicians, and site staff who participated in these important clinical trials,” said Sarah Sheikh, Head Neuroscience Therapeutic Area Unit at Takeda.

“Takeda is committed to bringing innovative, safe, and effective treatments to patients with narcolepsy. We are working to quickly assess the totality of available data to inform the further development of TAK-994.” This is quite an upset for Takeda; it was hoping to wrap up the two Phase 2 trials on TAK-994 in early to mid-2022.

High Hopes for TAK-994

No cure exists for narcolepsy, a long-term brain disorder characterized by excessive daytime sleepiness and sudden loss of voluntary muscle control (cataplexy) while awake. Narcolepsy is caused by a deficiency of orexin, a neurotransmitter that helps sustain alertness.

TAK-994 is an oral orexin agonist designed to help people with narcolepsy stay awake during the day. It works by stimulating orexin receptors to reproduce the effects of orexin. Early trials showed that the drug was well-tolerated and improved wakefulness in patients with narcolepsy.

Phase 2 trials of TAK-994 began in early 2020, enrolling patients with narcolepsy with or without cataplexy. Takeda scooped up a Breakthrough Therapy designation for TAK-994 from the FDA in July 2021. Takeda considers TAK-994 as part of its Wave 1 pipeline, drugs the company hopes would make up most of its revenue growth. Data analytics company GlobalData estimates TAK-994 could generate global sales of $654 million by 2027.

Despite the latest setback to Takeda’s most advanced candidate to treat narcolepsy, the company plans to forge ahead with other oral orexin assets, such as TAK-861, which is in Phase 1 trials.

NLS Pharmaceutics’ Quilience Could Take Lead in Orexin Race

With TAK-994 on the backburner, attention is shifting to what could be its closest competitor. Quilience, an oral tablet developed by NLS Pharmaceutics, last month began enrolling patients in its Phase 2 trial. NLS’ drug, like TAK-994, tries to treat narcolepsy by stimulating the orexin receptor.

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Joy Lin

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