Harmony Bio Doses First Patient in Phase 1 Trial of Novel Sleep Disorder Therapy

NEW YORK, NY – November 19, 2025

Harmony Biosciences has announced the dosing of the first participant in a Phase 1 clinical trial evaluating BP1.15205, a novel orexin 2 receptor agonist designed to treat narcolepsy, idiopathic hypersomnia, and other central disorders of hypersomnolence. This marks a significant step in the company’s strategy to expand beyond its existing product, WAKIX (pitolisant), and solidify its position in the sleep-wake disorder market.

Targeting the Root of Excessive Daytime Sleepiness

BP1.15205 represents a targeted approach to treating excessive daytime sleepiness. Unlike many existing therapies that manage symptoms, this investigational drug aims to address the underlying pathophysiology of these conditions by selectively activating the orexin 2 receptor. The orexin system plays a critical role in regulating wakefulness, sleep, and arousal. Dysfunction within this system is heavily implicated in narcolepsy, particularly narcolepsy type 1, where there is a loss of orexin-producing neurons.

“The development of a selective orexin 2 receptor agonist is a potentially significant advancement,” said one sleep specialist, speaking anonymously. “Current treatments often come with limitations in efficacy or side effect profiles. A drug that directly addresses the orexin system could offer substantial benefits for patients who struggle with debilitating daytime sleepiness.”

While stimulants and other wakefulness-promoting agents are available, they often operate through different mechanisms, such as dopamine or histamine modulation. This new approach could provide a more physiological and potentially more effective solution for patients, offering a greater impact on both wakefulness and alertness.

Expanding Beyond WAKIX: A Diversification Strategy

Harmony Biosciences has achieved success with WAKIX, a histamine 3 receptor inverse agonist approved for narcolepsy. However, the company recognizes the importance of diversifying its pipeline to reduce reliance on a single product and unlock further growth potential. BP1.15205 is a key component of this strategy.

Financial reports indicate that WAKIX generated approximately $560-570 million in revenue for Harmony in 2023. While a strong foundation, the company is actively investing in research and development to expand its portfolio. R&D expenses increased to $26.8 million in the third quarter of 2023, reflecting this commitment.

This isn’t merely a diversification play; the company is also aiming to address the considerable unmet needs within the hypersomnolence space. Existing treatments often fall short for a significant portion of patients, and conditions like idiopathic hypersomnia remain particularly challenging to manage.

“The current treatment landscape for idiopathic hypersomnia is limited,” explained another source familiar with the industry. “Patients often cycle through multiple therapies without finding adequate relief. A new, targeted approach like BP1.15205 offers a beacon of hope.”

A Competitive Landscape and the Promise of Innovation

The race to develop effective therapies for hypersomnolence is heating up. Several companies, including Takeda Pharmaceutical and Centessa Pharmaceuticals, are also pursuing orexin receptor agonists. Takeda's TAK-994 recently demonstrated positive Phase 2 results in narcolepsy type 1, while Centessa’s ORX750 is in preclinical development.

This competitive landscape underscores the potential of the orexin system as a therapeutic target. However, it also presents a challenge for Harmony Biosciences to differentiate BP1.15205 and establish a strong market position. The Phase 1 trial will be crucial in evaluating the drug's safety, tolerability, and pharmacokinetic profile.

Analysts suggest that the key will be demonstrating a clear advantage over existing therapies, whether through improved efficacy, a more favorable side effect profile, or a convenient dosing schedule. Harmony is hoping that BP1.15205's targeted approach and potential for once-daily dosing will appeal to both patients and physicians.

The licensing agreement for BP1.15205 originates from Bioprojet Pharma, with Teijin Pharma initially involved. Harmony secured exclusive rights for development and commercialization in the United States and Latin America. This collaborative structure demonstrates the growing trend of pharmaceutical companies partnering to accelerate innovation in specialized therapeutic areas.

Topline data from the Phase 1 trial are expected in 2026, which will provide a preliminary assessment of BP1.15205's potential. While still in the early stages of development, this investigational drug represents a promising step forward in the treatment of hypersomnolence disorders and a significant potential catalyst for Harmony Biosciences' continued growth.