Orexa

Orexa B.V. is a clinical-stage pharmaceutical company based in Herpen, the Netherlands, that was founded in 2016 by Professor Dr. Ard Peeters. The company's inception is rooted in a surprising discovery by Prof. Peeters: the local administration of an anesthetic in the stomach, contrary to decreasing food intake as expected, actually led to increased consumption in test animals. This finding was subsequently confirmed in multiple studies with animals and healthy human volunteers, leading to the core mission of Orexa.

The company is focused on developing and commercializing therapeutics designed to increase food intake, addressing significant unmet medical needs. Orexa's business strategy leverages the 505(b)(2) regulatory pathway, which allows for a more streamlined development process by using existing data on previously approved active ingredients, resulting in a less expensive and faster route to market. This approach is centered around its lead compound, ORE-001, a proprietary oral formulation of a well-known anesthetic. The company has secured its intellectual property with patents for the mechanism of action and for its innovative tablet formulation.

Orexa's clinical development program is actively investigating ORE-001 across three primary indications. A major milestone was achieved on January 11, 2024, when the first patient was dosed in a multi-center, double-blind, placebo-controlled Phase 2a trial in Germany to evaluate ORE-001's efficacy in preventing post-operative ileus in patients undergoing major abdominal surgery. This condition, a prolonged absence of bowel function, can affect up to 50% of surgical patients, hindering recovery and extending hospital stays. The company is also advancing a second Phase 2 trial for patients with anorexia nervosa, with patient dosing anticipated in the latter half of 2024 in a specialized clinic in Italy. A third Phase 2 study is in preparation for elderly individuals with malnutrition, specifically sarcopenia/cachexia. By targeting these conditions, Orexa aims to demonstrate that increasing food intake can lead to improved patient health, shorter hospitalization, and significant healthcare cost savings.

Financially, Orexa has successfully raised capital through multiple funding rounds from undisclosed informal investors, including €1.2 million in August 2022, €485,000 in January 2023, €870,000 in January 2024, and €340,000 in June 2024, bringing its total funding to over €3.3 million. These funds are being used to advance its clinical trial programs. The management team includes founder Prof. Dr. Ard Peeters as CEO and CSO, who brings a background as a biologist with a Ph.D. in Psychology and experience at Organon, and Sake Stevenhaagen as CFO, an actuary who was an early investor in AM-Pharma.

Keywords: Orexa, ORE-001, food intake stimulant, post-operative ileus, anorexia nervosa, cachexia, sarcopenia, 505(b)(2) pathway, clinical-stage pharmaceutical, oral formulation anesthetic, Ard Peeters, Sake Stevenhaagen, malnutrition, drug development, Herpen Netherlands, life sciences, appetite stimulant, metabolic disease, therapeutic development, gastrointestinal motility