Hyloris Pharmaceuticals expands its Pipeline with a Product Candidate for a Mineral Deficiency in the Blood

Hyloris Pharmaceuticals SA, a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, has announced it has in-licensed a product candidate targeting hypophosphatemia. This serious condition causes patients to have a low level of phosphorous in the blood.

While mild hypophosphatemia is common and many patients are asymptomatic, severe hypophosphatemia can be life-threatening and requires medical treatment. The condition can result in different health challenges, including muscle and bone weakness, respiratory or heart failure, seizures or coma. Deficiency of this vital mineral is always linked to an underlying condition, such as diabetes, anorexia, use of diuretics or alcohol abuse.

Stijn Van Rompay, Chief Executive Officer of Hyloris, commented: “It’s a source of pride for us to ensure that drugs administered to patients are accompanied by clear instructions and have demonstrated clinical efficacy and safety. A registered product entails the treatment has been validated by regulators, which ensures fast and equal access and offers peace of mind to physicians and patients.”

“The expected costs for Hyloris stay well below our required average investment of less than EUR 7 million per product candidate. This interesting new opportunity brings us one step closer to a total pipeline of 30 assets, a goal we aim to achieve before 2025.”

Treatment protocols for patients deficient in phosphate are well-established and have proven useful in other situations of bone mineral imbalance. Oral administration is the preferred way of treating hypophosphatemia, although in most countries no approved drugs exist. Currently, physicians mostly rely on compounded drugs which have, by definition, not been submitted for regulatory scrutiny regarding safety, efficacy, and quality.

Hyloris will seek advice and approval from regulators by making use of the rich body of clinical data that has emerged from established clinical practice. With a primary on safety of the product, Hyloris intends to conduct a streamlined development program to achieve market access in Europe, targeting regulatory approval in European countries as from 2026. Global rights of the ongoing development have been licensed-in from Dutch company, QliniQ, who maintains the rights to commercialize the product candidate in its home country, and a selected number of Middle Eastern and developing countries. The external development cost including the licensing fee is expected to remain below EUR 2 million. Besides agreed upon product development costs that will be incurred, no further payments will be owed to QliniQ.

Albert de Bruin, Managing Director of QliniQ, added: “Thanks to Hyloris and its demonstrated expertise in bringing new drugs to international markets, our product candidate could help many more patients. We have tremendous confidence in Hyloris’ ability to navigate the regulatory path towards improved patient outcomes.”

Separately, Hyloris has divested HY-038 to QliniQ for a price of EUR 1 million. This generic product was considered a non-core asset by Hyloris. This transaction highlights once again an increased focus on value-added repurposed or reformulated product candidates.