CLINUVEL Pharmaceuticals has announced the advancement of novel sustained-release liquid drug formulations into preclinical testing, marking a significant milestone after ten years of fundamental research and development at the company's fully-owned Singaporean laboratories, VALLAURIX. The biocompatible pharmaceutical formulations demonstrate potential for extending the duration of peptide drug release while optimizing patient exposure to active pharmaceutical ingredients.
Decade of Research Yields Breakthrough Platform
The Australian specialty pharmaceutical company's formulation development program has focused on lengthening the duration that peptides remain detectable in blood levels while achieving predictable kinetics. According to the company, this approach aims to optimize patient exposure to active pharmaceutical ingredients while minimizing dosing requirements to achieve therapeutic effects.
"It has been challenging to realise the journey from drug delivery concepts to effective formulations containing the right drug loading, but recent reproducible in vitro results at VALLAURIX have given us confidence to pursue the preclinical program," said Dr. Dennis Wright, CLINUVEL's Chief Scientific Officer.
Flexible Dosing Technology
The sustained-release depot formulations offer a key advantage through their ability to facilitate flexible dosing by adjusting injection volumes. This feature enables delivery of peptides to infants, children, and adults according to body weight, potentially addressing a significant clinical need across different patient populations.
The liquid formulation technology represents an adaptable platform that can be tailored for different release profiles and clinical needs. If confirmed in vivo studies, the new depot formulations would serve as a delivery platform for various peptides, with an initial focus on melanocortins.
Clinical Timeline and Development Strategy
CLINUVEL has selected multiple drug product candidates for preclinical evaluation, with the preclinical program for the first formulations expected to complete in the second half of 2026. Following preclinical evaluation, the company will make decisions regarding manufacturing of the products for human evaluation.
"We have progressed research in a cost-effective manner, with an approach that may provide substantial options for drug delivery in general," Wright noted, emphasizing the platform's potential broader applications beyond the company's current therapeutic focus areas.
Company Background and Existing Portfolio
CLINUVEL operates as a global specialty pharmaceutical group focused on developing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders. The company pioneered photomedicine and melanocortin peptide research, leading to innovative treatments for patient populations requiring systemic photoprotection, assisted DNA repair, and repigmentation therapies.
The company's lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world's first systemic photoprotective drug. The treatment prevents phototoxicity, including anaphylactoid reactions and burns, in adult patients with erythropoietic protoporphyria (EPP).
Headquartered in Melbourne, Australia, CLINUVEL maintains operations across Europe, Singapore, and the United States, positioning the company to advance its novel drug delivery platform through global development and commercialization networks.
