CLINUVEL (ASX: CUV) is implementing one of several operational changes by prioritising its resources towards three key areas of clinical development: vitiligo, adrenocorticotropic hormone (ACTH) and the porphyrias (EPP and VP).
With this decision, the clinical programmes in stroke, Parkinson’s disease (PD) and xeroderma pigmentosum (XP) will be temporarily suspended and all internal resources deployed to the programs with the highest probabilities of, and fastest routes to, regulatory and commercial success.
Decision to strategically prioritise three key clinical programmes
The Board of Directors has unanimously decided to redefine CLINUVEL’s objectives based on new information while streamlining the current operations. On the basis of a range of factors and analyses, including new clinical guidelines in CNS disorders, chances of reimbursement, and the need to use internal resources more efficiently, the company will focus on lead programs with highest need and largest market opportunity.
CLINUVEL’s Board has also determined that a consolidation of the Group’s activities will result in more RD&I2 catalysts, which public markets will find easier to follow with progression along valuable milestones.
In addition to the three core clinical programsme, CLINUVEL’s non-pharmaceutical PhotoCosmetic product development continues, with the Company preparing launches of three product lines. CLINUVEL’s existing team is being redeployed to maximise efficiency.
Commercial opportunities for melanocortins
CLINUVEL has established itself as a world leader in developing and commercialising melanocortins, peptides which play a key role in human physiology.
The company’s first melanocortin technology – the novel drug SCENESSE (afamelanotide 16mg) – has been established as the standard of care in porphyria (EPP). VP is one of the expansion programmes where SCENESSE assists patients in reaching a better quality of life. CLINUVEL completed a Phase II VP study during 2024 and is currently designing a late-stage confirmatory program for regulatory feedback.
Vitiligo affects 1-2% of the general population. It is generally anticipated that the vitiligo market will be divided between those companies offering localised transdermal products (creams, ointments) and those few companies who propose a medical solution for extensive disease of depigmentation by providing systemic (total body) treatment.
CLINUVEL has established a clinical and regulatory pathway for SCENESSE as a treatment for patients with ≥10% body surface area affected by vitiligo, with a Phase III clinical program ongoing.
The ACTH market opportunity attracts attention for a number of central nervous system disorders. CLINUVEL has announced it will initially focus on evaluating ACTH as a treatment for patients with infantile spasms , some other types of severe epilepsy in children, and multiple sclerosis, which are all disorders with a high unmet medical need. The company is developing an instant release ACTH formulation as NEURACTHEL, with manufacturing updates provided periodically.
“This Board, with its newly appointed members, has deliberated extensively as to the short- and long-term objectives of the company,” Chair, Dr Jeffrey Rosenfeld said.
“By providing clear priorities we can accelerate development and generation of meaningful milestone news for public investors. Today’s decision is the first of a number of far-reaching changes that we invoke,” Dr Rosenfeld said.
“I personally witnessed the past five years within a large pharmaceutical conglomerate how considerable investments are easily abandoned to refocus clinical research teams on one or two sizeable opportunities,”