Australian company CLINUVEL has announced several changes to prioritise its resources towards three critical areas of clinical development.
Vitiligo, adrenocorticotropic hormone (ACTH) and the porphyrias (EPP and VP) are the areas.
The company said it will temporarily suspend clinical programs in stroke, Parkinson’s disease and xeroderma pigmentosum with all internal resources deployed to the prioritised programs.
It said the board redefined the company's objectives based on new information. It will focus on leading programs with the highest need and largest market opportunity.
The company said its non-pharmaceutical PhotoCosmetic product development will continue.
CLINUVEL is developing and commercialising melanocortins. Its first melanocortin technology SCENESSE (afamelanotide) has been established as the standard of care in porphyria. VP is one of the expansion programs where SCENESSE can assist patients in achieving a better quality of life.
CLINUVEL has also established a clinical and regulatory pathway for SCENESSE as a treatment for patients with affected by vitiligo, with a Phase 3 clinical program ongoing.
“This Board, with its newly appointed members, has deliberated extensively as to the short- and long-term objectives of the company,” said CLINUVEL chair Dr Jeffrey Rosenfeld.
“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,” said CLINUVEL’s director of global clinical affairs, Dr Emilie Rodenburger.
“From analyses of CLINUVEL the past months it has become clear that we need to rationalise, using our talent in three clinical areas with the highest chance of success. We must best use carefully accumulated resources to accelerate vitiligo, ACTH and porphyrias. At first sight, this may go against a market’s expectation of more diversification, but we believe we have a sufficiently large portfolio with SCENESSE, PRÉNUMBRA (afamelanotide instant and modified release) and NEURACTHEL (ACTH), which will be reinforced by today’s decision.
“Our commitment to photomedicine remains strong, and we will continue to support those communities severely affected by light and UV through the Photomedicine Foundation and other initiatives globally,” said Dr Rodenburger.