The technology behind CLINUVEL’s lead drug, SCENESSE® (afamelanotide 16mg), has been in research and development since the 1980s when a small team of scientists set out to investigate methods of preventing skin cancer in humans. CLINUVEL licensed this technology and has spent over A$20million optimising the chemistry of afamelanotide (the active ingredient in SCENESSE®) and developing a proprietary, controlled-release implant formulation.
Since late 2005, CLINUVEL has focused on developing SCENESSE® as a dermatological drug for individuals at greatest risk from visible and ultraviolet (UV) light and as a repigmentation therapy. The company has a particular focus on diseases where no existing preventative treatment exists.
CLINUVEL commenced a clinical program in 2006 which focused on the rare disease erythropoietic protoporphyria (EPP), a metabolic disorder which causes painful burning reactions under the skin after even brief exposure to sunlight. The goal of CLINUVEL’s EPP program is to prove that SCENESSE® can provide patients with EPP protection from sunlight by reducing the incidence and severity of EPP reactions. The ultimate objective is to provide a better quality of life for patients. Since the start of the EPP program, the company has involved more than 250 individuals with EPP in its global clinical trials. Between 2005 and today, clinical programs have also been conducted for individuals diagnosed with a range of disorders, including polymorphous light eruption, solar urticaria and organ transplant recipients who are susceptible to an extremely high rate of skin cancers.
In late 2009, CLINUVEL announced that it had expanded its pipeline to include a second drug candidate, named CUV9900. Based on the same technology as SCENESSE®, CUV9900 is still in early stage development.
2010 was a pivotal year for CLINUVEL. In May 2010, SCENESSE® became the first dermatological drug listed under the Italian 648/96 law, prior to its formal approval anywhere in the world. This listing allows Italian physicians to prescribe SCENESSE® to individuals with EPP with the cost of the drug reimbursed by the Italian National Health System (Sistema Sanitario Nazionale, SSN).
Later in 2010, CLINUVEL also announced that it would expand its program for SCENESSE® to investigate the drug’s ability to repigment skin in the common pigmentation disorder vitiligo. Following regulatory and ethical approvals, CLINUVEL’s International SCENESSE® Pilot Repigmentation Evaluation (INSPIRE) program commenced patient recruitment in 2011. A Phase II study was completed in the USA in 2013, showing that the drug had a good safety profile in vitiligo and may assist in faster repigmentation in patients when used in combination with narrowband UVB phototherapy. A Phase IIb study of the drug in vitiligo commenced in 2014 in Singapore.
In February 2012 CLINUVEL lodged its first marketing authorisation application for SCENESSE® for EPP with the European Medicines Agency. In December 2014 the European Commission approved SCENESSE® for the prevention of phototoxicity in adult EPP patients.
As of December 2014, more than 900 individuals have been administered afamelanotide in CLINUVEL’s clinical trials program and through compassionate use and special access schemes. To date, the drug has maintained a good safety profile in clinical trials.