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Summary
- ASX 200 company CLINUVEL PHARMACEUTICALS LTD disclosed the progression of SCENESSE® (afamelanotide 16 mg) for the treatment of xeroderma pigmentosum.
- Following the announcement CLINUVEL share price skyrocketed, ending the session at A$21.510, up 9.243%.
- The Company anticipates reporting the first clinical outcomes from the DNA repair program in 2021.
- SCENESSE® shall first be assessed in XP-C patients who carry a defect in 3p25.1 gene as it is the most common XP form in the US and Europe.
At the end of today’s trading session, ASX 200-listed global biopharmaceutical company CLINUVEL PHARMACEUTICALS LTD’s (ASX:CUV) share price soared by 9.243% to A$21.510. The surge was driven by the Company’s announcement regarding the progression of SCENESSE® (afamelanotide 16 mg) for the treatment of xeroderma pigmentosum (XP).
The market capitalisation of the Company stood at A$972.89 million with almost 49.41 million shares trading on the ASX.
About CLINUVEL PHARMACEUTICALS LTD
CLINUVEL PHARMACEUTICALS LTD is a leader in the field of photomedicine. The Company’s R&D activities have led to innovative therapies for patients needing repigmentation and photoprotection. The Company is developing its portfolio of melanocortins, including PRENUMBRA®, to treat several critical conditions.
SCENESSE® for novel DNA Repair Development Program
On 10 September 2020, CLINUVEL disclosed the progression of SCENESSE® (afamelanotide 16 mg) for the treatment of XP or xeroderma pigmentosum.
The DNA repair development program intends to verify SCENESSE®’s ability to regenerate DNA of skin exposed to UV (ultraviolet) damage.
Xeroderma pigmentosum, or XP, is a rare genetic disorder expressing eight different genes (XPA to G, and V) that are engaged in the NER process. Xeroderma pigmentosum has a collective prevalence of nearly 1:450,000 in the European population. XP patients, because of the DNA repair proteins genetic deficiency, are 10k times more prone to skin cancer, including melanoma.
SCENESSE® will first be evaluated in XP-C patients who carry a flaw in 3p25.1 gene. XP-C patients are preferred since it is the most prevalent form of xeroderma pigmentosum in Europe and the US.
CLINUVEL is increasing its clinical research, intending to verify how intervention with the drug improves the removal of photoproducts as well as regeneration of DNA. The Company has already commercialised SCENESSE® in the United States and Europe for treatment of the rare genetic disorder porphyria (EPP).
Moreover, SCENESSE® is approved as an orphan drug in the European Union for the prevention of phototoxicity in adult patients having EPP.
After years of clinical experience with SCENESSE®, CUV is now hastening a thorough DNA Repair Program by first treating patients with xeroderma pigmentosum (XP).
CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright, stated-
CLINUVEL anticipates reporting the first clinical outcomes from the DNA repair program in 2021.
Below are six key highlights for the repair of DNA damage by SCENESSE®-
Staged Development Program of SCENESSE®
Scientific evidence validates the use of SCENESSE®’s active ingredient, afamelanotide for photoprotection and UV-induced DNA damage repair.
During the development of SCENESSE®, several categories of scientific evidence have been accumulated, and the main clinical objectives for SCENESSE® are-
- Systemic photoprotection to skin cells.
- Optimisation of the reaction of skin cells to ultraviolet radiation.
- Anti-oxidative capacity.
- Removal of photoproducts (chemical damage to DNA).
- Enhanced activity of DNA repair genes (as part of NER and/or BER).
- Decline of cell death (apoptosis) after UV exposure.
The image below illustrates how the DNA Repair Program has emphasised the safety of patients and volunteers exposed to afamelanotide over 10k doses in more than 1,400 subjects during 20 years of clinical use.
How DNA damage occurs?
The skin incurs DNA damage after exposure to ultraviolet. Non-ionising light enters the nucleus of skin cells and triggers distortions to the helix of DNA known as photoproducts.
If unrepaired, these chemicals lead to irreversible damage or photoaging. Moreover, these changes further progress to skin cancer, including melanoma.
Human biology includes complex mechanisms for protecting itself from damage induced by UV and restores cellular DNA into its original form.
People of fair-skinned complexion have defects in these UV protective and DNA regenerative methods, increasing their long-term risk of skin cancer.
Patients having XP, organ transplant recipients, including people of Anglo-Saxon origin with blue eyes, red hair and fair skin are at the maximum risk of developing skin tumours. These people have either defective or insufficient NER and BER, specifically a reduced capability for repairing damaged DNA.
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CLINUVEL Opens Vallaurix R&D Centre in Singapore
On 31 August 2020, the CLINUVEL Group updated the market with the opening of its state-of-the-art centralised R&D Centre in Singapore, operated by VALLAURIX PTE Ltd, a subsidiary of CLINUVEL.
The Company is focused on innovative fields of medicine with its subsidiary VALLAURIX developing drugs from melanocortins family & complementary OTC consumer products.
CLINUVEL stated that the new facility replaces the former laboratory which was launched in 2014.
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