CLINUVEL Pharmaceuticals Ltd. reports news centered on photomedicine, melanocortin peptides and its American depositary receipt, CLVLY. Company updates frequently address SCENESSE (afamelanotide), including its established use in erythropoietic protoporphyria and clinical development as a systemic repigmentation therapy for vitiligo with narrowband ultraviolet B phototherapy.
Recurring developments also cover regulatory interactions with agencies such as the EMA and Health Canada, dermatology conference activity, preclinical work on sustained-release peptide formulations from CLINUVEL's VALLAURIX laboratories, and early research programs evaluating afamelanotide in additional disease areas. ADR-related updates may include foreign-issuer disclosure, program structure and U.S. market-access matters.
CLINUVEL (ASX: CUV; ADR Level 1: CLVLY) has launched CYACÊLLE, a new innovative polychromatic solar care product aimed at individuals at high risk of skin damage and cancer from ultraviolet (UV) and high energy visible (HEV) light. This product is now available through CLINUVEL’s e-commerce platform in Europe. CYACÊLLE is a leave-on cream designed for those frequently exposed to harmful solar radiation, including individuals with a history of skin damage or who are immune-suppressed. This launch follows decades of research and represents the first of four planned product lines focused on systemic photoprotection.
MELBOURNE, Australia, Feb. 24, 2023 - CLINUVEL reported a strong financial performance for the half-year ending December 31, 2022. Revenues rose by 19% to $29.36 million, driven by increased demand for SCENESSE®. Net profit after tax surged 94% to $11.39 million, marking the highest December half-year profit. Basic earnings per share reached $0.230, up 93%. The company maintained a robust balance sheet, with cash reserves growing 16% to $140.7 million. CLINUVEL aims to remain within its projected expenditures of $175 million until June 2025, emphasizing fiscal discipline and expansion into new markets.
CLINUVEL's afamelanotide has shown promising results in a recent clinical study, CUV151, where a single dose significantly reduced skin damage from ultraviolet (UV) radiation in nine healthy volunteers. Conducted in Melbourne, the study indicated a statistically significant decrease in UV-induced erythema (p=0.018) and an increase in minimal erythemal dose. The findings contribute to CLINUVEL's ongoing efforts to evaluate afamelanotide for high-risk individuals, particularly those with xeroderma pigmentosum (XP). The company expects final results from this study and additional findings from its DNA Repair Program later in 2023.
CLINUVEL recently announced promising clinical trial results for afamelanotide, a drug aimed at treating xeroderma pigmentosum (XP), a rare genetic disorder that significantly increases skin cancer risk. The trial, initiated in 2020, demonstrated that treatment with afamelanotide reduced DNA damage markers associated with UV exposure in adult XP patients. Key findings included a decrease in CPDs and improved markers like p53 and γH2AX. These results suggest potential applications for broader populations at risk for skin cancer, enhancing the scientific rationale for further studies on afamelanotide.
CLINUVEL Pharmaceuticals announces further studies for afamelanotide, a potential therapy for vitiligo, affecting 45 million globally, particularly in darker-skinned individuals. The drug, already approved for a rare light intolerance disorder, showed promise in earlier trials for repigmentation. The new clinical program, CUV104, will commence in North America during the summer months with a focus on safety and repigmentation, involving nearly 100 patients treated to date. Preliminary results are expected by late 2022.
CLINUVEL Pharmaceuticals has announced positive results from its CUV801 clinical study evaluating afamelanotide for treating mild to moderate arterial ischemic stroke. The study, which involved six patients, revealed that five of them showed significant improvement in NIHSS scores, with brain scans indicating reduced affected tissue. Afamelanotide was deemed safe, with no drug-related adverse events noted. The results suggest potential for afamelanotide as an effective treatment option post-stroke, addressing a critical unmet medical need in stroke care.
CLINUVEL shareholders are urged to remain resilient amid a significant decline in company value. Despite challenges, management emphasizes financial strength, with a historical focus on strategic growth and profitability since the commercialization of SCENESSE®. The management is optimistic about future advancements in photomedicine and attracting long-term institutional investors. In light of recent market volatility, the company aims to navigate through and maintain focus on its objectives, ensuring a sustained effort toward growth and shareholder value.
CLINUVEL Pharmaceuticals has announced the expansion of its drug portfolio with NEURACTHEL®, a new formulation of melanocortin adrenocorticotropic hormone (ACTH). The drug aims to address unmet medical needs in patients with neurological, endocrinological, and degenerative disorders. The company has secured a supply chain for ACTH and anticipates significant market growth, projecting sales to rise from $1.29 billion in 2020 to $1.91 billion by 2031. CLINUVEL's expertise in melanocortin development positions it well for this advancement.
CLINUVEL has expanded its clinical trials for SCENESSE® (afamelanotide 16mg) to assess its effects on patients with xeroderma pigmentosum variant (XP-V) and XP-C. The drug aims to demonstrate DNA repair capabilities in skin cells damaged by UV exposure, crucial for patients at a significantly higher risk of skin cancers. With agreements reached with global XP experts, the company is poised to generate clinical data on the safety and efficacy of this therapy.