CLINUVEL PHARMS LTD S/ADR - CLVLY STOCK NEWS

CLINUVEL has announced a new clinical program to evaluate afamelanotide as a treatment for early-stage Parkinson's Disease (PD) in fair-skinned patients. This innovative study aims to determine if afamelanotide can lower α-synuclein levels in blood and positively affect neurons in the midbrain through MC1R activation. The Phase IIa CUV901 study will involve six patients aged 40-85 and will assess the safety of afamelanotide while evaluating changes in blood α-synuclein levels and cognitive functions. Preclinical models have shown that afamelanotide could protect against α-synuclein toxicity, which is linked to neuron loss in PD. The trial has received ethics and regulatory approval, and patient enrolment is expected to start before the end of 2024.

CLINUVEL, a biopharmaceutical company, hosted a market briefing on its drug SCENESSE® and future plans. The company has shown profitability over seven years, commercialized SCENESSE®, and is investing in R&D, including a phase III trial for vitiligo treatment. The introduction of PhotoCosmetics lines aims to expand its reach.

CLINUVEL, a leading biotech company, recently garnered support from prominent investors and philanthropists at an event hosted by Lady Gaga and Michael Polansky. The event highlighted CLINUVEL's innovative melanocortin therapies that benefit patients at high risk of skin damage and cancer. The company's CEO unveiled future plans to expand their photomedicine technology into skincare products and treat various health conditions. CLINUVEL also announced the establishment of the Photomedicine Foundation to aid vulnerable patients globally.

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.