Regeneron Pharmaceuticals has shared positive results from a late-stage trial of Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery.

The phase 3 C-POST trial has been comparing adjuvant treatment with the PD-1 inhibitor against placebo in patients with features associated with a high-risk of CSCC recurrence and who have completed surgery and post-operative radiation therapy.

CSCC is the second most common type of skin cancer, with approximately 1.8 million cases diagnosed in the US every year.

Libtayo is designed to block cancer cells from using the PD-1 pathway to suppress T-cell activation and already holds approvals to treat certain patients with advanced CSCC.

C-POST met its primary endpoint of disease-free survival, with adjuvant Libtayo demonstrating a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to adjuvant placebo.

The trial will continue for additional follow-up, Regeneron said, adding that it is planning to file a submission with the US Food and Drug Administration for Libtayo in this indication in the first half of 2025.

Photodynamic therapy (PDT) specialist Biofrontera has announced that the final patient in its phase 3 skin cancer trial completed the study’s one-year follow-up visit.

The company previously reported “highly statistically significant” results for all primary and secondary endpoints and said the new one-year data for Ameluz-PDT will be included in its submission to the US Food and Drug Administration, which is expected in the third quarter of 2025.

Basal cell carcinomas (BCCs) arise from abnormal, uncontrolled growth of basal cells at the bottom of the epidermis and are the most common form of skin cancer, with approximately 3.6 million cases diagnosed in the US every year.

They rarely spread beyond the original tumour site but, if untreated, can become locally invasive, grow wide and deep into the skin, and destroy skin, tissue and bone.

The late-stage ALA-BCC-CT013 study evaluated the safety and efficacy of Ameluz-PDT in combination with the RhodoLED lamp in patients with one or more clinically and histologically confirmed superficial BCC.

Patients received either Ameluz-PDT or placebo-PDT one to two weeks apart and repeated after three months if required.

The US Food and Drug Administration (FDA) and Health Canda have granted Investigational New Drug (IND) and Clinical Trial Application clearance, respectively, to Alys Pharmaceuticals’ phase 2a alopecia areata study.

The trial will evaluate the safety and efficacy of Alys’ intradermal injectable JAK1 siRNA-lipid conjugate, ALY-101, at five sites across the US and Canada.

Approximately 700,000 people in the US currently have some form of alopecia areata, an autoimmune disease characterised by patchy or complete hair loss on the scalp, face or other parts of the body.

Although alopecia areata can begin at any age, most patients develop the condition earlier in life, with more than 80% experiencing symptoms before the age of 40 and 40% by the age of 20.

ALY-101 is the first clinical candidate to emerge from a multiyear joint research collaboration between Alys and the RNA Institute of UMass Chan Medical School focused on developing siRNA therapies for dermatological use.

The phase 2a trial also marks the first clinical study from Alys’ pipeline, which also includes assets targeting atopic dermatitis, chronic spontaneous urticaria, vitiligo and systemic mastocytosis.

LEO Pharma and non-profit organisation DEBRA Research have announced a collaboration aimed at accelerating the development of treatments for epidermolysis bullosa.

The non-exclusive strategic partnership will combine LEO’s experience in medical dermatology with DEBRA’s focus on epidermolysis bullosa patient care and pharmaceutical experience.

While financial details of the alliance have not been disclosed, the partners said they are hoping to “enhance scouting capabilities and provide additional capacity to accelerate the development of life-changing therapies for epidermolysis bullosa”.

There is currently no cure for epidermolysis bullosa, a group of rare and painful inherited skin disorders that cause the skin to become very fragile and tear or blister very easily.  Treatments are limited to relieving symptoms and preventing complications developing, such as infection.

Jacob Pontoppidan Thyssen, chief scientific officer and executive vice president at LEO, said: “Having personally cared for patients with severe epidermolysis bullosa, I have experienced the devastating consequences first-hand.”

He continued: “We are proud to collaborate with DEBRA Research, whose vast experience in the pharmaceutical industry and commitment to advancing medical research are invaluable. Together, we can do so much more.”