Pharmaceutical Market Europe • October 2025 • 11
DERMATOLOGY NEWS
Pelage Pharmaceuticals’ alopecia treatment moves forward to phase 3 trial
Pelage Pharmaceuticals is advancing PP405, its lead candidate for the treatment of androgenetic alopecia, into phase 3 trials.
PP405 is a first-in-class, non-invasive, topical small molecule therapy designed to stimulate dormant hair follicle stem cells and promote new hair growth.
Daniel Gil, CEO of Pelage Pharmaceuticals said: “Hair loss...affects more than 80% of men and 40% of women throughout their lifetimes.”
The company reported positive interim results from a randomised, placebo-controlled phase 2a trial in July 2025. The results showed that PP405 met its primary safety endpoint and demonstrated a clinically meaningful improvement compared with current treatments for androgenetic alopecia.
After completion of this phase 2a trial, patients in the placebo group were offered enrolment in a three-month open-label extension to evaluate long-term safety. A full data set from the trial is expected to be shared by the company at a future medical meeting in 2026.
Based on the strong safety profile and initial efficacy observations, Pelage plans to initiate a phase 3 trial in 2026 to further assess the safety and efficacy of PP405 in androgenetic alopecia.
La Roche-Posay launches global campaign to spotlight the visible and invisible impact of scars
La Roche-Posay has launched a global awareness campaign, ‘Scars of Life’, to highlight the psychological and social effects of scars and chronic skin conditions.
Earlier this year, the World Health Organization (WHO) recognised skin health as a global public health priority, underscoring the need to address the stigma, anxiety and emotional distress skin diseases can cause. It is estimated that around two billion people worldwide live with skin conditions.
The Scars of Life campaign includes a global research study involving 30,000 patients across 27 countries. Findings to date indicate that 71% of acne patients report reduced self-confidence, 47% of eczema patients prefer to hide themselves, and 50% of cancer patients interrupt treatment due to skin-related side effects. Additional evidence presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress also revealed an elevated risk of suicidal thoughts among patients with chronic skin disease.
La Roche-Posay hopes the campaign will encourage clinicians, researchers and policymakers to adopt a more integrated approach to skin health – one that recognises the psychological as well as the physical impact of skin conditions.
J&J’s Tremfya approved by FDA for children with plaque psoriasis and psoriatic arthritis
Johnson & Johnson’s Tremfya has been approved by the US FDA for children aged six years and older, following positive data from multiple phase 3 studies.
The treatment is now indicated for children with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, as well as for children with active psoriatic arthritis (PsA).
Each year, approximately 20,000 children under the age of ten are diagnosed with plaque PsO in the US, while active PsA affects an estimated 14,000 children.
Tremfya is the first – and currently only – IL-23 inhibitor approved by the FDA for children. The decision extends the drug’s approved use, having received FDA clearance for adults with plaque PsO in 2017 and for PsA in 2020.
The plaque PsO approval was based on results from a phase 3 study in paediatric patients with moderate-to-severe plaque PsO and supportive data from two phase 3 studies in adult patients with moderate-to-severe plaque PsO.
Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from TREMFYA PsO and PsA studies.