Soterios has announced the results of its phase 2 clinical trial that investigated the use of topical treatment STS-01 in patients with mild-to-moderate alopecia areata affecting less than 50% of their scalp.

More than 150 patients were randomised to receive one of four doses of STS-01 or placebo and treatment effect was measured based on improvement in the SALT score, a tool used to objectively measure scalp hair coverage.

Results showed that 75.9% of patients using STS-01 1% once daily achieved the study’s primary endpoint of a 30% or higher improvement in SALT score compared to 36.7% of those receiving placebo after 24 weeks.

In addition, 19% and 27% of patients on 1% and 2% STS-01, respectively, achieved total hair regrowth (SALT 0) compared to 3% receiving placebo, with a clear dose response identified.

Soterios also reported that the cream was well tolerated by patients and there were no major adverse events.

The company said it will share full results of the study at a future scientific conference and will now look to undertake a larger phase 3 study.

Almirall has announced that Klisyri (tirbanibulin) has received expanded approval from the US Food and Drug Administration (FDA) to treat actinic keratosis (AK), a common precancerous condition.

The approval follows the company’s supplemental new drug application to expand the use of the microtubule inhibitor ointment on areas of the face or scalp to up to 100cm2.

According to a recent survey by Almirall as part of AK Global Day 2024, AK has an estimated prevalence of 13.3% in Europe.

First approved by the FDA in December 2020, the recent approval was supported by an additional phase 3 clinical safety study involving more than 100 adult AK patients in the US, which met all primary endpoints.

Results for the safety and tolerability of Klisyri conducted on an area of 100cm2 on the face or balding scalp of patients was consistent with the original pivotal trials conducted on an area of 25cm2 for both local skin reactions and treatment-related adverse events, while also showing a quantified reduction in AK lesion count in line with the one reported in the original studies.

Novartis has shared positive long-term results from two late-stage studies evaluating its oral Bruton’s tyrosine kinase inhibitor remibrutinib in patients with chronic spontaneous urticaria (CSU).

Affecting approximately 40 million people worldwide, CSU is an unpredictable skin condition characterised by the occurrence of itchy hives and/or deep tissue swelling that last for six weeks or longer.

Antihistamines are often prescribed for CSU as they block histamine receptors and prevent the pro-inflammatory action of histamine, which causes itching and swelling. However, about half of patients are inadequately controlled by these alone.

In the phase 3 REMIX-1 and REMIX-2 studies, remibrutinib was associated with significant and sustained symptom improvement in CSU patients who remained symptomatic despite second-generation H1-antihistamine use.

The improvements with remibrutinib versus placebo, as previously shown at week 12, were confirmed at week 24, including in weekly urticaria activity score, weekly itch severity score and weekly hive severity score.

The data assessed at week 52 also demonstrated responses as early as the first week in patients who were receiving placebo and transitioned to remibrutinib at week 24, with responses sustained until the end of the study.

The number of deaths from non-melanoma skin cancer (NMSC) deaths are expected to surpass those from melanoma in England and Scotland for the first time, new research has shown.

Approximately 250,000 new cases of NMSC are diagnosed every year in the UK and, despite usually having a high survival rate in comparison to melanoma, the number of NMSC deaths are “on track” to overtake those from melanoma due to the significant number of people affected, the British Association of Dermatologists said.

Dermatology researchers looked at data from six countries with more than 1,000 skin cancer deaths annually, including England and Scotland, and found that deaths from melanoma reduced or remained static between 2010 and 2019 due to advances in care.  Meanwhile, NMSC deaths increased in the same period.

In England, the amount of deaths attributed to NMSCs increased by 42% over the past decade, which is higher than for many other cancers. If this trend continues, NMSC deaths are predicted to overtake melanoma in the countries studied, first in Scotland in 2028, then in the US in 2031 and England in 2038.

Equillium has announced positive top-line results from a phase 2 study of its multi-cytokine inhibitor EQ101 in adults with moderate, severe or very severe alopecia areata.

The mid-stage trial has been evaluating the candidate in more than 30 patients aged between 18 and 60 years with at least 35% scalp hair loss and a current hair loss episode of at least six months, but not more than seven years.

Patients were dosed intravenously once weekly for 24 weeks with EQ101 and subsequently followed for an additional four.

Results demonstrated a favourable safety and tolerability profile with no serious adverse events, and improvements in SALT scores were above the published historically low placebo response rates.

Of the 25 patients who completed 24 weeks of treatment, 20% achieved a SALT score of 20 or less by week 24. This increased to 29% for those with moderate-to-severe cases.

EQ101 has a targeted mechanism of action against cytokines IL-2, IL-9 and IL-15, which are key drivers of the pathogenic T cells implicated in the condition. Equillium now ends to evaluate a subcutaneous formulation of the candidate in placebo-controlled studies.