Pharmaceutical Market Europe • April 2025 • 10-11
DERMATOLOGY NEWS
Novartis will be gaining global rights to Kyorin Pharmaceutical’s preclinical inflammatory disease drug in a deal worth more than $830m.
The agreement provides Novartis with an exclusive worldwide licence to develop, manufacture and commercialise KRP-M223, an MRGPRX2 antagonist for chronic spontaneous urticaria, as well as other allergic and inflammatory diseases that involve mast cells.
Approximately 40 million people globally are affected by chronic spontaneous urticaria, a common skin condition characterised by the sudden appearance of raised, itchy and sometimes painful hives (wheals) that last for at least six weeks.
Alongside its physical symptoms, chronic spontaneous urticaria can significantly impact well-being, with many patients experiencing sleep deprivation, as well as psychiatric disorders such as anxiety and depression.
Under the terms of the agreement, Kyorin will receive an upfront payment of $55m from Novartis and will be eligible for milestone payments of up to $777.5m, as well as tiered royalties on net sales. Kyorin will also have the option to commercialise KRP-M223 in Japan, with Novartis retaining its own option to co-promote the product in this market.
Johnson & Johnson (J&J) and Protagonist Therapeutics have announced new data from a late-stage programme of their investigational targeted oral peptide in plaque psoriasis.
Results from the phase 3 ICONIC-LEAD study presented at this year’s American Academy of Dermatology annual meeting showed that icotrokinra (JNJ-2113) was associated with significant skin clearance in adults and adolescents aged 12 years and older with moderate-to-severe cases of the skin disease.
More than 125 million people worldwide are estimated to be living with plaque psoriasis, which causes inflamed, scaly plaques. These can occur anywhere on the body and may be itchy or painful.
In ICONIC-LEAD, 65% of patients receiving once-daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of zero or one (clear or almost clear skin) and 50% achieved at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90), compared to 8% and 4% of those randomised to receive placebo, respectively, at week 16.
Continued skin clearance improvement was also reported at week 24, with 74% of icotrokinra-treated patients achieving an IGA score of zero or one and 65% reaching PASI 90.
The 16th Skin Academy conference, held on 22-23 March in Barcelona, Spain by Almirall, highlighted collaboration and the development of new methods and solutions in the field of dermatology.
The event brought together a broad range of experts and clinicians from across the world, with this year’s offering featuring a programme aimed at sharing scientific knowledge on skin diseases, their treatment and clinical best practice.
Among the diseases covered in this year’s programme was actinic keratosis (AK), the most common precancerous skin condition, characterised by rough, scaly patches of skin that commonly develop on the most exposed areas of the body.
The Skin Academy conference highlighted the importance of early treatment in AK to prevent its progression to squamous cell carcinoma, with experts focusing on advancements in treatment, real-world evidence and the importance of patient satisfaction in treatment outcomes.
Psoriasis, an immune-mediated disease that causes inflammation in the body, was another key focus at this year’s event, with sessions dedicated to biologic treatments.
Topics on other dermatological conditions, including atopic dermatitis, androgenetic alopecia, onychomycosis and chronic spontaneous urticaria, were also included in the programme.
Amgen and Kyowa Kirin have shared promising results from a phase 3 programme of their investigational T-cell rebalancing therapy rocatinlimab in atopic dermatitis (AD).
The 24-week IGNITE study, which met its co-primary endpoints and all key secondary endpoints, evaluated two doses of the candidate in more than 760 adults with moderate-to-severe AD, including those previously treated with a biologic or systemic Janus kinase inhibitor medication.
At the end of the trial, 42.3% of patients receiving the higher dose of rocatinlimab achieved at least a 75% reduction from baseline in their Eczema Area and Severity Index score (EASI-75), representing a 29.5% difference against placebo. In the lower dose group, 36.3% of rocatinlimab-treated patients achieved EASI-75, a 23.4% difference versus placebo.
Additionally, 23.6% of patients being treated with higher dose rocatinlimab and 19.1% of those in the lower dose group achieved a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of zero or one (clear or almost clear skin) with at least a two-point reduction from baseline at week 24, representing a 14.9% and 10.3% difference versus placebo, respectively.
Organon has shared positive results from a long-term extension (LTE) study of its Vtama (tapinarof) cream, 1% in atopic dermatitis (AD) patients aged as young as two years.
Findings from the phase 3 48-week ADORING 3 trial, presented at this year’s American Academy of Dermatology annual meeting, showed that disease activity remained mild in patients who achieved treatment success with the non-steroidal topical therapy.
Patients who entered ADORING 3 with completely clear skin or achieved this during the LTE, defined as a validated Investigator Global Assessment for AD (vIGA-AD) score of zero, stopped using Vtama and were assessed for maintenance of vIGA-AD scores of zero (clear) or one (almost clear) off-treatment. Those whose AD returned to a vIGA-AD score of two or higher (mild or above) were retreated until complete disease clearance was achieved again or until the study was completed.
At the end of the first treatment-free interval, which lasted for an average of 79.8 consecutive days, 84% of patients had a vIGA-AD score of two. Additionally, itch remained low and the mean Eczema Area and Severity Index score indicated mild disease.
Eli Lilly and Incyte have shared positive results from a late-stage study of baricitinib in adolescents with severe alopecia areata.
Results from the phase 3 BRAVE-AA-PEDS trial, presented at this year’s American Academy of Dermatology annual meeting, showed that patients aged 12 to 17 years treated with once-daily, oral baricitinib 4mg and 2mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes.
At week 36 of the study, 60% of patients receiving baricitinib 4mg and 36.9% of those being treated with baricitinib 2mg saw at least a 50% improvement in their disease, as measured by Severity of Alopecia Tool (SALT) score, compared to 5.7% on placebo.
Additionally, 42.4% and 27.4% of patients receiving baricitinib 4mg and 2mg, respectively, achieved 80% or more scalp hair coverage, compared to 4.5% of those in the placebo group, while 36.5% of patients receiving baricitinib 4mg and 21.4% of those receiving baricitinib 2mg had 90% or more scalp hair coverage, compared to 2.3% on placebo.
Baricitinib also led to significant eyebrow and eyelash growth compared to placebo.