Almirall has entered into an exclusive licence agreement with Novo Nordisk to gain rights to develop its IL-21-blocking monoclonal antibody for immune inflammatory dermatological diseases.

Novo’s NN-8828 is a high-affinity monoclonal antibody that targets the cytokine IL-21, which has been developed up to phase 2 in non-dermatological indications.

NN-8828 has the potential to block the activation of the downstream signalling pathways of IL-21 and inhibit the pathophysiological functions induced by cytokines in several immune cells, therefore making the asset a promising option to treat inflammatory and autoimmune skin disorders.

Autoimmune skin diseases, including dermatitis herpetiformis and Sjögren’s syndrome, occur when the body’s immune system attacks healthy skin or tissue.

Under the terms of the agreement, Almirall will obtain global rights to develop and commercialise NN-8828 as a first-in-class agent in dermatology.

The company will accelerate the development of the asset to address key dermatological diseases while taking responsibility for the global development and future commercialisation in these fields.

Novo will receive an upfront payment from Almirall, along with additional development and commercial milestone payments, plus tiered royalties.

Pfizer’s Litfulo (ritlecitinib) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat severe alopecia areata in patients aged 12 years and older.

NICE’s decision, which could benefit up to 14,000 patients, makes Litfulo the first treatment for severe alopecia areata to be recommended by the agency for use on the NHS.

Litfulo works by blocking the activity of enzymes in the body involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

NICE’s decision on the drug follows an approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023 for the same patient population.

The MHRA’s decision was supported by positive results from the phase 2b/3 ALLEGRO trial, which evaluated Litfulo in patients aged 12 years and older with 50% or more scalp hair loss, including those with total scalp and body hair loss.

Results showed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo 50mg, compared to 1.5% in the placebo group.

Medicxi has announced the launch of Alys Pharmaceuticals, merging six of its dermatology-focused companies to develop novel therapies in immunodermatology with $100m in seed funding.

The new US- and Swiss-based biotech aims to reach its goal of delivering seven to ten proof-of-concept readouts by the end of 2026.

The new drugmaker was co-founded by Medicxi as well as several dermatology and scientific experts from around the world, including UMass Chan Medical School’s Craig Mello.

All founders, which also include experts from the Icahn School of Medicine at Mount Sinai, Ludwig Maximilian University, the Institut Gustave Roussy and the Georgia Institute of Technology, have minority stakes in Alys.

The company brings together Aldena Therapeutics, Graegis Pharmaceuticals, Granular Therapeutics, Klirna Biotech, Nira Biosciences and Vimela Therapeutics, which operate in therapeutic areas including psoriasis, atopic dermatitis, pruritus, vitiligo and some forms of skin cancer.

As part of the deal, each subsidiary company’s main asset will be developed largely autonomously by the existing team to develop new medicines that address patients who do not have access to therapeutics, such as for common indications like atopic dermatitis.

Johnson & Johnson (J&J) and Protagonist Therapeutics’ investigational targeted oral peptide that selectively blocks the IL-23 receptor has shown promise as a treatment for moderate-to-severe plaque psoriasis, according to phase 2b results published in the New England Journal of Medicine.

More than 125 million people worldwide are estimated to be living with plaque psoriasis, an immune-mediated disease resulting in the overproduction of skin cells.

IL-23 plays a vital role in the pathogenic T-cell activation of the condition and other immune-mediated inflammatory diseases.

Results from the phase 2b FRONTIER 1 trial showed that a greater proportion of patients who received JNJ-2113 achieved the trial’s primary endpoint of a Psoriasis Area and Severity Index (PASI) score of 75 compared to placebo at week 16, with 79% of patients receiving JNJ-2113 100mg twice-daily achieving PASI 75.

The data was consistent with the trial’s secondary endpoints, with 40.5% of patients who received the highest dose of JNJ-2113 achieving PASI 100 and 45.2% achieving IGA zero (clear skin).

Improvements were also observed across patient-reported outcomes, and rates of adverse events were generally similar between both groups.

Novartis has announced that the Scottish Medicines Consortium has approved Consentyx (secukinumab) to treat adults with active moderate-to-severe hidradenitis suppurativa (HS) in Scotland on the NHS.

Adult patients with active, moderate-to-severe HS who have responded inadequately to AbbVie’s Humira (adalimumab) will be eligible to receive the treatment.

Affecting approximately 2% of the Scottish population, HS is a painful, long-term skin condition that causes skin abscesses and scarring.

The SMC’s decision was based on results from two phase 3 trials, SUNSHINE and SUNRISE, which showed that treatment response rates in patients randomised to receive Consentyx improved beyond the primary endpoint analysis at week 16, with over 55% of patients achieving a HS clinical response at week 52.

In addition, a total of 50% of patients randomised to Consentyx had a reduction in HS-related pain at week 52.

Now the second biologic treatment option to receive positive SMC advice for the treatment of HS, Consentyx directly inhibits interleukin-17A, a key cytokine involved in the inflammation of psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, non-radiogrphic axial spondyloarthritis and HS.