Pharmaceutical Market Europe • June 2024 • 10-11

DERMATOLOGY NEWS

Researchers develop microneedle patch to reverse alopecia areata

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Researchers from the Massachusetts Institute of Technology, Brigham and Women’s Hospital, and Harvard Medical School have developed a new potential treatment to reverse hair loss caused by alopecia areata.

Published in Advanced Materials, the new microneedle patch delivers immune-regulating molecules to teach T cells to not attack hair follicles, leading to hair regrowth for patients of all ages.

Affecting more than six million people in the US, alopecia areata occurs when the body’s own T cells attack hair follicles, which leads to hair loss.

The newly developed microneedle patch is made from hyaluronic acid cross-linked with polyethylene glycol, which can be painlessly applied to the scalp and releases drugs that can help to rebalance the immune response at the site while also collecting samples to be used to monitor the progress of the treatment.

The team found that the patch helped hair regrow in a study of mice that were treated every other day for three weeks and significantly reduced inflammation at the treatment site while avoiding systemic immune effects in other areas of the body.


Companies in deal worth $1.25bn for atopic dermatitis treatment

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Johnson & Johnson (J&J) has entered into a definitive agreement with Numab Therapeutics to acquire its wholly-owned subsidiary, Yellow Jersey Therapeutics (YJT), in a deal worth $1.25bn.

As part of the deal, which is set to close in the second half of this year, J&J’s all-cash transaction to acquire YJT will provide the company with global rights to develop, manufacture and commercialise the subsidiary’s investigational, first-in-class bispecific antibody to treat atopic dermatitis (AD), NM26.

Estimated to affect more than 100 million people globally, AD is an inflammatory condition that causes the skin to become itchy, dry and cracked.

Approximately 70% of patients with the heterogeneous disease being treated with current therapies do not achieve remission.

Currently ready to enter phase 2 studies, NM26 targets two clinically proven pathways: the IL-4R alpha subunit, which triggers Th2-mediated skin inflammation in AD and IL-31, which impacts skin itch and subsequent scratching that worsens the disease.

In addition, the investigational bispecific antibody holds the potential to be efficacious in other inflammatory skin diseases involving Th2 inflammation and itch.


Moderna/Merck share positive three-year results for skin cancer vaccine

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Moderna and Merck & Co – known as MSD outside the US and Canada – have shared promising three-year data for their investigational skin cancer vaccine mRNA-4157 (V940).

The phase 2b KEYNOTE-942/mRNA-4157-P201 study has been evaluating the candidate in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in 157 patients with high-risk stage 3 or 4 melanoma, following complete resection.

The incidence of melanoma has been rising over the past few decades, with more than 330,000 new cases diagnosed globally in 2022.

The results presented at this year’s American Society of Clinical Oncology Annual Meeting showed that after a median follow-up of 34.9 months, adjuvant treatment with mRNA-4157 plus Keytruda continued to demonstrate a clinically meaningful and durable improvement in the trial’s primary endpoint of recurrence-free survival, reducing the risk of recurrence or death by 49% compared to Keytruda alone.

The mRNA-4157/Keytruda combination also continued to demonstrate a meaningful improvement in distant metastasis-free survival, a key secondary endpoint of the study, compared to Keytruda alone, reducing the risk of developing distant metastasis or death by 62%.


LEO Pharma shares results for plaque psoriasis treatment

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LEO Pharma has shared positive results from a late-stage trial of Enstilar (LEO 90100) in adults with stable plaque psoriasis.

Up to 90% of psoriasis patients have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales.

LEO outlined that Enstilar, an aerosol spray foam containing calcipotriol monohydrate and betamethasone dipropionate, is an “improved formulation” of its Daivobet ointment, a current standard treatment option for plaque psoriasis.

Enstilar is already authorised in the EU to treat psoriasis vulgaris in adults for up to four weeks and as a long-term maintenance treatment for those who have responded to the initial treatment. The therapy also holds approvals in other markets worldwide.

The phase 3 trial has been comparing the efficacy and safety of a once-daily application of Enstilar against Daivobet ointment for four weeks in more than 600 stable plaque psoriasis patients across China.

Enstilar was superior to Daivobet in the primary endpoint, demonstrating improved efficacy in reducing the severity and extent of stable plaque psoriasis.

Both treatments were well tolerated and their safety profiles were consistent with previous trial findings.


J&J expands dermatology portfolio with $850m Proteologix acquisition

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Johnson & Johnson (J&J) has announced that it will be acquiring Proteologix in a deal worth $850m, as well as gaining access to its atopic dermatitis (AD) treatments.

Expected to close mid-year 2024, the acquisition will expand J&J’s dermatology portfolio, while addressing significant unmet needs in AD.

Under the terms of the agreement, J&J will pay a cash payment of $850m, with the potential for additional milestone payments, and will gain access to the biotechnology company’s two AD treatments, PX128 and PX130.

In addition, the acquisition will provide J&J with other bispecific antibody programmes with applications across a variety of other diseases.

Ready to enter phase 1 development for AD and asthma, PX128 is a bispecific antibody that targets IL-13 type 2 cell-mediated skin inflammation – an important driver of disease in AD and asthma – plus thymic stromal lymphoietin, an epithelial cell-derived cytokine that mediates tissue inflammation in both conditions.

Currently in preclinical development, PX130 is a bispecific antibody that targets IL-13 and IL-22, which works to restore the skin barrier and prevent inflammation from environmental triggers such as allergens.


Almirall survey reveals limited knowledge of precancerous skin condition

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Almirall has published the results of a survey that revealed that more than one-third of people who have suffered from actinic keratosis (AK), the most common precancerous skin condition, are unaware of what causes it.

Closely related to overexposure to sunlight over time, AK is one of the most common diagnoses made by dermatologists, with an estimated prevalence of 13.3% in the European population.

Approximately 60% of squamous cell carcinoma, the second most common form of skin cancer, develops from AK lesions.

Almirall’s survey, which included more than 2,500 participants aged over 35 years, aimed to establish the relationship between the disease and prolonged exposure to sunlight as part of its AK Global Day ‘Stay Vigilant’ campaign launched on 24 May.

The survey revealed that nearly 60% of people had never had their skin checked by a professional and that half of Europe’s population gets sunburned at least once a year.

This figure increased significantly among people aged between 25 and 44 years, with more than six out of ten people getting sunburned at least once a year.