Pharmaceutical Market Europe • January 2024 • 10-11
DERMATOLOGY NEWS
Bristol Myers Squibb’s (BMS) Opdualag (nivolumab and relatlimab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat patients aged 12 years and older with advanced melanoma.
The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with around 17,000 cases of the disease diagnosed in the UK every year.
The active ingredients in Opdualag, which is administered via a drip over 30 minutes every four weeks, are designed to recognise and attach to a specific target substance in the body, helping patients’ immune systems to fight cancer.
The MHRA’s decision on the therapy was supported by results from a phase 2/3 clinical trial of 714 patients with previously untreated advanced melanoma who were randomised to receive a combination of nivolumab and relatlimab or nivolumab alone.
The combination was shown to have more than doubled median progression-free survival compared to nivolumab alone at a median follow-up of 19.3 months.
The regulatory agency authorised Opdualag through Project Orbis, a global partnership between regulatory bodies to review and approve promising cancer drugs, to help patients access treatments more quickly.
Almirall has announced a new multi-target alliance with etherna to discover and develop new mRNA-based therapies to treat dermatological diseases.
The alliance will combine mRNA and lipid nanoparticle (LNP) technology to accelerate the discovery of new treatments for severe skin diseases, including non-melanoma skin cancer.
The companies will utilise etherna’s proprietary mRNA capabilities and LNP formulations with Almirall’s expertise in medical dermatology.
Both will work together on research activities, while Almirall will be responsible for leading clinical development and commercialisation.
The mRNA/LNP technology platform company’s delivery of LNP-formulated mRNA for transient and local translation of therapeutic proteins works to encode multiple therapeutically active components within a single treatment.
“Intradermal application of LNP-formulated mRNA is a highly promising strategy to bring novel, efficacious new treatment options that will deliver huge benefits to patients,” explained Bernard Sagaert, chief executive officer of etherna.
Under the terms of the agreement, etherna will receive an upfront and technology access payment from Almirall, as well as up to €300m in success-based development and commercial milestone payments contingent upon the launch and commercial success of several products.
In addition to this, etherna will also be eligible to receive tiered royalties based upon future global sales.
Dermavant Sciences has reported positive results from a phase 4 trial of its plaque psoriasis-approved Vtama (tapinarof) cream 1% in plaque psoriasis affecting the head and neck region.
Approximately 125 million people worldwide are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.
Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back.
The open-label DMVT-505-4002 study enrolled 31 adults with mild, moderate and severe head and neck plaque psoriasis at eight sites across the US.
Results showed that 88.5% of patients achieved a target lesion Physician Global Assessment (tPGA) success score of zero (clear) or one (almost clear) and a two-point or greater improvement in tPGA score from baseline at week 12, meeting the study’s primary endpoint.
The secondary endpoint of the study was also met, Dermavant said, with tPGA success achieved as early as week one in some patients and at a median time of approximately four weeks.
Journey Medical has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for DFD-29 (minocycline hydrochloride modified release capsule) to treat inflammatory lesions and erythema (redness) of rosacea in adults.
Affecting approximately 16 million people in the US, rosacea is a long-term, inflammatory skin condition that causes small, red, pus-filled bumps, redness and visible blood vessels in the face.
If approved by the FDA, DFD-29, which is being developed in collaboration with Dr Reddy’s Laboratories, has the potential to become the only oral, systemic therapy approved to address both erythema and inflammatory lesions associated with the condition.
The NDA is supported by two late-stage clinical trials, which achieved all co-primary and secondary endpoints and demonstrated no significant safety issues associated with DFD-29, with all patients completing the 16-week treatment.
In patients with rosacea, DFD-29 demonstrated statistical superiority over both the current standard-of-care treatment, Oracea (doxycycline) 40mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as reduction in the total inflammatory lesion count.
On a secondary endpoint related to erythema assessment, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment compared to placebo.
Almirall, the Barcelona Supercomputing Center-Centro Nacional de Supercomputión (BSC-CNS) and Nostrum Biodiscovery have announced a new partnership aimed at finding new therapies for dermatological diseases.
The collaboration, ARTIBAND, will explore artificial intelligence (AI) and machine learning (ML) approaches to design new protein-protein modulators for new therapies.
AI in the pharmaceutical sector has great potential, especially in areas of generative chemical modelling.
By training platforms using chemical data to develop generative algorithms for chemical modelling, these AI and ML platforms can propose new chemical materials based on the learned language model, proposing compounds that are different and better-suited to those found in compound libraries.
Over the next three years, the technology will be developed and trained with data from the public domain and, as part of a second phase, the technology will be further optimised and applied to the discovery of new protein-protein modulators of Almirall’s interest.
The Spanish Ministry of Science and Innovation funded the project as part of the EU-funded Recovery, Transformation and Resilience Plan.
The project builds on the current-standing partnership between Almirall and BSC, which have been collaborating since 2018 in the research programme SilcoDerm for computational drug design for dermatological therapeutic targets.
AbbVie has announced positive results from a mid-stage trial of lutikizumab in adults with moderate-to-severe hidradenitis suppurativa (HS) who have previously failed anti-TNF therapy.
HS is a chronic, inflammatory skin disease that causes painful bumps, nodules or abscesses that can leak fluid and lead to scarring.
An estimated 1% of the global population is affected by HS, but patients can experience increasing disease severity and symptoms for as long as ten years before receiving a diagnosis.
Among those enrolled in the 16-week phase 2 trial, 70.6% had the most extensive form of the condition, characterised by scarring, lesions and sinus tracts.
Results showed that patients treated with lutikizumab 300mg every other week or 300mg weekly achieved response rates of 59.5% and 48.7%, respectively, compared to 35% in the placebo cohort, meeting the trial’s primary endpoint of achieving HS Clinical Response (HiSCR 50) at week 16.
Higher response rates were also observed in patients receiving lutikizumab 300mg every other week or 300mg weekly than those treated with placebo in the secondary endpoint of skin pain NRS30 at week 16 among patients with a baseline NRS score of three or greater.
The company said it will now advance lutikizumab in HS to phase 3 following the positive results.