Pharmaceutical Market Europe • June 2023 • 10-11

DERMATOLOGY NEWS

Eli Lilly and Almirall’s lebrikizumab results in atopic dermatitis

Image

Eli Lilly and Almirall’s lebrikizumab has been associated with stable and long-lasting improvements in atopic dermatitis, according to new secondary data from the phase 3 trials investigating the drug.

The identically designed ADvocate1 and ADvocate2 trials evaluated the efficacy and safety of lebrikizumab as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis versus placebo.

A post hoc analysis based on data from the two studies’ 16-week induction periods in addition to the 16-week ADhere study, which evaluated the drug in combination with topical corticosteroids, showed that up 73% of patients treated with lebrikizumab experienced improvement or clearance of face or hand dermatitis.

Additionally, 80% of patients treated with lebrikizumab in ADvocate 1 and 2 maintained an improvement of at least 75% in lesion extent and severity (EASI-75) at 52 weeks after achieving EASI-75 at 16 weeks.

More than 70% maintained EASI-75 response with no or minimal fluctuations across ten study visits through 52 weeks of treatment, the companies said.

Almirall has licensed the rights to develop and commercialise lebrikizumab for use as a treatment of dermatology indications in Europe, while Lilly has exclusive rights for the development and commercialisation of lebrikizumab in the US and the rest of the world.


Positive results for Sanofi/Regeneron’s Dupixent in prurigo nodularis

Image

Sanofi and Regeneron’s Dupixent (dupilumab) was associated with significant improvements in uncontrolled prurigo nodularis symptoms, according to positive phase 3 results recently published in Nature Medicine.

Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is, as reported by the companies, one of the highest among inflammatory skin diseases due to the extreme itch it causes.

High-potency topical steroids commonly prescribed for the treatment of the disease are associated with safety risks if used long term, underscoring the need for new treatment options.

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central to the type 2 inflammation that plays a major role in multiple related and often comorbid diseases.

The two phase 3 studies, PRIME and PRIME2, met their shared primary endpoint of a clinically meaningful improvement in itch from baseline at 24 and 12 weeks, respectively.

Statistically significant results were also seen across additional endpoints, including the proportion of patients with clear or almost clear skin of nodules at 24 weeks, and improvement from baseline in health-related quality of life, skin pain and symptoms of anxiety and depression.


BMS’s Sotyktu approved by MHRA for plaque psoriasis

Image

Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib) has been authorised for use in Great Britain to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The decision from the Medicines and Healthcare products Regulatory Agency (MHRA) was supported by positive results from two phase 3 trials, in which once-daily Sotyktu was associated with superior improvements in skin clearance, symptom burden and quality of life measures compared to both placebo and twice-daily Otezla (apremilast).

It is estimated that up to 1.8 million people in the UK are affected by some form of psoriasis, a life-long inflammatory condition that typically affects the skin, nails and joints.

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

Despite the availability of effective systemic therapies, BMS reports that many patients with moderate-to-severe psoriasis remain under-treated, untreated or dissatisfied with current treatment options.

Sotyktu is already approved in major markets, including in the US and Japan. The therapy was also approved by the European Commission at the end of March this year for moderate-to-severe plaque psoriasis, following a recommendation from the Committee for Medicinal Products for Human Use.


Incyte’s Opzelura cream receives EC approval for non-segmental vitiligo

Image

Incyte’s Opzelura (ruxolitinib) cream has been approved by the European Commission (EC) to treat adults and adolescent patients aged 12 years and older with non-segmental vitiligo with facial involvement.

The EC’s decision makes the JAK inhibitor the first and only approved treatment in the EU to target re-pigmentation in this patient population.

The company’s application was supported by data from two phase 3 clinical trials – TRuE-V1 and TRuE-V2 – evaluating the safety and efficacy of Opzelura versus vehicle in more than 600 non-segmental vitiligo patients.

Opzelura was associated with significant improvements in facial and total body re-pigmentation versus vehicle, as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI) endpoints at week 24 and in an open-label extension at week 52.

Results at week 24, which were consistent across both studies, showed that 29.8% and 30.9% of Opzelura-treated patients achieved at least a 75% improvement from baseline in the F-VASI, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively.

Additionally, at week 24, more than 15% of patients treated with Opzelura achieved at least a 90% improvement from baseline in F-VASI, compared to approximately 2% of patients treated with vehicle.


Almirall and CRG announce non-melanoma skin cancer research collaboration

Image

Almirall SA and biomedical research institute, the Centre for Genomic Regulation (CRG), have announced a collaboration aimed at developing and distinguishing novel preclinical models to identify new treatments for non-melanoma skin cancer (NMSC).

NMSC belongs to a group of cancers that develop in the upper layers of the skin. Non-melanoma specifies more common kinds of skin cancer from the less common kind known as melanoma.

The two most common types of NMSC are squamous cell carcinoma and basal cell carcinoma, representing 70% and 25% of NMSC cases, respectively.

Through the new partnership, Almirall investigators and CRG’s team of researchers will merge their knowledge to inaugurate experimental models that allow identification, as well as validation of new therapeutic approaches and the evaluation of new drugs for these diseases.

The research partnership comes after AlmirallShare – the company’s open innovation platform for discovering innovative therapies for skin diseases – made a call for proposals. Formed in 2017, AlmirallShare was created to make dermatological research collaborations easier and accelerate the development of skin condition treatments.

The collaboration between Almirall and CRG represents another milestone in this endeavour, Almirall said, and builds on the eight established partnerships based on models, targets and new therapies for dermatological diseases, including hidradenitis suppurativa.


Dermavant’s Vtama cream results in atopic dermatitis trial

Image

Dermavant Sciences has reported positive results from a phase 3 trial of its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children aged as young as two years with moderate-to-severe atopic dermatitis.

More commonly referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone and up to 30% of children worldwide.

The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, face and neck.

Dermavant’s ADORING 1 trial met its primary endpoint, with 45.4% of Vtama-treated patients experiencing improvements in an investigator assessment of lesions. This is compared to 13.9% of patients who received vehicle cream.

Benefits were also seen across key secondary endpoints, including 55.8% of patients experiencing improvements on the EASI test, which is used to measure the extent and severity of the condition, versus 22.9% in the vehicle cohort.

Additionally, 55.8% of patients aged 12 years and older saw a reduction in itching, compared to 34.2% receiving vehicle.

This latest data supports positive results from the identically designed ADORING 2 trial, which were released by the company in March.