Pharmaceutical Market Europe • April 2024 • 10-11
DERMATOLOGY NEWS
Sanofi has announced positive results from a phase 2b study of its amlitelimab, which the company says “support the potential for best-in-class maintenance of response” in moderate-to-severe atopic dermatitis.
Results from the STREAM-AD study were recently presented as part of a late-breaking session at the American Academy of Dermatology 2024 Conference.
The randomised, double-blind placebo-controlled study evaluated amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled with topical therapies or where these were not advisable.
The study showed sustained improvements in signs and symptoms for 28 weeks in patients who previously responded to amlitelimab and continued treatment.
In the second phase of the trial, patients who previously achieved a 75% improvement in eczema area and severity index score (EASI) and/or investigator global assessment (IGA) score of zero or one during the 24-week period were randomised to continued amlitelimab treatment or withdrawal for 28 weeks.
In approximately 69.2% of patients who continued treatment with amlitelimab 250mg with 500mg loading doses versus 58.8% of patients withdrawn from treatment, IGA zero to one and/or EASI-75 response were maintained.
Johnson & Johnson (J&J) and Protagonist Therapeutics’ JNJ-2113 has been shown to maintain skin clearance in patients with moderate-to-severe plaque psoriasis, according to long-term results presented at the American Academy of Dermatology Annual Meeting.
JNJ-2113 is the first targeted oral peptide designed to block the IL-23 receptor, which underpins the inflammatory response in the condition.
Results from the phase 2b FRONTIER 1 trial recently published in the New England Journal of Medicine showed that a greater proportion of patients who received JNJ-2113 achieved the primary endpoint of a Psoriasis Area and Severity Index (PASI) score of 75 compared to placebo at week 16.
New data from FRONTIER 2, the long-term extension of FRONTIER 1, has shown that the candidate maintained high rates of skin clearance through 52 weeks.
In the five JNJ-2113 treatment groups, response rates were maintained from week 16 to week 52, with the highest PASI 75 response observed in the 100mg twice-daily group.
Key secondary endpoints of PASI 90 and PASI 100, as well as Investigator’s Global Assessment scores, were also maintained through week 52 for all five treatment groups.
Eli Lilly has shared positive phase 3 results for lebrikizumab to treat moderate-to-severe atopic dermatitis across a range of skin tones.
Recently presented at the American Academy of Dermatology Annual Meeting, the ADmirable study evaluated lebrikizumab in 50 patients with moderate-to-severe atopic dermatitis and darker skin tones, including individuals of Black or African American, Asian, American Indian or Alaska Native descent, as measured by the Fitzpatrick scale.
The results at 16 weeks showed a significant improvement of at least 75% in disease extent and severity in 68% (EASI-75) of patients and at least EASI-90 in 46% of patients, while 39% of patients achieved clear or almost clear skin with a reduction of at least two points from baseline and 56% experienced clinically meaningful itch relief.
Using the newly developed PDCA-Derm scale, the study also included a physician assessment of changes in post-inflammatory pigmentations.
Lebrikizumab is licensed to be developed and commercialised as a treatment for dermatology indications in Europe by Almirall, while Eli Lilly has exclusive rights for the drug in the US and the rest of the world.
UCB’s Bimzelx (bimekizumab) has been recommended by the European Medicines Agency’s human medicines committee to treat active moderate-to-severe hidradenitis suppurativa (HS).
Estimated to affect about 1% of the population in most studied countries, HS is an inflammatory skin disease that causes nodules, abscesses and pus-discharging draining tunnels. Many patients experience flare-ups of the disease as well as severe pain.
UCB’s bimekizumab is designed to selectively inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.
The recommendation from the Committee for Medicinal Products for Human Use, which specifically applies to adults who have had an inadequate response to conventional systemic therapy, was supported by positive data from the phase 3 BE HEARD I and BE HEARD II studies.
Results showed that Bimzelx was associated with statistically significant and clinically meaningful improvements over placebo in the signs and symptoms of adults with moderate-to-severe HS as measured by HiSCR50 at week 16, with responses maintained to week 48.
Treatment with Bimzelx also resulted in improvements over placebo in the high threshold endpoint, HiSCR75 at week 16, with these responses sustained to week 48.
Dermavant Sciences has shared positive late-stage results for its Vtama (tapinarof) cream in adults and children as young as two years old with atopic dermatitis.
The condition affects up to 10% of adults and 20% of children worldwide.
According to results from the identically designed vehicle-controlled ADORING 1 and ADORING 2 trials presented at the American Academy of Dermatology Annual Meeting, Vtama cream demonstrated statistically significant efficacy in adults and children with atopic dermatitis across a range of skin tones.
In ADORING 1 and ADORING 2, 47% and 43.1% of Black or African American patients, respectively, achieved the shared primary endpoint of a Validated Investigator Global Assessment for Atopic Dermatitis score of zero (clear) or one (almost clear) and at least a two-grade improvement from baseline at week eight.
This was achieved by 39.5% and 48.9% of Asian patients and 49.4% and 52.1% of white patients in ADORING 1 and ADORING 2, respectively.
Benefits were also seen across key secondary endpoints, including 75% or more improvement on the EASI test, which is used to measure the extent and severity of the condition.
Almirall and Eloxx Pharmaceuticals have entered into an exclusive agreement to license the phase 1-ready asset ZKN-013 for rare dermatological diseases, with the deal worth more than $470m.
ZKN-013 is designed to overcome nonsense mutations that cause a premature stop codon, resulting in non-functional protein production.
This occurs in rare skin diseases such as recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa.
Under the terms of the agreement, Eloxx will receive $3m and additional payments from Almirall throughout the potential development phases, including regulatory and sales milestones of up to $470m, as well as tiered royalties.
In exchange, Almirall will gain global rights to develop and commercialise ZKN-013 for the treatment of rare dermatological and other diseases associated with nonsense mutations.
ZKN-013 is Eloxx’s lead asset designed through its TURBO-ZM platform, which uses chemistry technology to develop novel ribosome modulating agents to target the human ribosome to develop new potential therapeutics.
The agreement came less than one month after Almirall entered into an exclusive licence agreement with Novo Nordisk to gain rights to its IL-21-blocking monoclonal antibody for immune inflammatory dermatological diseases.