Delving into the Latest Updates on Bimekizumab with Synapse

Psoriasis is a chronic inflammatory condition driven by a complex interplay between heritable and microenvironmental factors. Genome-wide heritability for psoriasis (PsO) is estimated at up to 50%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.
Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 weeks until complete clearance of the lesion. After a maximum of 4 weeks topical clobetasol will be applied twice weekly on the site of lesion until week 16 then stopped. Patients will not receive active treatment between week 16-24. Between week 24-96 patients that flare can receive continuous topical clobetasol if needed. These patients will be considered non-responders at subsequent timepoints for the main analysis. If the patients worsen their psoriasis under the treatments given during the study and progress to moderate or severe psoriasis (PASI 10 and above) they will end their participation to the study to receive a treatment adapted to the new severity of their psoriasis. The patients will be referred to their dermatologist to receive the actual standard of care adapted to their new condition.
During the study, the following assessments will be performed and samples will be collected

Start Date01 Jun 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nice

NCT06888193

/ Not yet recruitingPhase 1

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.

Start Date16 May 2025

Sponsor / Collaborator

UCB Biopharma SRL

NCT06921850

/ RecruitingPhase 3

A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa

The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)

Start Date07 Apr 2025

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Bimekizumab

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100 Translational Medicine associated with Bimekizumab

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100 Patents (Medical) associated with Bimekizumab

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304

Literatures (Medical) associated with Bimekizumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Bimekizumab for the treatment of moderate to severe psoriasis: a real-world experience over 52 weeks from two Italian dermatology clinics

Article

Author: Loconsole, F. ; Bianchi, L. ; Gaeta Shumak, R. ; Mortato, E. ; Campione, E. ; Rivieccio, Antonia ; Lanna, C. ; Borselli, C. ; Artosi, F. ; Lambiase, S. ; Compagnucci, I.

PURPOSE:

Psoriasis is a chronic, immune-mediated inflammatory skin condition marked by erythematous, scaly plaques. This retrospective observational study evaluated the long-term efficacy and safety of bimekizumab, a dual IL-17A and IL-17F inhibitor, in treating moderate to severe plaque psoriasis in 56 patients across two dermatology clinics in Italy.

MATERIALS AND METHODS:

Adult participants with a baseline Psoriasis Area and Severity Index (PASI) >10, or <10 with sensitive area involvement, were followed for 16 to 52 weeks. Clinical outcomes were measured by PASI 75, 90, and 100 responses and Dermatology Life Quality Index (DLQI) scores at 4, 16, 36, and 52 weeks.

RESULTS:

At week 16, 97.5% of patients achieved PASI 75, 76.7% reached PASI 90, and 66% attained PASI 100. By week 52, 91.5% achieved PASI 90 and 85.1% reached PASI 100, with 95.7% reporting a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating minimal impact on daily life. The study found similar efficacy across bio-naïve and bio-experienced groups, and between normal-weight and obese patients, without statistically significant differences. The safety profile was consistent with previous trials, with oral candidiasis as the most frequent adverse event (21%).

CONCLUSIONS:

These findings support the efficacy and tolerability of bimekizumab for long-term psoriasis management.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Bimekizumab as-needed dosing in patients with psoriasis: a case series

Article

Author: Blauvelt, Andrew ; Berna-Rico, Emilio ; Jaén, Pedro ; González-Cantero, Álvaro ; Abbad-Jaime De Aragón, Carlota

INTRODUCTION:

Despite significant advances in psoriasis treatment, off-label dosing studies of psoriasis biologic therapies are limited.

MATERIALS AND METHODS:

In this retrospective case series, medical records from 28 patients with moderate-to-severe psoriasis treated with bimekizumab during 64-week period from May 2023 to October 2024 at the Psoriasis Unit of the Grupo Jaen (Madrid, Spain), were evaluated. Patients were managed with an off-label, as-needed, dosing strategy, with all patients initially receiving two 320 mg doses of bimekizumab at Weeks 0 and 4; subsequent doses were administered only if a given patient dropped below a PASI90 response. Primary outcome was the percentage of patients that achieved and maintained optimal skin control over time, defined as achieving a PASI90 response.

RESULTS:

Twenty-seven out of the 28 patients achieved a PASI90 response after the first two bimekizumab doses, and all maintained PASI90 responses with as-needed dosing over time. One patient achieved PASI90 after a single dose of bimekizumab, and voluntarily decided not to receive a second dose. No adverse events were observed.

CONCLUSIONS:

Larger prospective studies comparing efficacy and safety of this off-label, as needed, bimekizumab dosing regimen with standard on-label dosing are necessary to corroborate these findings.

01 Jun 2025·JAAD international

Adverse events associated with bimekizumab for moderate-to-severe plaque psoriasis: A retrospective, multicenter, post-hoc analysis

Article

Author: Hashemi, Kimberly ; Vazquez-Machado, Maria ; LaChance, Avery H ; Loranger, Nicole ; Elshaboury, Soha ; Zangenah, Nikki

127

News (Medical) associated with Bimekizumab

25 Mar 2025

·endpts.com

Another immunology biotech emerges as Hillstar takes flight with $67M

The flurry of immunology biotech launches continues. Boston-based Hillstar Bio on Tuesday became the latest immunology startup launch, unveiling a $67 million Series A round funded by Droia Ventures, Frazier Life Sciences, Novo Holdings and LifeArc Ventures. The biologics developer has been in the works since 2023, CEO Robert Mabry told Endpoints News . Mabry joined Hillstar in recent months after departing his chief scientific officer post at RNA medicines outfit Orna Therapeutics . “It’s just such a fantastic time for biologics right now. You’re seeing just a renaissance. All the technology is coming to fruition,” Mabry said. With the Series A, Hillstar expects to get into the clinic next year with its first biologic. The startup will begin in axial spondyloarthritis, or axSpA. The inflammatory condition leads to lower back pain, causing arthritis in the spine and other joints and organs. Approved medicines for the condition include Novartis’ Cosentyx, UCB’s Bimzelx and AbbVie’s Rinvoq . Others, like Acelyrin, once had ambitions in the space. Hillstar’s HSB-101 biologic targets TRBV9 + T cells. The goal is to invoke an “immune reset,” Mabry said. Beyond its lead asset, Hillstar could go into cold agglutinin disease, or CAD, according to a job posting for the company. In the rare condition, a patient’s immune system prematurely kills red blood cells. Sanofi sold Enjaymo, its approved drug for the condition, to Recordati for $825 million in October. “It’s still an area that we’re exploring,” Mabry said of CAD. “What we’ve been able to generate is a proprietary dataset using patient samples in that area, so we’re very excited about that as one of many different autoimmune diseases that we can go after.” Leading the biotech’s development is former Boston Pharmaceuticals clinical development SVP Mitchell Keegan. Hillstar’s chief operating officer is Lauren Mifflin, a principal of company creation at one of the startup’s key investors, Frazier Life Sciences. Hillstar’s board includes Mabry, Ingram, Novo Holdings senior partner Kenneth Harrison, Frazier General Partner Dan Estes, Droia Managing Partner Luc Dochez and Droia Partner Matthias Van Woensel. Mabry emphasized that the startup is an asset-focused company with drugs near the clinic — a profile investors have favored over the last few years of a moribund biotech sector. “We’re an asset company, a pipeline company — we’re not a platform technology company,” Mabry said. “That really changes the way you can run a biotech company. It changes the way you use the capital.” Along with the investment funds, another key Hillstar backer is Hummingbird Bioscience, a Singapore-based biotech that originated about a decade ago and that has antibody and antibody-drug conjugate platforms. Earlier this month, Frazier and Novo Holdings backed an ADC spinout from Hummingbird called Callio Therapeutics . “They’ve been a great shareholder for us and so being able to leverage them as part of our development, but also gaining access to other technologies that provide a lot of insight into development, that’s been a great partnership for us,” Mabry said of Hummingbird.

Drug ApprovalImmunotherapy

17 Mar 2025

·www.fiercebiotech.com

Incyte posts phase 3 skin condition wins but details disappoint, sinking stock

While Incyte called the data positive, investors were unconvinced and sent the biotech’s share price down.\n Incyte has delivered a pair of pivotal wins for an oral JAK inhibitor in an inflammatory skin condition. But with the placebo-adjusted response rate down on phase 2, the results drew unfavorable comparisons to rival data and triggered a 15% drop in the biotech’s share price. The JAK1 inhibitor, povorcitinib, could offer an oral alternative to biologics in multiple indications and, if approved, partly offset the loss of exclusivity of Incyte\'s JAKi Jakafi later this decade. Incyte took the candidate into phase 3 trials in the skin condition hidradenitis suppurativa (HS) after seeing (PDF) placebo-adjusted response rates of up to 27.7% in a mid-stage study. Asked by analysts at recent investor events, Incyte executives declined to name the number they were targeting in the phase 3 trials but did say they expected to see a profile that is consistent with the earlier trial. The primary endpoints looked at the number of patients who had a 50% or greater reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count. In the first study, around 40% of patients on both the low and high dose met the criteria, versus around 30% on placebo. The drug and placebo figures in the second trial were around 42% and 29%, respectively. Adjusted for placebo, the response rates at the low and high dose were 10.5% and 10.9%, respectively, in the first trial. The figure for both doses was 13.7% in the second trial. In the earlier phase 2 trial, Incyte reported placebo-adjusted results of 17.3% and 27.7%, respectively, at the low and high doses used in the pivotal studies. Incyte saw higher placebo-adjusted results in a predefined subgroup of phase 3 patients who previously took a biologic. The biotech also found more people on povorcitinib had a 75% or greater improvement, experienced a reduction in flares and reported a more than three-point improvement on a pain scale. The overall safety profile of povorcitinib was consistent with previous data, according to Incyte.While the biopharma called the data positive, investors were unconvinced and sent the biotech’s share price down around 15% to just $58 in early premarket trading. The drop may reflect unfavorable comparisons between the phase 3 data and both Incyte’s midphase results and the evidence on rival biologics. UCB won approval for Bimzelx in HS after linking the biologic to placebo-adjusted response rates of 19% and 20% after 16 weeks in two phase 3 trials. Novartis’ biologic Cosentyx is also approved in the indication. Povorcitinib has the advantage of oral administration but the data leave scope to question the size of the opportunity that will be open to the small molecule.

Clinical ResultPhase 3Phase 2Drug Approval

17 Mar 2025

·endpts.com

Incyte's stock sinks as pivotal skin disease data disappoint

Incyte’s topline pivotal data for its oral therapy for a painful inflammatory skin condition appear somewhat disappointing, with efficacy falling short of analysts’ expectations and in comparison with marketed drugs like UCB’s Bimzelx. The company’s shares $INCY fell about 10% on Monday morning. Incyte said Monday that the STOP-HS1 and STOP-HS2 studies of povorcitinib met their primary endpoints in patients with moderate-to-severe hidradenitis suppurativa (HS). After three months of treatment, significantly more patients given the JAK1 inhibitor than those given placebo had a reduction of at least 50% in the number of abscesses and inflammatory nodules, with no increase in abscess or draining tunnel count. This measure is known as HiSCR50. But the improvements over placebo were not as extensive as some had hoped. With the lower dose of povorcitinib — 45 mg once daily — the HiSCR50 delta was 10.5 percentage points in STOP-HS1 and 13.7 points in STOP-HS2. The differences versus placebo seen with the higher dose — 75 mg per day — were almost identical. That’s an odd finding, since a higher dose would be expected to work better. “We’ll have to wait for longer-term follow-up to see if there’s a separation of the 45 and 75 [mg doses],” Incyte head of R&D Pablo Cagnoni said during an analyst call to discuss the data. He added that Incyte plans to provide more data on this point later this year. Incyte also said the drug’s efficacy was better in patients who had previously been treated with biologics. Here the deltas over placebo were larger, but the p-value for the difference between the 45 mg dose and placebo in the HS-1 trial was 0.096, missing the generally accepted threshold for significance. William Blair analysts pointed out that the data came in well below the Phase 2 results, which showed placebo-adjusted HiSCR50 response rates of 18 to 28 percentage points. They added that even on an absolute basis, the Phase 3 HiSCR50 response rates for povorcitinib were markedly lesser than those seen in Phase 2. Incyte intends to wait for further data from the trial before seeking approval for the pill, and it’s aiming for an NDA submission at the end of this year or early next year. The Phase 3 data might be good enough for approval, with Incyte saying on the call that it believes regulators will greenlight povorcitinib for both biologic-naïve and -experienced patients. But doctors might have little reason to prescribe the pill when several approved injected drugs still look more effective. For example, in the pivotal HS trials for Bimzelx, the HiSCR50 delta was 19 to 26 percentage points. This was after four weeks of treatment, which is slightly longer than Incyte’s STOP-HS1 and STOP-HS2 trials, but the effect size is much greater. Another competitor is not far behind. There are high expectations for the pivotal data on MoonLake Immunotherapeutics’ antibody sonelokimab in HS. Those data should be revealed in the third quarter of this year.

Clinical ResultPhase 3Phase 2Immunotherapy

100 Deals associated with Bimekizumab

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KEGG	Wiki	ATC	Drug Bank
D11550	Bimekizumab	-	DB12917

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10 top approved records.

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Indication	Country/Location	Organization	Date
Hidradenitis Suppurativa	European Union	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	Iceland	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	Liechtenstein	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	Norway	UCB Pharma SA	30 Apr 2024
Ankylosing Spondylitis	European Union	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	Iceland	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	Liechtenstein	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	Norway	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	European Union	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	Iceland	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	Liechtenstein	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	Norway	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	European Union	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	Iceland	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	Liechtenstein	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	Norway	UCB Pharma SA	15 Jun 2023
Erythrodermic psoriasis	Japan	UCB Japan Co. Ltd.	20 Jan 2022
Psoriasis vulgaris	Japan	UCB Japan Co. Ltd.	20 Jan 2022
Pustular psoriasis	Japan	UCB Japan Co. Ltd.	20 Jan 2022
Arthritis, Psoriatic	European Union	UCB Pharma SA	20 Aug 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Enthesitis-Related Arthritis	Phase 3	Canada	UCB Biopharma SRL	11 Mar 2025
Enthesitis-Related Arthritis	Phase 3	France	UCB Biopharma SRL	11 Mar 2025
Enthesitis-Related Arthritis	Phase 3	Germany	UCB Biopharma SRL	11 Mar 2025
Enthesitis-Related Arthritis	Phase 3	Poland	UCB Biopharma SRL	11 Mar 2025
Enthesitis-Related Arthritis	Phase 3	Spain	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Canada	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	France	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Germany	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Poland	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Spain	UCB Biopharma SRL	11 Mar 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05292131 (CTgov)	Phase 1	-	121	Bimekizumab (Bimekizumab-AI-2mL (Test))	gbzpfncjbx(mysfyition) = czaziehvoh jnzrtphxlf (kbuzppgbsc, cmvmhvdxap - wjjockzdua) View more	-	10 Apr 2025
				Bimekizumab (Bimekizumab-AI-2x1mL (Reference))	gbzpfncjbx(mysfyition) = ranvnsjafi jnzrtphxlf (kbuzppgbsc, tfkecdkajh - ejnfigetqo) View more
NCT04255862 (CTgov)	Phase 1	-	71	bimekizumab (Bimekizumab-SS-2mL (Test 1))	pyeskzljtw(wkvuijnqon) = ifrxrgjclj juwepsyhsz (vqzsinrmyv, 34.2) View more	-	10 Apr 2025
				Bimekizumab-SS (Bimekizumab-SS-2x1mL (Reference 1))	pyeskzljtw(wkvuijnqon) = qtnidmzoiw juwepsyhsz (vqzsinrmyv, 31.3) View more
pooled results from integrated phase IIb/III clinical studies (Pubmed \| RMD Open)	Phase 2/3	Arthritis, Psoriatic \| Axial Spondyloarthritis	-	Bimekizumab 160 mg every 4 weeks	ievsennsgf(xdmeugxycv) = EAIR/100 PY of nasopharyngitis was 8.2 in axSpA and 7.7 in PsA mzfbstaprs (jsbaweoiwt ) View more	Positive	01 Apr 2025
NCT03766685 (Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Chronic large plaque psoriasis	-	Bimekizumab 320 mg via 2 mL Safety Syringe	vjyziyzkni(rryosfxzbv) = all adverse device effects reported were mild and did not lead to discontinuation lwxwcnbwqt (okbpwwulre ) View more	-	29 Mar 2025
				Bimekizumab 320 mg via Auto-injector
NCT04242446 (BE HEARD I, CTgov)	Phase 3	Hidradenitis Suppurativa	505	placebo (Placebo)	ztohdzobrj = lwjpskuztc ubmzgbbeai (hpasduzikf, cgwzbpmkhy - luzmzzekpa) View more	-	09 Jan 2025
				BKZ (BKZ Dosing Regimen 1)	ztohdzobrj = gfswwljxrk ubmzgbbeai (hpasduzikf, ffveeszmtb - haryaaqvpy) View more
BE AGILE (Pubmed \| RMD Open)	Phase 2	Ankylosing Spondylitis \| Axial Spondyloarthritis	-	Bimekizumab 160 mg every 4 weeks	hkhovmvwjw(kfywvdzouv) = aestvyiprf fpvhsajhnn (gbfkchspvk ) View more	Positive	01 Jan 2025
NCT03598790 (BE BRIGHT, CTgov)	Phase 3	Plaque psoriasis	1,353	BKZ (Cohort A: BKZ 320 mg Q8W)	gkpntihbau = fxkejeyodz wtwvifvrjh (dgclcjljdx, fxgehgjexz - isolxxhrdw) View more	-	06 Dec 2024
				BKZ (Cohort A: BKZ 320 mg Q4W)	gkpntihbau = jibdketojk wtwvifvrjh (dgclcjljdx, rwbibcvebg - baykblpywe) View more
NCT04242498 (BE HEARD II, CTgov)	Phase 3	Hidradenitis Suppurativa	509	placebo (Placebo)	vomrtckolw = pqvtonkcqr dfhkjbuvun (oyhbjhhedd, wovpcawnpr - jvisuakyit) View more	-	05 Dec 2024
				BKZ (BKZ Dosing Regimen 1)	vomrtckolw = gyobuahlme dfhkjbuvun (oyhbjhhedd, cpdmrjtohk - ytdwbunjlg) View more
Pubmed \| Ann Rheum Dis	Not Applicable	Axial Spondyloarthritis	-	Bimekizumab 160 mg	nxwjvjtquf(gewdcpmmqt) = foahcusyet ugdjvdwmqv (lmvlwkacpt )	-	01 Dec 2024
				Placebo	nxwjvjtquf(gewdcpmmqt) = vywuklrxve ugdjvdwmqv (lmvlwkacpt )
NCT03412747 \| NCT03370133 \| NCT03536884 \| NCT03410992 \| NCT03598790 (BE VIVID \| BE READY \| BE SURE \| BE BRIGHT \| BE RADIANT, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Psoriasis	1,107	Bimekizumab	qrvlyzkktp(hcookvogtn) = wvzirnoyqm vukvnwlyxs (qcvtsgbzvc ) View more	Positive	01 Dec 2024

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