A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects

This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.

Start Date30 Nov 2022

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20222393 / CompletedPhase 1

评估IBI353在中国健康受试者中多次口服给药的药代动力学、安全性和耐受性的随机、双盲、安慰剂对照、I期临床研究

[Translation] A randomized, double-blind, placebo-controlled, Phase I clinical study to evaluate the pharmacokinetics, safety and tolerability of IBI353 after multiple oral administration in healthy Chinese subjects

主要目的：评估IBI353在中国健康受试者中多次口服给药后的药代动力学特征。次要目的：评估IBI353在中国健康受试者中多次口服给药后的安全性和耐受性。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of IBI353 after multiple oral administration in healthy Chinese subjects. Secondary objective: To evaluate the safety and tolerability of IBI353 after multiple oral administration in healthy Chinese subjects.

Start Date24 Nov 2022

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

[+2]

NCT05469464 / Active, not recruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

Start Date11 Jul 2022

Sponsor / Collaborator

UNION Therapeutics A/S

100 Clinical Results associated with Orismilast

100 Translational Medicine associated with Orismilast

100 Patents (Medical) associated with Orismilast

Literatures (Medical) associated with Orismilast

01 May 2024·Journal of the European Academy of Dermatology and Venereology : JEADV

Orismilast for the treatment of mild to severe hidradenitis suppurativa: Week 16 data from OSIRIS, a Phase 2a, open‐label, single‐centre, single‐arm, dose‐finding clinical trial

Article

Author: Jemec, G B E ; Saunte, D M ; Sedeh, F B ; Taudorf, E H ; Frederiksen, C G

Abstract:

Background:

Hidradenitis suppurativa (HS) is a disease with an unmet need for treatment.

Objective:

To examine tolerability, safety and efficacy of oral phosphodiesterase‐4 (PDE4) inhibitior orismilast 10–40 mg twice daily (BID) in HS.

Methods:

A Phase 2a, single‐arm, single‐centre, open‐label, 16‐week trial in HS patients. Adjustments in maximal dose and titration were allowed, to improve tolerability, dividing the study population in two groups who completed and discontinued 16 weeks of treatment.Descriptive statistics were applied to efficacy data from patients who completed treatment and patients who discontinued treatment prematurely. A last‐observation‐carried‐forward (LOCF) approach was used for patients who discontinued treatment.The primary endpoint was percent change in the total number of abscesses and nodules (AN‐count) at Week 16, with the HS Clinical Response with a 50% reduction in the AN‐count (HiSCR50) as key secondary endpoint.

Results:

Of the 20 patients included, 9 completed 16 weeks of treatment and 11 discontinued treatment prematurely. The mean AN‐count was reduced with 33.1% in patients who completed treatment and with 12.0% in patients who discontinued. HiSCR50 was achieved by 67.0% and 27.0% of patients who completed and discontinued treatment, respectively. Most adverse events were mild to moderate.

Conclusions:

Oral orismilast demonstrated a dose‐dependent tolerability, with mild to moderate adverse effects. Further, the results of this exploratory trial indicate that orismilast may lead to clinical improvements in HS. However, larger trials with tolerable dose ranges are warranted.The Trial is registered at Clinicaltrials.gov (UNI50007201) and EudraCT.ema.europa.eu (2021‐000049‐42).

01 Mar 2024·Journal of the American Academy of Dermatology

Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)

Article

Author: Blauvelt, Andrew ; Hunter, Hamish J A ; Gooderham, Melinda ; Carlsson, Anna ; Andres, Philippe ; Langley, Richard G ; Strober, Bruce E ; Kjøller, Kim D ; Warren, Richard B ; Egeberg, Alexander ; Mrowietz, Ulrich ; Sommer, Morten O A ; French, Lars E ; Soerensen, Per

BACKGROUND:

Orismilast is a novel oral phosphodiesterase-4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis.

OBJECTIVE:

To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis.

METHODS:

This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy end points were analyzed using multiple imputation.

RESULTS:

Of 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast vs placebo. Orismilast showed significant improvements in the primary end point, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast -52.6% to -63.7% and placebo, -17.3%; all P <.001). Greater proportions receiving orismilast achieved PASI75 (39.5%-49.0%; P <.05) and PASI90 (22.0%-28.3%; P <.05 for 20 and 40 mg) vs placebo (PASI75, 16.5% and PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed.

LIMITATIONS:

Small sample size, disease severity imbalance between groups, limited duration and diversity in study population.

CONCLUSION:

Orismilast demonstrated greater efficacy vs placebo and a safety profile in line with PDE4 inhibition.

01 Apr 2023·Journal of the European Academy of Dermatology and Venereology : JEADV

Pharmacology of orismilast, a potent and selective PDE4 inhibitor

Article

Author: Guttman, Emma ; Warren, Richard B. ; Kjøller, Kim ; Skak‐Nielsen, Tine ; Weiss, Anne ; Silverberg, Jonathan I. ; Andres, Philippe ; Strober, Bruce ; Felding, Jakob ; Sommer, Morten O. A. ; French, Lars E. ; Tutkunkardas, Deniz

Abstract:

Background:

There remains an unmet need for oral medications that are safe and efficacious for long‐term management of chronic inflammatory skin diseases (CISD). Inhibition of phosphodiesterase 4 (PDE4) can modulate a broad range of pro‐inflammatory cytokines that play a major role in CISD pathogenesis. Orismilast is a second generation PDE4 inhibitor in clinical development for CISD treatment.

Objectives:

The objective of this study was to examine the PDE4 enzymatic activity and anti‐inflammatory effects of orismilast in vitro, ex vivo, and in vivo.

Methods:

The PDE1‐11 enzymatic activity of orismilast was tested in vitro using a single concentration of 308 nM orismilast. The PDE4 selectivity and inhibitory potency was further examined in a radiometric assay. Orismilast was tested on human whole blood and human peripheral blood mononuclear cells (PBMC) to determine effects on its cytokine secretion and inhibition profile ex vivo. Orismilast was orally administered in a murine model of chronic oxazolone‐induced ear skin inflammation. Ear thickness, a marker of inflammation, and inflammatory cytokines were analysed.

Results:

Orismilast selectively inhibited PDE4 and demonstrated potent inhibition of PDE4B and PDE4D subtype splice variants in vitro. Orismilast inhibited whole blood and PBMC production of tumour necrosis factor α (TNFα), and the secretion of T‐helper (Th)1 (TNFα and IFNγ), Th17 (IL‐22 and IL‐23), and Th2 (IL‐4, IL‐5, and IL‐13) related cytokines in PBMC. In vivo, 10 and 30 mg/kg doses of orismilast significantly reduced ear thickness and inflammation markers (p < 0.0001, respectively).

Conclusion:

Orismilast displayed selective and potent PDE4 inhibition and broad‐spectrum anti‐inflammatory activity in several pre‐clinical models. The results of the study support clinical development of oral orismilast as a novel treatment option for CISD including psoriasis, atopic dermatitis, and hidradenitis suppurativa.

News (Medical) associated with Orismilast

26 Sep 2024

·www.pharmaceutical-technology.com

Union plans Phase III trial for atopic dermatitis after Phase IIb win

Orismilast is a phosphodiesterase-4 (PDE4) inhibitor, which impacts multiple inflammatory mediators causing a pro-inflammatory effect. Image credit: Evgeniia Primavera / Shutterstock. Union Therapeutics is looking to advance its PDE4 inhibitor, orismilast, into a Phase III clinical trial for atopic dermatitis (AD) following positive results from a Phase IIb study for the therapy in the indication. The company is investigating orismilast for multiple dermatological and inflammatory indications , including psoriasis, hidradenitis suppurativa, and ulcerative colitis. Union plans to start a Phase III trial for the therapy in AD once the US Food and Drug Administration (FDA) approves the trial design at an end-of-Phase II meeting. The results from the dose-ranging Phase IIb ADESOS trial (NCT05469464) were presented at the European Academy of Dermatology and Venerology (EADV) 2024 Congress taking place from 25 to 28 September in Amsterdam, Netherlands. “The results from the ADESOS study with orismilast in AD follows positive readouts in psoriasis and hidradenitis suppurativa confirming the potential of orismilast as a safe oral treatment option across immunology,” said Kim Kjøller, co-CEO of Union. Orismilast is a phosphodiesterase-4 (PDE4) inhibitor, which impacts multiple inflammatory mediators causing a pro-inflammatory effect. In 2021, Union licensed out the development and marketing rights to the therapy in China to Innovent Biogics in a deal worth more than $267m. See Also: MHLW approves MSD’s KEYTRUDA for lung and urothelial cancers MHLW approves Eli Lilly’s Kinsula to treat Alzheimer’s in Japan The Phase IIb ADESOS study enrolled 233 patients with moderate to severe atopic dermatitis. The patients received either one of the three doses of orismilast – 20mg, 30mg or 40mg – or a placebo. The trial met its primary endpoint by showing a reduction in eczema area and severity index (ESAI) at 16 weeks. The participants in 20, 30, and 40mg orismilast groups achieved a mean percentage reduction in ESAI of -55.1%, -52.2%, -61.4%, respectively, compared to the -50.4% reduction in the placebo group. The company cited high disease severity at baseline, with a mean ESAI of 23, as the reason for the high ESAI placebo response. The study also met its secondary endpoint of scoring a clear (0) or almost clear (1) response in the Investigator Global Assessment for AD (IGA-AD) at 16 weeks. The 26.3%, 24.3%, and 30.9% participants in 20mg, 30mg, and 40mg orismilast groups achieved 0/1 scores in IGA-AD, compared to 9.5% in the placebo group. The company also noted that treatment groups showed a reduction in CCL17/thymus and activation-regulated chemokine (TARC) skin levels, a biomarker of AD, with “end of treatment levels approaching those of non-lesional skin”. The orismilast groups also observed a four or more-point reduction in the itch numerical rating scale (NRS) two weeks following treatment. The common treatment-associated adverse effects were diarrhoea, nausea and headache.

Clinical ResultPhase 2Phase 3

25 Sep 2024

·www.prnewswire.com

UNION therapeutics announce results from the ADESOS Phase 2b study in atopic dermatitis confirming the potential of orismilast as a first-in-class safe and efficacious oral treatment

Orismilast Phase 2b results in atopic dermatitis (AD) presented today as a late-breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress 2024 Orismilast demonstrated clear treatment effect with statistical significance for all dose arms on the registrational endpoint of IGA0/1 at week 16 Orismilast also demonstrated fast onset of itch reduction as measured by ≥4 point reduction in NRS at week 2 with statistical significance for all dose arms Biomarkers including TARC (CCL17) improved statistically significantly for all orismilast doses compared with placebo Safety and tolerability in line with prior studies with orismilast as well as marketed PDE4-inhibitors, positioning orismilast uniquely as a safe and efficacious oral treatment Orismilast has previously demonstrated efficacy in both psoriasis and hidradenitis suppurativa (HS), and is also being studied in ulcerative colitis (UC) Following a positive End-of-Phase 2 meeting with the FDA, UNION plan to progress orismilast to Phase 3 development in AD HELLERUP, Denmark, Sept. 25, 2024 /PRNewswire/ -- UNION therapeutics A/S ("UNION"), a privately held, clinical stage, pharmaceutical development company focused on immunology, today announces results from the ADESOS Phase 2b study with orismilast in adults with moderate to severe atopic dermatitis presented by Prof. Dr. Eric Simpson at the EADV Congress 2024. Data from the 233 patients randomized and dosed in the study demonstrated that significantly more patients achieved Investigator Global Assessment (IGA) 0/1 responses at Week 16 in orismilast 20mg (n=58), 30mg (n=61), and 40mg (n=59) groups, compared to placebo (n=55) (26.3%, 24.3%, 30.9%, and 9.5%, respectively; all p-values <0.05). Additionally, the efficacy observed using the IGA score was supported by changes in skin levels of TARC (CCL17/thymus and activation-regulated chemokine) - a key disease biomarker of AD. Data showed that TARC skin levels are significantly reduced in the active arms, with end of treatment levels approaching those of non-lesional skin. Mean percentage changes in EASI (Eczema Area and Severity Index) at Week 16 were: -55.1%, -52.2%, -61.4%, and -50.4%, in orismilast 20, 30, 40mg and placebo groups, respectively (p>0.05). Mean EASI at baseline was 23, the least severe reported in a Phase 2b/3 study in moderate to severe AD to date. This likely drove the high EASI placebo response also seen in other recent studies with more moderate patients. In the subgroup of patients with severe disease at baseline (EASI >21), active arms separated from placebo on EASI as well as other endpoints. Additionally, all active arms demonstrated a significant ≥4-point reduction in itch Numerical Rating Scale (NRS) at Week 2, compared to placebo (p <0.05). Additional patient-reported outcomes, including change in pain and sleep NRS, as well as patient global impression of change, were significantly improved in the 20 mg group at Week 2. Most patients with AD report itch as the worst symptom of their disease and therefore reporting a fast onset of action on itch and other patient reported outcomes is important to improving patient quality of life. "The results from the ADESOS study with orismilast in atopic dermatitis (AD) follows positive read outs in psoriasis and hidradenitis suppurativa (HS) confirming the potential of orismilast as a safe oral treatment option across immunology", says Kim Kjøller, Co-CEO of UNION. "We are excited that the results have been presented today as a late-breaking oral presentation by Prof. Dr. Eric Simpson at the EADV Congress 2024. It is always a pleasure being at the conference and discussing the results with leading experts within the field as we plan to progress orismilast to Phase 3 development in atopic dermatitis." No new safety signals were identified, and the safety profile was aligned with that seen for the PDE4 class. The most common TEAE's were diarrhea, nausea, and headache, mainly seen within the first month, mostly mild in severity, with few leading to treatment discontinuation. The safety and tolerability profile of orismilast was confirmed and consistent with the PDE4-class and what was seen in the IASOS study of orismilast in psoriasis and OSIRIS study of orismilast in HS. About the ADESOS Phase 2b study The Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of orismilast in patients with moderate to severe AD. The study included 235 patients who were randomized to three active doses (20mg, 30mg, and 40 mg) of orismilast or placebo administered twice daily. The study was conducted in centers in Europe and in the US. About orismilast Orismilast is a next generation, high potency PDE4 inhibitor targeting the PDE4B/D subtypes linked to inflammation, demonstrating potent inhibition of Th1, Th2 and Th17 pathways. It acts early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1) Orismilast is developed to have more potent anti-inflammatory properties than previously marketed PDE4 inhibitors, enabled by higher selectivity for subtypes PDE4B and D. UNION is developing orismilast as an oral treatment, based on the well-known safety profile of the PDE4 class, across immunology, initially targeting best-in-class or first-in-class positions in atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis and ulcerative colitis (UC). The FDA has cleared UNION's Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for oral orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. About atopic dermatitis AD is a chronic inflammatory skin disease affecting 2.1-4.9 % of the adult population worldwide and is the most common skin disease among children.2) There was approximately 20 million diagnosed moderate-to-severe adult patients with AD in 2023 in the Seven Major Markets (US, France, Germany, Italy, Spain, UK, and Japan).3) Disease symptoms are characterized by recurrent eczematous skin lesions and intense itch. AD has a substantial psychosocial impact on patients and relatives.4) During disease flares, approximately 80% of patients may experience disturbed sleep, which may also disrupt the sleep of family members.5) The disease also appears to impact the mood, and patients have an increased risk of anxiety and depression.6) Sources 1) Blauvelt A et al., Dermatology and Therapy 2023: Next Generation PDE4 Inhibitors that Selectively Target PDE4B/D Subtypes: A Narrative Review - PubMed (nih.gov) & Silverberg J.I. et al., JEADV 2022: & Warren R.B. et al., JEADV 2022: 2) Barbarot S et al,. Allergy 2018: 3) EvaluatePharma 2023 4) Laughter MR et al., British Journal of Dermatology 2021: 5) Eichenfield LF et al., Journal of the American Academy of Dermatology 2014: 6) Drucker AM et al., The Journal of Investigative Dermatology 2017: Contacts Morten Boesen, Chief Financial Officer, UNION therapeutics A/S +45 2381 5487 [email protected] Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S +45 5385 3044 [email protected] About UNION therapeutics UNION therapeutics is a privately held, clinical stage, pharmaceutical development company focused on immunology. UNION's lead asset is orismilast, a next generation, high potency PDE4B/D inhibitor, for a range of immunological diseases e.g., atopic dermatitis (AD) and hidradenitis suppurativa (HS). Orismilast holds the potential to become the first safe oral treatment in AD. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at This information was brought to you by Cision WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Fast TrackImmunotherapy

20 Sep 2024

·www.prnewswire.com

UNION therapeutics to present orismilast Phase 2b results in atopic dermatitis as a late-breaking oral presentation at the EADV Congress 2024

ADESOS Phase 2b results with orismilast in atopic dermatitis (AD) selected as late-breaking oral presentation Additionally, two posters on data from the pioneering use of tape stripping for biomarker analysis in the ADESOS study and additional ADESOS Phase 2b results Orismilast is a next generation, high potency PDE4 B/D selective inhibitor with reported positive results from a Phase 2b study in psoriasis and Phase 2, IIT, study in hidradenitis suppurativa (HS); orismilast is currently being evaluated in an ongoing Phase 2, IIT study in ulcerative colitis (UC) UNION plan to progress orismilast to Phase 3 development in AD HELLERUP, Denmark, Sept. 20, 2024 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately held, clinical stage, pharmaceutical development company focused on immunology, today announced ADESOS Phase 2b results selected as a late-breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress 2024 on September 25-28, 2024, in Amsterdam, Holland. New data from the ADESOS Phase 2b study of orismilast in AD will be presented by Prof. Dr. Eric Simpson. The efficacy and safety results of orismilast from the Phase 2b ADESOS trial will also be presented as an poster. Additionally, one poster on the molecular effects in the skin of AD patients after oral orismilast treatment will be presented. "Despite the current developments of new treatments in AD, there is a clear need for safe and efficacious oral treatments. Impact on patients' experience of itch and pain along with lesional improvements are key to determine the relevance of a treatment", says Prof. Dr. Eric Simpson. "I am excited to present the results from the Phase 2b ADESOS study at the EADV Congress 2024, showing that orismilast offers the promise as a novel treatment option in AD with early impact on patients' burden of disease, including significant itch reduction from 1 week of treatment." "We are pleased that the Phase 2b results from the ADESOS study have been selected as a late-breaking oral presentation at the EADV Congress 2024", adds Kim Kjøller, Co-CEO of UNION. "Additionally, we appreciate the opportunity to present two posters on ADESOS Phase 2b results and the molecular effects in the skin after treatment with orismilast, following the pioneering use of tape strips to analyze the effect on relevant disease biomarkers. We look forward to being at the conference and discuss the results with leading experts within the field as we are progressing orismilast in Phase 3 development in atopic dermatitis." Presentation details for the late-breaking presentation Presentation: Orismilast efficacy in adults with moderate-to-severe atopic dermatitis in a phase 2b trial: early impact on itch and patient-reported outcomes Session code: D1T01.1 Presenter: Prof. Dr. Eric Simpson, Professor of Dermatology, School of Medicine, Frances J. Storrs, M.D. Medical Dermatology Professor, Dermatology, School of Medicine Date and time: Wednesday September 25, 2024, at 2:30-2:45 PM GMT Details for the posters Poster title: Molecular effects in the skin of atopic dermatitis after oral treatment with orismilast ID: 5905 Poster number: P3569 Poster title: Efficacy and safety of orismilast, a potent PDE4B/D inhibitor, in adults with moderate-to-severe atopic dermatitis: a Phase 2b randomized, double-blinded, placebo-controlled clinical trial (ADESOS) ID: 4256 Poster number: P0598 About orismilast Orismilast is a next generation, high potency PDE4 inhibitor targeting the PDE4B/D subtypes linked to inflammation, demonstrating potent inhibition of Th1, Th2 and Th17 pathways. It acts early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1) UNION is developing orismilast as an oral treatment across immunology. Based on the well-known safety profile of the PDE4 class, initially targeting best-in-class or first-in-class positions in atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis and ulcerative colitis (UC). The FDA has cleared UNION's Investigational New Drug (IND) application for orismilast and granted Fast Track designation for orismilast for the treatment of moderate to severe AD as well as for the treatment of moderate to severe HS. Sources Blauvelt A et al., Dermatology and Therapy 2023: Next Generation PDE4 Inhibitors that Selectively Target PDE4B/D Subtypes: A Narrative Review - PubMed (nih.gov) & Silverberg J.I. et al., JEADV 2022: & Warren R.B. et al., JEADV 2022: Contacts Morten Boesen, Chief Financial Officer, UNION therapeutics A/S +45 2381 5487 [email protected] Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S +45 5385 3044 [email protected] About UNION therapeutics UNION therapeutics is a privately held, clinical stage, pharmaceutical development company focused on immunology. UNION's lead asset is orismilast, a next generation, high potency PDE4 B/D inhibitor, for a range of immunological diseases e.g., atopic dermatitis (AD) and hidradenitis suppurativa. Orismilast holds the potential to become the first safe oral treatment in AD. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at This information was brought to you by Cision WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Fast TrackClinical Result

100 Deals associated with Orismilast

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autoimmune Diseases	Phase 2	CN	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022
Autoimmune Diseases	Phase 2	DK	UNION Therapeutics A/S	30 Jan 2022
Hidradenitis Suppurativa	Phase 2	-	UNION Therapeutics A/S	01 Oct 2021
Dermatitis, Atopic	Phase 2	DK	UNION Therapeutics A/S	11 Jul 2020
Psoriasis vulgaris	Phase 2	DE	Leo Pharma, Inc.	01 Sep 2016
Plaque psoriasis	Phase 2	DE	LEO Pharma A/S	05 Jun 2016
Colitis, Ulcerative	Phase 2	-	UNION Therapeutics A/S	-
Psoriasis	Phase 2	-	UNION Therapeutics A/S	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05469464 (PRNewswire) Manual	Phase 2	Dermatitis, Atopic	233	Orismilast 20mg	untkmepwvp(ttmxkykuei) = cgeyzggtji wvxqtzoyzz (oixsxlcesc ) View more	Positive	25 Sep 2024
				Orismilast 30mg	untkmepwvp(ttmxkykuei) = wkiimaotnr wvxqtzoyzz (oixsxlcesc ) View more
NCT05190419 (IASOS, CTgov)	Phase 2	Plaque psoriasis	202	Placebo (Placebo Tablets BID)	pjlqtwbcsz(dtigjozeas) = otypszgddi faaoztdfab (ixdpcagznp, lggnurtuhk - wvvsjjmxof) View more	-	16 Apr 2024
				Orismilast modified release tablets (Orismilast Modified Release Tablets 20 mg BID)	pjlqtwbcsz(dtigjozeas) = zjuvzkqcpf faaoztdfab (ixdpcagznp, brlsnplcgd - lzndyjvzvt) View more
EADV2023	Phase 2	Hidradenitis Suppurativa	20	Orismilast 10 mg	cnuulxhigj(fggulbjymx) = hdqtwinnqm lytxnbhkxa (hvfmitjjor ) View more	-	11 Oct 2023
				Orismilast 40 mg BID	cnuulxhigj(fggulbjymx) = stqnesjzel lytxnbhkxa (hvfmitjjor ) View more
NCT05190419 (IASOS, EADV2023)	Phase 2	Psoriasis	202	Orismilast 20 mg	frhdudkryr(avsjppopsq) = ggwqvdfxzy vuhzovlssq (gtctdcxzsn ) View more	Positive	11 Oct 2023
				Orismilast 30 mg	frhdudkryr(avsjppopsq) = gjepliutgs vuhzovlssq (gtctdcxzsn ) View more
EADV2022	Phase 2	Psoriasis	36	Orismilast IR	ofnkjxcuaj(mobqvacgjg) = The high GI AE (88.9%) and discontinuation rates in the phase 2a trial led to the development of an MR tablet to improve the GI tolerability by changing the release profile of orismilast. In the phase 1 trial, part 1 showed that orismilast MR achieved comparable PK, including t max , to orismilast IR, despite a slower dissolution rate. No nausea was observed in the MR arm and the rate of GI AEs was lower in the MR arm vs the IR arm (16.7% vs 33.3%, respectively). wfeqboxmet (ftgsqtxlxb )	-	07 Sep 2022
				Placebo

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