Hidradenitis Suppurativa – Drug Pipeline Landscape, 2023
Hidradenitis suppurativa is a chronic skin condition that features pea-sized to marble-sized lumps under the skin causing abscesses and scarring. These deep-seated lumps typically develop where skin rubs together, such as the armpits, groin, between the buttocks and under the breasts.
The exact cause of Hidradenitis suppurativa is unknown but risk factors include age, sex, race, inheritance, overweight, smoking, blocked hair follicles with keratin and a combination of genetic and environmental factors.
Hidradenitis suppurativa symptoms include blackheads appearing as small pitted skin areas and painful pea-sized lumps. Some bumps or sores get bigger, break open, drain pus with an odor, cysts and scars.
Hidradenitis suppurativa is diagnosed by physical examination based on skin appearance and signs and symptoms. If pus or liquid drainage is seen, a lab test will be conducted to check the infection.
Hidradenitis suppurativa is treated by surgery and drugs like antibiotics, steroids and hormonal therapy such as birth control pills, spironolactone or finasteride.
The pipeline of Hidradenitis suppurativa treatment market consists of a great variable of drugs. Interleukin-17A (IL17A) Inhibitors, Mitogen-Activated Protein Kinase-Activated Protein Kinase-2 (MK2) Inhibitors, Murine Double Minute 2 (MDM2) Inhibitors, Interleukin-1 Receptor-Associated Kinase 4 (IRAK-4) Inhibitors, and some others are the most highlighted class of this indication. Ongoing research and current trials have the potential to change the market.
More than 30 key players, including pharma giants such as Abbvie, Boehringer Ingelheim, Eli Lilly, Novartis, Novartis, Pfizer and others are working to bring novel therapies that overcome the roadblocks of AML treatment pipeline.
Report Highlights
Global Insight Service’s, “Hidradenitis Suppurativa – Drug Pipeline Landscape, 2023,” an overview of the Hidradenitis Suppurativa pipeline drugs. This report covers detailed insights on Hidradenitis Suppurativa drugs under development, assessment by target, mechanism of action, route of administration and molecule type. Product pipeline by companies, stage of development and key regulatory designations, deals and milestones have been presented to gain insights and thus help industry participants for decision making. Hidradenitis Suppurativa pipeline report helps gaining insights on drugs which are under development stage of drug development process across globally. Global Insight Services aims to cover all the drug attributes, deals, regulatory milestones and all the upcoming milestones.
Recent Developments
In February 2023, Incyte announced new 52-week results from Phase II study evaluating the efficacy and safety of povorcitinib in adults’ patients with hidradenitis suppurative (HS). These data were presented as an oral presentation at the 12th Conference of the European Hidradenitis Suppurative Foundation, held in Florence, Italy.
In February 2023, MoonLake Immunotherapeutics AG announced that it has completed enrolment of the target 210 patients in its global Phase II clinical trial evaluating sonelokimab in moderate to severe hidradenitis suppurativa (HS).
In January 2023, Affibody’s partner ACELYRIN announced top line 12-week open label data from a Phase IIb/III trial of izokibep in patients with moderate to severe Hidradenitis Suppurative (HS).
In January 2023, UNION Therapeutics A/S announced US FDA has granted Fast Track Designation to oral orismilast for the treatment of moderate to severe HS.
In October 2022, Amgen acquired Chemocentryx for USD 52 per share in cash, representing an aggregate merger consideration of approximately USD 3.7 billion. TAVNEOS, which is being studied for inflammatory diseases such as hidradenitis suppurativa (HS), a severe and deforming chronic dermatological condition, and complement 3 glomerulopathy (C3G), a rare genetic kidney disease, is included in the acquisition.
Key Products
AIN-457 (secukinumab) is under development for the treatment of moderate-to-severe hidradenitis suppurativa (HS). In September 2022, Novartis announced the results from two pivotal Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate to severe hidradenitis suppurative (HS) with a favourable safety profile. These Phase III data have been submitted to regulatory authorities in Europe.
Bimekizumab (BIMZELX) is under development for the treatment of moderate-to-severe hidradenitis suppurativa. in December 2022. UCB announced top-line results from two Phase III studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safety of bimekizumab in adults with moderate-to-severe hidradenitis suppurativa.
ATI-450 (Zunsemetinib, CDD-450) is under development for the treatment of hidradenitis suppurativa. In 2017, Aclaris Therapeutics acquired Confluence Life Science Inc. At the closing, Aclaris paid approximately USD 10 million in cash and issued approximately 350,000 shares of its common stock, with a value of approximately USD 10 million on the closing data, to the former equity holders of Confluence.
KT-474 is under development for the treatment of hidradenitis suppurativa. In July 2020, Kymera Therapeutics entered into a multi-program strategic collaboration with Sanofi to develop and commercialise protein degrader therapies targeting IRAK4 in patients with immune inflammatory diseases. In December 2022, Kymera Therapeutics announced positive clinical results from the patient cohort portion of its KT-474 (IRAK4) Phase I clinical trial.
| Drugs | Company | Phase | Molecule Type | MoA | RoA |
|---|---|---|---|---|---|
| AIN-457 | Novartis AG | Pre-Registration | Monoclonal Antibody | Interleukin-17A (IL17A); Interleukin-17A (IL17A) Inhibitor | Subcutaneous |
| Bimekizumab | UCB S.A. | Phase III | Monoclonal Antibody | Interleukin 17A (IL-17A), Interleukin 17F (IL-17F); Interleukin 17A (IL-17A), Interleukin 17F (IL-17F) Inhibitor | Parenteral |
| ATI-450 | Aclaris Therapeutics Inc. | Phase II | Small Molecule | Mitogen-Activated Protein Kinase-Activated Protein Kinase-2 (MK2); Mitogen-Activated Protein Kinase-Activated Protein Kinase-2 (MK2) Inhibitor | Oral |
| KT-474 | Kymera Therapeutics Inc | Phase I | Small Molecule | Interleukin-1 Receptor-Associated Kinase 4 (IRAK-4); Interleukin-1 Receptor-Associated Kinase 4 (IRAK-4) Inhibitor | Oral |
Figure: Number of Drugs for The Treatment of Hidradenitis suppurativa Under Each Stage of Development
Methodology
The research process includes extensive secondary research on public domain and other authentic sources carried out to add or update the pipeline products information. The secondary research sources include, but are not limited to company websites, annual reports, financial reports, company pipeline chart, investor presentations and SEC filings, journals and conferences, clinical trials registries.
Scope
The pipeline landscape report consists of pipeline product based on several stages of development ranging from discovery to Pre-Registration. The report provides a review of pipeline therapeutics for Hidradenitis Suppurativa by companies based on information derived from company and industry-specific sources. The pipeline report covers assessment of Hidradenitis Suppurativa therapeutics by mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. Comprehensive profiles of the pipeline products with details such as company overview, development stage; molecule type, target, mechanism of action, route of administration, dosage form, regulatory designations, key deals and key upcoming milestones.
Reasons to Buy
Helps to find and recognize significant therapeutics under development for Hidradenitis Suppurativa. Thorough understanding of Hidradenitis Suppurativa pipeline structure and helps in developing corrective measures for pipeline projects. Effective R&D strategies can be developed with deep knowledge on competitor information, analysis, and insights. Plan of collaborations from various industry partners that have role in some or the other stage of drug development like contract manufacturing, co-development, contract research organization and commercialization etc.
Helps to create in-licensing and out-licensing opportunities by identifying prospective partners with attractive projects to expand business potential and scope.
Frequently Asked Questions:
• What is Hidradenitis suppurativa?
• What are the Causes, Signs and Symptoms of Hidradenitis suppurativa?
• How is Hidradenitis suppurativa diagnosed?
• What are the most common treatments available for Hidradenitis suppurativa?
• How many/which companies are developing Hidradenitis suppurativa drugs?
• How many Hidradenitis suppurativa drugs are under development by each company and their stage of development?
• How many emerging drugs are in late-stage, mid-stage and early-stage of development for the Hidradenitis suppurativa treatment?
• What are the key collaborations, mergers and acquisitions, licensing activities related to the Hidradenitis suppurativa therapeutics?
• What are the molecule types, target, mechanism of action and route of administration of emerging drugs under development for the treatment of Hidradenitis suppurativa?
• What are the clinical studies available for Hidradenitis suppurativa and their status?
• What are the key regulatory designations that have been granted to the treatment emerging drugs?
• What are the key upcoming milestones for Hidradenitis suppurativa drugs?
• How many drugs are under Inactive or Discontinued for the treatment of Hidradenitis suppurativa?
Table of Contents
List of Tables
List of Figures
1. Introduction
1.1 Hidradenitis Suppurativa – Pipeline Drugs, 2023 – Coverage
2. Disease Overview – Hidradenitis Suppurativa
2.1 Causes
2.2 Signs and Symptoms
2.3 Diagnosis
2.4 Disease Management
3. Hidradenitis Suppurativa – Pipeline Drugs Development – Overview
3.1 Comparative Analysis by Stage of Development
3.2 Number of Products under Development by Companies, 2023
3.3 Products under Development by Companies, 2023
4. Assessment of Therapeutics
4.1 Assessment by Target
4.2 Assessment by Mechanism of Action
4.3 Assessment by Molecule Type
4.3 Assessment by Route of Administration
5. Drug Profiles
5.1 Late- Stage Drugs – Pre-Registration
5.1.1 AIN457
5.2 Clinical Stage Drugs – Phase III
5.2.1 Bimekizumab
5.2.2 Izokibep
5.2.3 Povorcitinib
5.2.4 Vilobelimab
5.3 Clinical Stage Drugs – Phase II
5.3.1 ATI-450
5.3.2 Avacopan
5.3.3 BDB-001
5.3.4 Bermekimab
5.3.5 Brepocitinib
5.3.6 CFZ533
5.3.7 CJM112
5.3.8 Fostamatinib
5.3.9 KPL-404
5.3.10 LOU064
5.3.11 LTX-109
5.3.12 Lutikizumab
5.3.13 LY3041658
5.3.14 LYS006
5.3.15 MAS825
5.3.16 Orismilast
5.3.17 PTM-001
5.3.18 RIST4721
5.3.19 Ruxolitinib
5.3.20 Sonelokimab
5.3.21 Spesolimab
5.3.22 Upadacitinib
5.4 Clinical Stage Drugs – Phase I
5.4.1 AT193
5.4.2 CSL324
5.4.3 KT-474
5.5 Clinical Stage Drugs – IND/CTA Filed
5.5.1 IMG-008
5.5.2 NBL-012
5.6 Early-Stage Drugs – Preclinical
5.6.1 AFX 3921
5.6.2 HEN-001
5.7 Early-Stage Drugs – Discovery
5.7.1 RGRN-305
6. Key Regulatory Designations
7. Key Deals
8. Key Upcoming Milestones
9. Key Companies Involved
9.1 AbbVie
9.2 Acelyrin Inc
9.3 Aclaris Therapeutics Inc
9.4 Afecta Pharmaceuticals Inc
9.5 Amgen
9.6 Aristea Therapeutics Inc
9.7 Azora Therapeutics Australia Pty Ltd
9.8 Boehringer Ingelheim
9.9 CSL Behring
9.10 Eli Lilly and Company
9.11 Gregor Jemec
9.12 Henlez
9.13 Incyte Corporation
9.14 InflaRx GmbH
9.15 Inmagene Biopharmaceuticals Ltd
9.16 Janssen Research & Development LLC
9.17 Kiniksa Pharmaceuticals Ltd
9.18 Kymera Therapeutics Inc
9.19 MoonLake Immunotherapeutics AG
9.20 NovaRock Biotherapeutics Inc
9.21 Novartis Pharmaceuticals
9.22 Pfizer
9.23 Pharma Holdings AS
9.24 Phoenicis Therapeutics
9.25 Regranion LLC
9.26 Rigel Pharmaceuticals
9.27 Staidson (Beijing) Biopharmaceuticals Co Ltd
9.28 UCB Biopharma SRL
10. Dormant Drugs
10.1 Inactive Drugs
10.2 Discontinued Drugs
11. Appendix
List of Tables
Table 1.1 Number of Products Under Development for Hidradenitis Suppurativa
Table 1.2 Number of Products Under Development by Companies
Table 1.3 Products Under Development by Companies
Table 1.4 Products by Targets
Table 1.5 Products by Mechanism of Action
Table 1.6 Products by Molecule Type
Table 1.7 Products by Route of Administration
Table 2.1 Clinical Trial Details – Bimekizumab/UCB Biopharma SRL
Table 2.2 Clinical Trial Details – Izokibep/Acelyrin Inc
Table 2.3 Clinical Trial Details – Povorcitinib/Incyte Corporation
Table 2.4 Clinical Trial Details – Vilobelimab/InflaRx GmbH
Table 2.5 Clinical Trial Details – ATI-450/Aclaris Therapeutics Inc
Table 2.6 Clinical Trial Details – Avacopan/Amgen
Table 2.7 Clinical Trial Details – BDB-001/Staidson (Beijing) Biopharmaceuticals Co Ltd
Table 2.8 Clinical Trial Details – Bermekimab/Janssen Research & Development LLC
Table 2.9 Clinical Trial Details – Brepocitinib/Pfizer
Table 2.10 Clinical Trial Details – CFZ533/Novartis Pharmaceuticals
Table 2.11 Clinical Trial Details – CJM112/Novartis Pharmaceuticals
Table 2.12 Clinical Trial Details – Fostamatinib/Rigel Pharmaceuticals
Table 2.13 Clinical Trial Details – LOU064/Novartis Pharmaceuticals
Table 2.14 Clinical Trial Details – LTX-109/Pharma Holdings AS
Table 2.15 Clinical Trial Details – Lutikizumab/AbbVie
Table 2.16 Clinical Trial Details – LY3041658/Eli Lilly and Company
Table 2.17 Clinical Trial Details – LYS006/Novartis Pharmaceuticals
Table 2.18 Clinical Trial Details – MAS825/Novartis Pharmaceuticals
Table 2.19 Clinical Trial Details – Orismilast/Gregor Jemec
Table 2.20 Clinical Trial Details – PTM-001/Phoenicis Therapeutics
Table 2.21 Clinical Trial Details – RIST4721/Aristea Therapeutics Inc
Table 2.22 Clinical Trial Details – Ruxolitinib/Incyte Corporation
Table 2.23 Clinical Trial Details – Sonelokimab/MoonLake Immunotherapeutics AG
Table 2.24 Clinical Trial Details – Spesolimab/Boehringer Ingelheim
Table 2.25 Clinical Trial Details – Upadacitinib/AbbVie
Table 2.26 Clinical Trial Details – AT193/Azora Therapeutics Australia Pty Ltd
Table 2.27 Clinical Trial Details – CSL324/CSL Behring
Table 2.28 Clinical Trial Details – KT-474/Kymera Therapeutics Inc
Table 3.1 Regulatory Designations
Table 4.1 Inactive Drugs
Table 4.2 Discontinued Drugs
List of Figures
Figure 1.1 Number of Products under Development for Hidradenitis Suppurativa, 2023
Figure 1.2 Products by Top 5 Targets and Stage of Development for Hidradenitis Suppurativa, 2023
Figure 1.3 Products by Top 5 Mechanism of Action for Hidradenitis Suppurativa, 2023
Figure 1.4 Products by Top 5 Molecule Type for Hidradenitis Suppurativa, 2023
Figure 1.5 Products by Top 5 Route of Administration for Hidradenitis Suppurativa, 2023
Key Players
- AbbVie
- Acelyrin Inc
- Aclaris Therapeutics Inc
- Afecta Pharmaceuticals Inc
- Amgen
- Aristea Therapeutics Inc
- Azora Therapeutics Australia Pty Ltd
- Boehringer Ingelheim
- CSL Behring
- Eli Lilly and Company
- Gregor Jemec
- Henlez
- Incyte Corporation
- InflaRx GmbH
- Inmagene Biopharmaceuticals Ltd
- Janssen Research & Development LLC
- Kiniksa Pharmaceuticals Ltd
- Kymera Therapeutics Inc
- MoonLake Immunotherapeutics AG
- NovaRock Biotherapeutics Inc
- Novartis Pharmaceuticals
- Pfizer
- Pharma Holdings AS
- Phoenicis Therapeutics
- Regranion LLC
- Rigel Pharmaceuticals
- Staidson (Beijing) Biopharmaceuticals Co Ltd
- UCB Biopharma SRL
Report Segmentation
- Assessment by Stage of Development
- Assessment by Companies
- Assessment by Target
- Assessment by Mechanism of Action
- Assessment by Molecule Type
- Assessment by Route of Administration