Therapeutic Class Overview: Psoriasis – Plaque Psoriasis & Psoriatic Arthritis: Novel Oral Drugs and Biologics to Change Future Treatment Paradigm
Over the last decades, therapeutic options for Plaque Psoriasis (PsO) and Psoriatic Arthritis (PsA) have expanded considerably and improved patients’ pain, function, and quality of life. Approved biologics fill in a critical unmet need of limited efficacy of DMARDs; however, as in most cases one drug does not fit the bill for all the patients. The lack of targeted immune therapies other than TNF-α inhibitors in Psoriasis signals opportunities for drug developers to bring agents to market that offer treatment alternatives (Anti-IL-17, IL-13, JAK, PDE4 inhibitors, etc). Pfizer launched the first oral Rheumatoid Arthritis (RA) drug –Xeljanz (tofacitinib/ CP-690,550, JAK 1/3 inhibitor) in 2012 for pts with moderately to severely active RA who are inadequate responder or intolerant to Methotrexate (MTX) at a price almost at par with biologics. In the last couple of years, the face of healthcare has been changing due to challenges – quality and its affordability and accessibility to the providers and patients. We believe there is an ample room for an efficacious affordable therapy to tap the mild to moderate RA pts population where biologics have not made a dent and expect few potential launches in 2014-15 (OTEZLA – apremilast, Xeljanz – tofacitinib) and onwards. In this report, we highlight the novel targets – oral, injectables, and topical drugs in the pipeline for the treatment of Psoriasis, compare their clinical trials data, and their commercial potential!
1. EXECUTIVE SUMMARY
2. UNMET NEED IN PSORIASIS
1. Limitations of Anti-TNFs
2. Scope for Entrants with Better Efcacy and Safety Proles
3. SPECIC UNMET NEED AND EMERGING THERAPIES
1. Plaque Psoriasis
2. Psoriatic Arthritis
4. PIPELINE – BIOLOGICS PRODUCTS
1. IL-12 and IL-23 inhibitors
1. Stelara
2. tildrakizumab (MK-3222/ SCH 900222)
3. Guselkumab (CNTO 1959)
4. Fezakinumab (ILV-094)
2. Interleukin-17 (IL-17) and Receptor (IL-17RA)
1. Secukinumab
2. Ixekizumab (LY2439821)
3. Brodalumab (AMG 827)
3. Other Targets
1. Cimzia
2. Itolizumab
3. Tregalizumab
5. PIPELINE – ORAL TREATMENT
1. Targeting JAK-STATs
1. Tofacitinib
2. LY3009104
3. INCB39110
4. ASP015K
5. GSK2586184
2. Phosphodiesterases 4 (PDE4) Inhibitor
1. OTEZLA
3. Other Targets
1. Sotrastaurin
2. LAS41008
3. Voclosporin
4. LLL 3348
5. CF101
6. Ponesimod
7. VB-201
8. FP187
9. GSK-2245840
10. IMO-8400
6. PIPELINE – TOPICAL TREATMENTS
1. M518101
2. CT327
3. DRM02
4. Xantryl
5. INCB18424
6. AN2728
7. MOL4249
8. DLX105
7. COMMERCIAL OUTLOOK
8. DISEASE OVERVIEW
1. Etiology and Pathophysiology of Psoriasis
2. Types of Psoriasis
3. Treatment Efcacy Tools
9. CURRENT TREATMENT OPTIONS
10. TREATMENT GUIDELINES FOR PSA
2. UNMET NEED IN PSORIASIS
1. Limitations of Anti-TNFs
2. Scope for Entrants with Better Efcacy and Safety Proles
3. SPECIC UNMET NEED AND EMERGING THERAPIES
1. Plaque Psoriasis
2. Psoriatic Arthritis
4. PIPELINE – BIOLOGICS PRODUCTS
1. IL-12 and IL-23 inhibitors
1. Stelara
2. tildrakizumab (MK-3222/ SCH 900222)
3. Guselkumab (CNTO 1959)
4. Fezakinumab (ILV-094)
2. Interleukin-17 (IL-17) and Receptor (IL-17RA)
1. Secukinumab
2. Ixekizumab (LY2439821)
3. Brodalumab (AMG 827)
3. Other Targets
1. Cimzia
2. Itolizumab
3. Tregalizumab
5. PIPELINE – ORAL TREATMENT
1. Targeting JAK-STATs
1. Tofacitinib
2. LY3009104
3. INCB39110
4. ASP015K
5. GSK2586184
2. Phosphodiesterases 4 (PDE4) Inhibitor
1. OTEZLA
3. Other Targets
1. Sotrastaurin
2. LAS41008
3. Voclosporin
4. LLL 3348
5. CF101
6. Ponesimod
7. VB-201
8. FP187
9. GSK-2245840
10. IMO-8400
6. PIPELINE – TOPICAL TREATMENTS
1. M518101
2. CT327
3. DRM02
4. Xantryl
5. INCB18424
6. AN2728
7. MOL4249
8. DLX105
7. COMMERCIAL OUTLOOK
8. DISEASE OVERVIEW
1. Etiology and Pathophysiology of Psoriasis
2. Types of Psoriasis
3. Treatment Efcacy Tools
9. CURRENT TREATMENT OPTIONS
10. TREATMENT GUIDELINES FOR PSA
LIST OF TABLES
1 Approved/ Marketed Products
2 A. Psoriasis’ Pipeline: Small Molecules – Oral/ Injectable B. Psoriasis’ Pipeline: Topical
3 Psoriasis’ Pipeline: Biologics
4 Select Late- & Mid-Stage Pipeline: Plaque Psoriasis
5 Select Late- & Mid-Stage Pipeline: Psoriatic Arthritis
6 Ixekizumab: Phase III Clinical Trial Designs
7 Brodalumab: Phase III Clinical Trial Designs
8 Clinical Data Comparison: Plaque Psoriasis – Biologics
9 A. Tofacitinib: PASI Improvement from Baseline B. Tofacitinib: Improvement in Quality-of-Life (QOL) Measures
10 Other Targets in Clinical Development for RA
11 Genes Associated with Psoriasis Susceptibility
12 Competitive Landscape: Plaque Psoriasis
13 Competitive Landscape: Psoriatic Arthritis
1 PFE’s Xeljanz Launch vs. Other Recent RA Launches 3
2 The Structure and Function of the Cytokines IL-12 And IL-23
3 Clinical Data: ACCEPT – Head-To-Head Trial with Enbrel
4 MK-3222Neutralizes IL-23, Specically
5 Immunology and Immunotherapeutic Targets of Psoriasis
6 IL-17-Induced Signaling Pathways
7 Ixekizumab: Clinical Response (PASI And sPGA) @ week
8 Itolizumab Value Proposition with Marketed Products
9 Regulation of JAK–STAT Signaling
10 INCB39110: Response Rate - Exploratory Efcacy Analyses
11 ASP015K – Changes from Baseline in PASI at Day 42
12 PDE Inhibitors Crosstalk
13 AEB071 – PASI 75 Reductions Compared with Baseline
14 DRM02– Novel Mechanism of Action
15 DLX105 – PhIa Results (PASI Changes @ Day 14)
16 Psoriasis Treatment Ladder (Schematic)
17 US Psoriasis Market Estimation
18 Proposed Schema of the Evolution of A Psoriatic Lesion
19 Distribution of Psoriasis Severity
20 Use of Therapies Depending on the Disease Severity
21 Targeted Therapy Classication Based on Pathogenesis
22 Comparison of GRAPPA and AAD Treatment Guidelines
1 Approved/ Marketed Products
2 A. Psoriasis’ Pipeline: Small Molecules – Oral/ Injectable B. Psoriasis’ Pipeline: Topical
3 Psoriasis’ Pipeline: Biologics
4 Select Late- & Mid-Stage Pipeline: Plaque Psoriasis
5 Select Late- & Mid-Stage Pipeline: Psoriatic Arthritis
6 Ixekizumab: Phase III Clinical Trial Designs
7 Brodalumab: Phase III Clinical Trial Designs
8 Clinical Data Comparison: Plaque Psoriasis – Biologics
9 A. Tofacitinib: PASI Improvement from Baseline B. Tofacitinib: Improvement in Quality-of-Life (QOL) Measures
10 Other Targets in Clinical Development for RA
11 Genes Associated with Psoriasis Susceptibility
12 Competitive Landscape: Plaque Psoriasis
13 Competitive Landscape: Psoriatic Arthritis
1 PFE’s Xeljanz Launch vs. Other Recent RA Launches 3
2 The Structure and Function of the Cytokines IL-12 And IL-23
3 Clinical Data: ACCEPT – Head-To-Head Trial with Enbrel
4 MK-3222Neutralizes IL-23, Specically
5 Immunology and Immunotherapeutic Targets of Psoriasis
6 IL-17-Induced Signaling Pathways
7 Ixekizumab: Clinical Response (PASI And sPGA) @ week
8 Itolizumab Value Proposition with Marketed Products
9 Regulation of JAK–STAT Signaling
10 INCB39110: Response Rate - Exploratory Efcacy Analyses
11 ASP015K – Changes from Baseline in PASI at Day 42
12 PDE Inhibitors Crosstalk
13 AEB071 – PASI 75 Reductions Compared with Baseline
14 DRM02– Novel Mechanism of Action
15 DLX105 – PhIa Results (PASI Changes @ Day 14)
16 Psoriasis Treatment Ladder (Schematic)
17 US Psoriasis Market Estimation
18 Proposed Schema of the Evolution of A Psoriatic Lesion
19 Distribution of Psoriasis Severity
20 Use of Therapies Depending on the Disease Severity
21 Targeted Therapy Classication Based on Pathogenesis
22 Comparison of GRAPPA and AAD Treatment Guidelines
LIST OF FIGURES
1 PFE’s Xeljanz Launch vs. Other Recent RA Launches
2 The Structure and Function of the Cytokines IL-12 And IL-23
3 Clinical Data: ACCEPT – Head-To-Head Trial with Enbrel
4 MK-3222Neutralizes IL-23, Specically
5 Immunology and Immunotherapeutic Targets of Psoriasis
6 IL-17-Induced Signaling Pathways
7 Ixekizumab: Clinical Response (PASI And sPGA) @ week 20
8 Itolizumab Value Proposition with Marketed Products
9 Regulation of JAK–STAT Signaling
10 INCB39110: Response Rate - Exploratory Efcacy Analyses
11 ASP015K – Changes from Baseline in PASI at Day 42
12 PDE Inhibitors Crosstalk
13 AEB071 – PASI 75 Reductions Compared with Baseline
14 DRM02– Novel Mechanism of Action
15 DLX105 – PhIa Results (PASI Changes @ Day 14)
16 Psoriasis Treatment Ladder (Schematic)
17 US Psoriasis Market Estimation
18 Proposed Schema of the Evolution of A Psoriatic Lesion
19 Distribution of Psoriasis Severity
20 Use of Therapies Depending on the Disease Severity
21 Targeted Therapy Classication Based on Pathogenesis
22 Comparison of GRAPPA and AAD Treatment Guidelines
1 PFE’s Xeljanz Launch vs. Other Recent RA Launches
2 The Structure and Function of the Cytokines IL-12 And IL-23
3 Clinical Data: ACCEPT – Head-To-Head Trial with Enbrel
4 MK-3222Neutralizes IL-23, Specically
5 Immunology and Immunotherapeutic Targets of Psoriasis
6 IL-17-Induced Signaling Pathways
7 Ixekizumab: Clinical Response (PASI And sPGA) @ week 20
8 Itolizumab Value Proposition with Marketed Products
9 Regulation of JAK–STAT Signaling
10 INCB39110: Response Rate - Exploratory Efcacy Analyses
11 ASP015K – Changes from Baseline in PASI at Day 42
12 PDE Inhibitors Crosstalk
13 AEB071 – PASI 75 Reductions Compared with Baseline
14 DRM02– Novel Mechanism of Action
15 DLX105 – PhIa Results (PASI Changes @ Day 14)
16 Psoriasis Treatment Ladder (Schematic)
17 US Psoriasis Market Estimation
18 Proposed Schema of the Evolution of A Psoriatic Lesion
19 Distribution of Psoriasis Severity
20 Use of Therapies Depending on the Disease Severity
21 Targeted Therapy Classication Based on Pathogenesis
22 Comparison of GRAPPA and AAD Treatment Guidelines
