The Commercial Impact Of The Ongoing Head-To-Head Trials On The Psoriasis Sector

Industry : Pharmaceuticals    

PASI, Psoriasis Area & Severity Index, is a measure of overall psoriasis severity and coverage of body surface area and erythema, sclerosis, and scaling. Although used rarely in clinical practice, PASI is a key metric used in clinical trials for psoriasis drugs. Companies typically show the proportion of patients reaching a pre-specified PASI reduction score in clinical trials, which is typically PASI75.

IL-17 and IL 23s are demonstrating the highest PASIs with almost 100% skin clearance, bringing strong excitement in the space. The psoriasis treatment market is becoming intensely competitive with more than 10 head-to-head trials ongoing among the key products. The head-to-head clinical trials aim at establishing superior efficacy through improved PASI scores to gain competitive advantage and clinical differentiation.

Cosentyx, the IL17A blocking antibody from Novartis, remains one of the leading drugs in the treatment of psoriasis and exhibits impressive safety and efficacy profile. In February 2018, landmark results from the Phase III SCULPTURE study demonstrated 100% maintenance in PASI 90 and PASI 100 scores at five years in patients with moderate-to-severe plaque psoriasis (PsO). Additionally, Novartis received a label expansion of Cosentyx that includes moderate-to-severe scalp psoriasis. The drug has also shown long-term efficacy in nail and palmoplantar psoriasis. Earlier in January 2018, the results from the Phase III CLARITY study reinforced Cosentyx’s superiority over J&J’s Stelara. The study supported superiority of Cosentyx against Stelara in achieving both primary (PASI 90 and IGA mod 2011 0/1) and secondary endpoints (PASI 100).

To expand sales and differentiate Cosentyx from other market leading and investigational late-stage treatments, Novartis is advancing several head-to-head trials. For example, a Phase III trial that compares AbbVie’s risankizumab with Cosentyx is under way, with results expected in June 2020. Risankizumab exhibits impressive efficacy data in three pivotal Phase III trials in comparison to Humira and Stelara and is expected to receive regulatory approval in 2019.

Eli Lilly’s late-stage pipeline asset mirikizumab is in a Phase III clinical trial against Cosentyx (OASIS-2) for moderate-to-severe PsO, with expected readout in 2020. Eli Lilly’s psoriasis franchise, driven by the rising uptake of Taltz, will gain additional ground if mirikizumab outperforms Cosentyx in clinical trials.

Tremfya, one of the newest product approvals for psoriasis by J&J, is under clinical investigation in three key late-stage trials against Humira (VOYAGE-2), Cosentyx (ECLIPSE), and Taltz (IXORA-R). Novartis is likely to initiate a proof of concept study (ARROW) to establish the superiority of IL-17 inhibition (with Cosentyx) over IL-23 inhibition (with Tremfya) in PsO patients who are resistant to Stelara. As Tremfya enters a crowded psoriasis market, there is a need to differentiate itself from other IL-inhibiting drugs. In the Phase III NAVIGATE trial, patients who failed to respond adequately to Stelara, showed improved results when they switched treatment to Tremfya. Further, Tremfya offers cost advantage to Cosentyx and Taltz. However, the commercial success of Tremfya will hinge on the Phase III ECLIPSE study (Tremefya vs Cosentyx) results expected to read out in late 2018.

UCB’s interleukin inhibitor, bimekizumab, is one of the most promising pipeline products in the psoriasis market. The drug has a dual neutralizing effect on IL-17A and IL-17F with meaningful clinical superiority over other marketed IL-inhibitors. Bimekizumab demonstrated remarkable safety and efficacy results in a Phase IIb study (BE ABLE), with 79% subjects attaining PASI 90 and nearly 60% patients achieving PASI 100 at week 12. The trial results are impressive, particularly PASI 100 response, when comparing bimekizumab’s 60% with Cosentyx’s 24-28%, and Taltz’s 35-39%. UCB has initiated head- to head trials with Cosentyx (BE RADIANT), Humira (BE SURE), and Stelara (BE VIVID). The commercial prospect of bimekizumab appears strong and we believe the product to be a game-changer in the psoriasis market.

Table 1 Psoriasis head-to-head trials: Events Calendar

Trial Subject

Sponsor

Indication

Phase

Trial Start Date

Estimated Trial Completion Date

Tremfya vs Cosentyx (ECLIPSE)

J&J

Moderate-to-severe plaque-type psoriasis

III

April 2017

September 2018

Cimzia vs Enbrel (CIMPACT)

UCB

Plaque psoriasis

III

February 2015

December 2018

Tremfya vs Taltz (IXORA-R)

Eli Lilly

Moderate-to-severe plaque psoriasis

IV

November 2018

December 2019

Bimekizumab vs Humira (BE SURE)

UCB

Moderate-to-severe plaque psoriasis

III

January 2018

March 2020

Bimekizumab vs Stelara (BE VIVID)

UCB

Moderate-to-severe plaque psoriasis

III

December 2017

March 2020

Mirikizumab vs Cosentyx (OASIS-2)

Eli Lilly

Moderate-to-severe plaque psoriasis

III

June 2018

April 2020

Risankizumab vs Cosentyx

AbbVie

Moderate-to-severe plaque psoriasis

III

May 2018

June 2020

Tremfya vs Humira (VOYAGE 2)

J&J

Moderate-to-severe plaque-type psoriasis

III

November 2014

July 2020

Bimekizumab vs Cosentyx (BE RADIANT)

UCB

Moderate-to-severe plaque psoriasis

III

June 2018

August 2020

Source: FDA, Investor Presentations, Grand View Research

The psoriasis market becomes increasingly crowded and competitive making efficacy and access the key determinant of success. As newer therapeutic agents demonstrate stronger efficacy, focus has now shifted to the higher PASI90 and PASI100 responses. Since efficacy remains high among most novel psoriasis drugs, differentiation becomes increasingly difficult. However, more than the PASI 90 or 100 rates, as the market becomes more crowded, we expect payer pressure will emerge and strong product uptakes will be supported by the ability of the manufacturer to negotiate with payer groups.

  In-depth report on global psoriasis drugs market by Grand View Research:

https://www.grandviewresearch.com/industry-analysis/psoriasis-drugs-market

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