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Index Pharmaceutical and Ulcerative Colitis

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THE UC marketed drugs and the pipeline in phase 2 and 3 is presented below. Believe it is complete.

The same day we published our last issue on InDex Pharmaceuticals there were news on the Mirikizumab trail in ulcerative colitis. It was anoying, and triggered us to make a new analysis of the competitive landscape of the global UC landscape. It is a competetive landscape where InDex has a favourable position, now when starting a phase 3 study.

We have got several results over the last twelve months and can expect more going forward. Below is analysis of what has happened and what to expect.

Of course efficacy is important in this area, as in any disease but since UC is a chronic disease, the safety is also very important. InDex' Cobitolimod is completely outstanding. Even with a medium efficacy, Cobitolimod has the potential to reach an important position in the global UC market, especially in combo treatments or in scenarios where Cobitolimod is considered as 1st line therapy.

Evidence emerged a couple of days ago (March 18, 2021) to suggest that an era of regulatory permissiveness is ending in the US: the FDA seems to be taking a closer look at the safety of the Jak inhibitor class (Evaluate).

The market is today dominated by the old anti TNFa drugs Humira (Abbvie) and Remicade (J&J), both with several biosimilars in the market, but also by Pfizer's Jak-inhibitor Xeljenz and Takeda's Entyvio which is an integrin binding drug. All have more or less side effects but Xeljenz stands out with a black box warning. J&J do also have Simponi, another TNF-a drug and Stelara (IL12/IL23) in the market.

In the pipeline you can discover several Jak-inhibitors reaching final results the coming 24 months. Most talked about is Abbvie's Rinvoq for 2022 but also Galapagos/Gillead's Jysleca in Europe. The drug was refused by FDA in RA and the will test EMA in UC 

In the second half of 2021. We will see how EMA looks at the Jak-area considering the above implicated tougher stance from FDA.

Other mechanism of actions are pure IL-23 which seems to be more effective than Stelara which also targets IL-12 like mirikizumab does. The IL-23's in the late stage pipeline are mainly Skyrizi (Abbvie), Tremfya (J&J) and Brazikumab (AZ). Thecfirst two have phase 3 readous in 2022 while Brazikumab has phase 2 readout.

The most interesting readout during 2021 is Arena's ph 3 reporting on etrasimod late in the year. Phase 2 data where rather impressive. Furthermore, early 2022 EliLily is reporting on mirikuzumab in the full phase 3 study which reported its induction phase last week (above).

Other studies that have reported recently are BMS on ozanimode - data where mixed but they have a PDUFA date May 30, 2021 as a result of a priority voucher. Roche posted doubtful results on Etrolizumab which may be cancelled completely. Also Eisai/EaPharma reported on AMJ300 - results ere not impressive but an approval for Japan will be applied for.

During 2021 about ten companies will report on phase 2 data. The outcome of these studies will determine who will go on and follow into the footsteps of InDex into phase 3 soon to start.

The market and pipeline developments are extremely interesting to follow as well as the FDA vision on Jak-inhibitors. As stated above InDex has a very special position in the field. A higher dose i phase 3 (500 toghether with 250 mg from earlier) might increase the efficacy and also further prove the superior safety of Cobitolimod.

The company triggers that will/could come soon is

[ ] CRO agreement and final study design

[ ] Application In 30-40 countries

[ ] Start phase 3 early Q3

[ ] A project to develop the oral prototype version of Cobitolimod, both for UC but also for CD - Cronhs Disease which will dracticly enhance the pharma interest for Cobitolimod

Considering the very large market for UC Index has the potential to tap into large sales volumes going forward. That is not discounted by the stock market at all. Rather the opposite, it shows a lack of understanding of the large potential.


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