100 billion IBD market, blow the trumpet

In Roman mythology, Prometheus represents hope; he created man with Athena, the goddess of wisdom, and rebelled against Zeus, bringing fire to earth.

Now we have Prometheus, which pioneered innovation.

IBD (inflammatory bowel disease) has long had a large population of patients, but there is no cure for it. In this context, pharmaceutical companies continue to push forward the battle, in order to bring better treatment options for patients, to meet the huge unmet clinical needs.

Prometheus also targeted this area with its TL1A antibody, which is emerging as a promising treatment for IBD. Thanks to this, Prometheus was acquired by Merck for $10.8 billion.

Prometheus was not, of course, the terminator in IBD. But the story of Prometheus's riches will also inspire the drug companies in their efforts to solve the problem.

01
IBD precision Medicine has a market size of 18 billion dollars

IBD patients look forward to Prometheus.

IBD is a chronic disease of the gastrointestinal tract, including Crohn's disease and ulcerative enteritis. The common symptoms are severe diarrhea, fatigue, etc., which greatly affects the quality of life of patients and requires effective continuous treatment.

More importantly, the impact of IBD is widespread. According to Prometheus reports, IBD has affected more than 2 million people in the U.S. and 5 million worldwide.

Unfortunately, due to the complex etiology of IBD, the pathogenesis has not been clearly studied, which leads to the lack of effective cure for the disease.

Although biologic therapy represented by adamumab has become a new treatment option for IBD patients since the end of last century, it has improved the quality of life of patients to a large extent, but it is still far from enough:

About a third of patients do not respond to biologic therapy; About half of those who respond to initial treatment develop a "secondary loss of response," similar to "resistance" to antibiotics.

Today, the market for IBDs is about $18 billion globally and is expected to grow to about $49 billion globally by 2030. The IBD market is highly concentrated, with four therapeutic products, including adalimumab, accounting for 75% of global revenues.

The large unmet clinical need underscores the importance of continuing to develop new therapies for IBD. Prometheus saw this opportunity and bet on it.

Currently, the core pipeline of Prometheus is a TL1A antibody that regulates both inflammatory and fibrotic pathways for therapeutic purposes.

Pfizer has been a pioneer in this area. Prometheus, however, made improvements. According to Prometheus, the PRA023 was designed with superior combination marking and more effective reduction of off-target effects.

Prometheus continued to gain capital recognition and was sold to Merck for $10.8 billion based on excellent Phase 2 clinical data from PRA023.

02
Efficacy and safety, the key to stand out

Referring to PRA023, what are the advantages of an ideal treatment for IBD patients?

The answer is efficacy and safety. As mentioned above, the difficulty of treating IBD is that the efficacy is insufficient or not lasting; As for security, its importance in the field of self-avoidance is self-evident.

PRA023 is also recognized by the market based on its efficacy and safety.

In terms of efficacy, PRA023 has shown the same potential as existing therapeutic agents in both patients with ulcerative colitis and Crohn's disease.

For example, in a Phase 2 trial of Crohn's patients, about 49.1 percent achieved clinical remission. Remember, most of the patients enrolled in this study were highly treatable patients:

70.9% of the patients had received at least one biologic therapy and 52.7% had received two or more biologic therapies.

But even so, the benefits, or not less than similar drugs.

As a comparison, Abbvie's Upatinib, a relatively potent JAK inhibitor in the field of IBD, achieved clinical remission at 12 weeks in 40 percent and 51 percent of patients treated with 45mg of upatinib in two induction studies.

Of course, this does not mean that PRA023 can surpass Upatinib. In terms of the more rigorous endoscopic response measures, 26% of patients treated with PRA023 achieved an endoscopic response at week 12, while 35% and 46% of patients treated with 45mg of upatinib achieved an endoscopic response at week 12.

However, in terms of security, PRA023 is definitely superior. Prometheus has published phase 2 clinical data showing no serious adverse events at any dose, which is rare.

And Upatinib, known as "can hit," is a safety hazard, and the FDA issued a "black box warning" :

Not only are they required to be used only in patients who cannot tolerate or respond poorly to TNF inhibitors, they even remind patients that JAK inhibitors may increase the risk of heart disease, cancer, blood clots and death when treating certain inflammatory diseases.

But even so, Upatinib is still highly anticipated. Given this, it's not hard to see why Prometheus's stock price rose after the release of Phase 2 clinical data.

03
Big data wins, Accurate era of drug research and Development?

Merck's $10.8 billion acquisition of Prometheus is destined to be one of the landmark developments in the medical world's conquest of IBD.

This battle for IBD is far from the end, and domestic enterprises are not absent from this battle. Currently, pharmaceutical companies including Yahong Pharmaceutical, Borui Bio, and Sozhi Bio have entered the game.

But here's where the future of IBD therapy is headed. Efficacy and safety are known directions; what is not known is how to get there.

Prometheus spawned another idea: precision medicine.

Currently, IBD is treated with a "one size fits all" approach, regardless of the patient's genetic or biological differences.

Prometheus believed that a paradigm shift was required to develop specific therapies for patients whose diseases were biologically driven; that is, to classify patients for their different biological differences, etc., and to make large groups smaller.

For this purpose, Prometheus360TM was created for the development of precision therapy drugs. This also means that the IBD debate will move from the target R&D debate to the big data debate.

As can be seen, the core function of Prometheus360TM is to accumulate comprehensive clinical data and biological samples. According to Prometheus. This is one of the largest collections of biological specimens from patients with IBD and other gastrointestinal diseases in the world, and it will not be accumulated and expanded in the future.

Ultimately, based on these algorithms, drugs can be developed and specific patient groups can be identified, leading to better treatment outcomes. Prometheus has analyzed this data in its APOLLO-CD clinic for further precision medicine development.

So, 100 billion IBD market, who is in charge of the ups and downs? Let's move on.