Lilly Acquires Morphic Therapeutic for $3.2 Billion to Bolster Autoimmune Pipeline with Oral α4β7 Inhibitor MORF-057

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Only one clinical-stage product under development

According to the introduction on Morphic's official website, the company has multiple candidate products, involving indications including autoimmune diseases, pulmonary arterial hypertension, and the oncology field.

But only one, MORF-057, has actually entered the clinical stage.Which is the main value core of this $3.2 billion transaction.

This drug is aOral small molecule α4β7 inhibitor,CurrentlyMoMorphic Therapeutic is conducting two Phase II clinical trials for the two major indications: ulcerative colitis (UC) and Crohn's disease (CD).

According to the previously announced MORF-057, usingResults of the Phase IIa EMERALD-1 Trial for UC ShowAfter 12 weeks of treatment with 100mg BID, the primary endpoint RHI score was observed in 35 patients with moderate to severe UC.(Robarts Pathology Index, used to measure histological disease activity in ulcerative colitis)Significantly reduced by 6.4 points from baseline (p=0.002).

Secondary EndpointPatientThe mMCS ofModified Mayo Endoscopic ScoreAlso reduced from the baseline2.3 percentage points, while the mMCS remission rate and response rate are approximately 26% and 46%, respectively.

In this trial，MORF-057Well tolerated, no serious adverse events (SAEs) or safety signals were observed. The most common adverse events were UC exacerbation and anemia.

Such safety,Or more effective than JAK1 inhibitors (such as AbbVie's Upadacitinib)）Drugs have a larger therapeutic window.

But it can't be compared like this, the sameUC Field，The market often associates it with Takeda Pharmaceutical'sDrugs with the Same TargetEntyvio对标。(Actually,Morphic often refers to itself as the "oral versionEntyvio”）

Entyvio is Takeda'sSales Pillar,Total sales for the full year of 2023 reached 800.9 billion yen (over 50 billion US dollars), a solid blockbuster. In comparison,MORF-057 as an oral formulation must be superior toEntyvio SuchSubcutaneous injection/Intravenous infusion formulation.

It seems that MORF-057 will have broader market prospects, but in fact, it won't—at least not for now.。

Uncertainty of MORF-057

First isEMERALD-1The trial did not include a control group,How credible is the primary endpoint?Secondly, taking a step back, even if the data is credible,The primary endpoint was not met either.Phase III Clinical Results of Entyvio - 7.5.(Belongs to the cross-comparison of efficacy, with inconsistent drug dosage and duration)

In terms of market competition, the old drug king Humira,Entyvio, Upadacitinib, etc. are重磅单品 for UC/CD in various targets, with high market share.

In terms of R&D landscape, just a month ago (June 27, 2024), a pharmaceutical company named Ensho Therapeutics had just licensed an oral α4β7 inhibitor, AJM300, from Eisai. Currently, the drug has been approved in Japan for the induction treatment of UC.

Not only that,June 2023,Eli LillyAcquired Dice Therapeutics for $2.4 billion, thereby obtaining aPreclinical Oral α4β7 Program.

Moreover, Eli Lilly's own IL-23 antibody Mirikizumab was approved by the FDA last year for use in adult patients with moderate to severe UC. Mirikizumab has been approved for both intravenous and subcutaneous injection formulations.

NowadaysIt has been only a year.Eli Lilly and Company is willingInvests $3.2 Billion Again in Oral TherapeuticsThe value of the α4β7 project is evident.

MNC's New Favorite: IBD Field

Inflammatory Bowel Disease (IBD) is a chronic recurrent intestinal inflammatory disease, including UC and CD. Due to the attributes of being "incurable," "requiring long-term medication," and "prone to recurrence," the market is continuously expanding.

According to statistics, the global IBD market is approximately $18 billion, and it is expected to grow to about $49 billion by 2030. Meanwhile, the IBD market is relatively concentrated, with four treatment products, including Humira, accounting for 75% of global revenue.

Therefore, besides Eli Lilly and Company, many other MNCs are also involved.

April 2023,Merck Spends $10.8 Billion to Acquire Prometheus,Obtained TL1A monoclonal antibody MK-7240; in the same year,Roche Spends $7.1 Billion to Acquire Telavant,Thereby obtaining TL1A monoclonal antibody RVT-3101……

Shifting focus to China, the number of innovative IBD drugs currently in clinical development within the country is relatively low. Among them, Etrasimod (Itrumod), an oral S1P receptor modulator co-developed by Pfizer and Everest Medicines, and Hengrui Medicine/Arcutis's JAK1 inhibitor Ivarmacitinib, are the frontrunners in terms of development progress.

In the future, will there be transactions in China's IBD market? PharmaTimes will continue to monitor.

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