Roche Launches Phase III Clinical Trial of ST2 Monoclonal Antibody Astegolimab in China, Targeting the Multi-Billion-Dollar COPD Market

On September 27, according to the Insight database, Roche's Astegolimab initiated Phase III clinical trials in China.ARNASA Research, TargetingChronic Obstructive Pulmonary Disease (COPD）(Registration No.:CTR20233027）。This is also the first clinical trial launched in China.

Source: Insight Database Web Version (Unless otherwise specified, the following content is from the same source)

According to the Insight database, Roche registered and initiated the ARNASA study (Registration No.: ) on the ClinicalTrials.gov platform as early as October 2022.NCT05595642), this launch is for the part in China. Globally, the study plans to enroll 1,290 participants, including 150 in China, and the first participant globally was successfully enrolled in December 2022. The relevant clinical data results are expected to be available by 2025.

ARNASA Research History Timeline

Astegolimab（RG-6149/ Astegolimab) is a personHumanized IgG2 monoclonal antibody that blocks the IL-33 signaling pathway by targeting the IL-33 receptor ST2.

From:Roche Official Website Information

Previously, the results of the Phase IIa COPD-ST2OP study showed that, compared with placebo, Astegolimab improved the condition of patients with moderate to severe COPD.

IIa Period COPD-ST2OPResearchResults

Source: Roche Official Website Materials

For Chronic Obstructive Pulmonary DiseaseDisease, exceptARNASA Research,Astegolimab is also conducting another global pivotalPhase IIb ALIENTO Study(Registration Number:NCT05037929），The trial designs of both are similar and are also expected to be completed in 2025.

Source: Roche Official Website Materials

In addition, Roche has just launched aPhase IIISingle-arm, open-label extension study (Registration number:NCT05878769), to evaluate the long-term safety of Astegolimab in patients participating in the aforementioned two studies. The expected enrollment is 2000 participants, and the first subject was successfully enrolled in June this year.

NCT05878769 Trial Historical Timeline

Roche's Astegolimab Targets All COPD Patients.

Source: Roche Official Website Materials

According to WHO data, COPD is the third leading cause of death globally, resulting in 3.23 million deaths in 2019. According to Research Nester's forecast, the global COPD treatment market is expected to reach USD 30 billion by 2031. Although the market prospects are promising,However, the previous failures of biologics with different mechanisms in the COPD field have also deterred many companies.

Currently, globally, according to the Insight database,Only 3 ST2 monoclonal antibodies have entered the clinical stage,GSK's Melrilimab was previously discontinued from development.

Global Entry into Clinical Stage ST2 Monoclonal Antibody

Roche's Astegolimab is the furthest along in development, additionally, the layout includesZhengda TianqingAndMabwell。

The three have differences in the indications currently under development. Roche and Mabwell Bio are actively advancing the clinical development progress for COPD.RocheAstegolimab COPD Indication is Undergoing Multiple Phase III Clinical Trials, is expected to become the first ST2 monoclonal antibody for the treatment of COPD.Maiwei BioThing9MW1911 Just in February this year, the I/II phase clinical trial for COPD was initiated.Zhengda TianqingTQC2938 Just atIn March this year, the clinical trial was initiated in China for the first time (Registration No.:CTR20230916), for the indication of asthma.

However, for the asthma indication, the development path may be more challenging.

Melrilimab (GSK3772847), which GSK introduced from Johnson & Johnson in 2016, is a candidate drug for asthma. However, a severe adverse event of serious cellulitis was reported in the first-in-human clinical study of Melrilimab for asthma and atopic dermatitis. In Q3 2020, GSK removed it from their pipeline.

Astegolimab had previously been studied for asthma, but in February 2021, Roche removed this indication from its pipeline.

END

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