First Patient Dosed in Phase 2 Trial of Anti–IL-11 Antibody for Pathological Scarring

Mabwell recently announced that the first patient has been dosed in its phase 2 clinical trial evaluating its anti-IL-11 monoclonal antibody (9MW3811) for pathological scarring. 9MW3811 has become the first IL-11 targeting therapeutic evaluated in clinical trials for pathological scarring.¹

The phase 2 trial, CTR20254857, will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of 9MW3811 in patients with pathological scarring. The first patient was dosed at the Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. Previously, 9MW3811 had completed phase 1 trials in healthy subjects in Australia and China, with results demonstrating a positive safety profile and a half-life of more than one month.1

9MW3811 is designed to bind IL‑11 with high affinity and effectively inhibit abnormal activation of the IL‑11/IL‑11Rα signaling pathway. The inhibition has the potential to block the pathological progression of fibrosis‑related diseases.^1,2

According to Mabwell, key advantages of 9MW3811 include a higher target affinity and stronger signaling blockade, as well as its half-life data, which makes it suitable for chronic diseases requiring long-term treatment.²

Recent Data

Preclinical data suggest that 9MW3811 demonstrated robust antifibrotic activity across multiple disease models, including pulmonary fibrosis, with potential applicability in fibrosis-associated conditions relevant to dermatology, such as hypertrophic scarring. In human-derived keloid xenograft models, treatment with 9MW3811 was associated with attenuation of dermal fibrotic progression and a reduction in established scar volume.^1,2

The investigational agent has received regulatory clearance to initiate clinical development in China, the US, and Australia for indications including idiopathic pulmonary fibrosis and advanced malignancies, and has completed phase 1 studies in healthy volunteers in Australia and China.²

According to a 2024 study published in Nature, IL-11 is connected to aging-associated disease processes, including fibrotic and degenerative conditions. Mabwell has entered into an exclusive licensing agreement with CALICO Life Sciences for the development of 9MW3811. Beyond its potential role in multi-organ fibrotic disorders—including idiopathic pulmonary fibrosis, thyroid eye disease, and cutaneous fibrosis—9MW3811 is also being explored for broader applications in fibrosis affecting renal, hepatic, and cardiac tissues. Preclinical findings further suggest that IL-11 pathway modulation may have relevance in aging-associated conditions linked to cellular senescence, frailty, and longevity.³

About Pathological Scarring

Pathological scarring—including hypertrophic scars, keloids, and contracture scars—is driven by IL-11–mediated fibroblast-to-myofibroblast transdifferentiation, characterized by upregulation of extracellular matrix production and α–smooth muscle actin (α-SMA) expression. Mechanistic support for this pathway was demonstrated in a 2022 Journal of Investigative Dermatology study, which showed that CD39-expressing fibroblasts promote myofibroblast activation through enhanced IL-11 secretion in hypertrophic scar tissue.^2,4

In preclinical models, inhibition of IL-11 signaling was associated with a reduction in α-SMA–positive fibroblasts and attenuation of scar progression. From a population standpoint, Frost & Sullivan data estimates suggest that approximately 25 million patients worldwide are affected by pathological scarring, demonstrating the growing clinical and therapeutic relevance of antifibrotic targets in dermatology.⁴

References

1. Mabwell announces first patient dosed in phase II trial of anti-IL-11 antibody for pathological scarring. News release. Mabwell. December 29, 2025. Accessed January 2, 2026. https://www.mabwell.com/en/news_info/id-202.html
2. Mabwell's novel anti-IL-11 monoclonal antibody 9MW3811 approved by NMPA to initiate phase II clinical trial in pathological scarring. News release. Mabwell. https://www.mabwell.com/en/news_info/id-196.html
3. Widjaja AA, Lim WW, Viswanathan S, et al. Inhibition of IL-11 signalling extends mammalian healthspan and lifespan. Nature. 2024;632(8023):157-165. doi: 10.1038/s41586-024-07701-9
4. Huang X, Gu S, Liu C, et al. CD39+ fibroblasts enhance myofibroblast activation by promoting IL-11 Secretion in hypertrophic scars. J Invest Dermatol. 2022;142(4):1065-1076.e19. doi: 10.1016/j.jid.2021.07.181