The Rise of Muscle-Building Therapies: A Promising Frontier in Biotechnology

As Eli Lilly, the leading pharmaceutical company globally, continues to make strategic moves in the field, it serves as a crucial benchmark for international mapping and offers valuable insights into the commercialization direction of biotechnology.

Acquisition of Versanis and the Pursuit of Bimagrumab:

In a significant move, Eli Lilly acquired Versanis for $1.925 billion in July this year, with the primary objective of obtaining the muscle-building and fat-reducing drug, bimagrumab.

Bimagrumab is a monoclonal antibody that targets and activates the type 2 receptor of myostatin, known as ActRII. ActRII is expressed in both fat and muscle cells and its activation leads to muscle atrophy and fat accumulation. Thus, targeting this pathway holds promise for driving fat loss while increasing muscle composition in patients.

Clinical Trials and Results:

In a 48-week Phase 2 clinical trial involving overweight or obese patients with type 2 diabetes, bimagrumab demonstrated significant results. Compared to the placebo, it caused approximately 22% loss in fat mass and a 4.5% increase in lean body mass. Unlike many incretin-based therapies, patients did not experience weight gain within 12 weeks after discontinuing the treatment. Current safety data for bimagrumab indicates mild side effects such as muscle cramps and diarrhea, primarily occurring in the early stages of treatment.

Synergy with GLP-1 and Future Prospects:

Muscle-building therapies are expected to be used in conjunction with GLP-1. Bimagrumab is currently undergoing a Phase IIb BELIEVE study to evaluate its effects as a monotherapy or in combination with semaglutide, a GLP-1 receptor agonist, in overweight or obese adults after 48 weeks of treatment.

Bimagrumab's journey began in 2014 when it was initially developed by Novartis. It was a collaborative effort between Dr. Lv Xiangyang, the founder of Laike Pharmaceutical, during his tenure at Novartis.

Limited Domestic Presence and Potential Catalysts:

Currently, apart from bimagrumab, Laike Pharmaceutical's LAE-102 is the only global ActRII monoclonal antibody entering clinical stages. It received FDA clinical trial approval in May this year. LAE-102 represents a next-generation fat-reducing and muscle-building drug, acting as an ActRIIA monoclonal antibody with regulatory effects on tumor growth, immune activation, muscle regeneration, and hematopoietic development.

Changchun High-Tech is expected to initiate U.S. clinical trials for its next-generation long-acting product targeting muscle growth by the end of 2024. This will gradually build a pipeline focused on muscle-building and fat-reducing, centered around long-acting growth hormone. It is hoped that the relevant indications will enter clinical stages swiftly.

The global landscape for muscle-building therapies is rapidly evolving. Close attention should be paid to the catalysts introduced by domestic pharmaceutical companies.

Italian start-up company Resalis's lead project RES-010, an antisense oligonucleotide (ASO) therapy inhibiting miR-22 microRNA, has demonstrated loss of fat storage without affecting muscle mass in preclinical studies. Resalis plans to initiate human clinical trials for RES-010 in early 2024.

APH-012, a lead project developed by Swiss start-up AphaiaPharma, is an oral microsphere that belongs to natural fat-reducing therapy, aiming to minimize side effects.

Even without considering its synergistic effect with GLP-1, the demand for anti-aging treatments targeting muscle atrophy in the elderly and the consumer demand for body shaping make muscle-building a potentially enormous market, comparable to weight loss.

The rise of muscle-building therapies, exemplified by Eli Lilly's strategic acquisitions and developments, represents a promising frontier in biotechnology. With the pursuit of bimagrumab and the potential of other muscle-building drugs, both domestically and internationally, this field holds significant potential for addressing muscle atrophy, fat loss, and consumer demands for body shaping. Continued research and clinical trials will further advance the development and commercialization of these therapies, offering new avenues for patients and the healthcare industry.