Istesso Begins Phase 2 Trial of Leramistat for Muscle Loss in Rheumatoid Arthritis Patients

Istesso Advances Lead Drug Candidate into Phase 2 Testing

IP Group plc has announced that its portfolio company, Istesso, has started dosing patients in a Phase 2 clinical trial evaluating leramistat for sarcopenia associated with rheumatoid arthritis.

The study, known as IST-03, marks an important step for the company as it moves forward with a new approach aimed at improving muscle health and tissue repair in people living with chronic disease.

Study Focuses on Muscle Quality and Function

The Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate how leramistat affects muscle quality, muscle repair, and overall muscle function.

Researchers are looking at whether the treatment can help address sarcopenia, a condition characterized by progressive muscle loss and weakness.

Sarcopenia is becoming a growing health concern worldwide, particularly among aging populations and people living with chronic illnesses. Despite its impact on mobility, independence, and quality of life, there are currently no approved drug therapies specifically developed to treat the condition.

Previous Research Supports Further Development

The new clinical trial is supported by earlier findings from rheumatoid arthritis studies involving leramistat.

In previous research, patients receiving leramistat experienced improvements in disability and fatigue, along with reductions in biological markers linked to muscle loss.

Preclinical studies also produced encouraging results. Researchers observed restoration of muscle quality in disease models and improvements in muscle mass, strength, and function in older animals. In some cases, these improvements exceeded levels seen in younger animals before treatment.

These findings provided the basis for advancing the therapy into Phase 2 evaluation.

Goal Is to Enhance the Body’s Natural Repair Mechanisms

According to the company, one of the key objectives of the IST-03 study is to determine whether leramistat can enhance the body's natural ability to repair damaged tissues.

If successful, the approach could have broader applications beyond muscle loss and potentially be used in other chronic degenerative and age-related diseases where tissue repair becomes less effective over time.

Leramistat Comes from a New Drug Class

Leramistat is the lead candidate from Istesso's proprietary class of compounds known as Mitochondrial Complex I Modulators (MCMs).

These compounds have demonstrated the ability to trigger adaptive tissue repair and regeneration across several tissues, including:

• Muscle

• Bone

• Lung

• Gastrointestinal tissue

The company believes this mechanism could offer a new way to address diseases driven by tissue degeneration rather than simply treating symptoms.

Patient Enrollment Underway in the United Kingdom

Enrollment for the IST-03 trial is currently taking place through a collaboration involving Newcastle University, Newcastle Hospitals, and the National Institute for Health and Care Research (NIHR).

The research centers bring specialized expertise in muscle biopsies, advanced imaging technologies, and tissue analysis methods that will help researchers assess the effects of the treatment in detail.

IP Group Highlights Potential of the Program

Greg Smith, Chief Executive of IP Group, described the start of the Phase 2 study as an important milestone for Istesso.

He noted that the company is advancing a novel regenerative medicine approach supported by both clinical and preclinical evidence. According to Smith, the ability to influence underlying tissue repair could create opportunities across multiple diseases where treatment options remain limited.

He added that positive results from the study would provide important validation for the company's scientific approach and could open the door to development programs in several large areas of unmet medical need.

IP Group Maintains Majority Stake in Istesso

IP Group currently holds an undiluted ownership stake of 56.5% in Istesso.

The progress of the IST-03 study represents a significant development for both companies as they continue to explore regenerative therapies designed to improve tissue repair, muscle health, and functional outcomes in patients affected by chronic and age-related diseases.

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