The US Food and Drug Administration (FDA) has granted clearance to Immunis to proceed with its Phase II clinical trial for IMMUNA, an investigational secretome aimed at reversing sarcopenic obesity.
The trial will assess the efficacy of IMMUNA in improving mobility and independence for individuals with this condition.
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This development follows the completion of Immunis’ Phase I/IIa trial for age-related muscle atrophy, which showed no adverse events and indicated enhanced muscle function.
Recently popularised for weight management, GLP-1 drugs have raised concerns due to their potential long-term effects, including muscle mass reduction, the company noted.
Scientific reports are claimed to have indicated that a significant portion of weight loss from these drugs is muscle, not fat, which could lead to increased health risks and healthcare costs.
In contrast, Immunis’ IMMUNA aims to reduce fat while preserving muscle mass.
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By GlobalDataThe company’s Phase I/IIa clinical trial results demonstrated no adverse events linked to the drug and indicated improved muscle function, as measured by the six-minute walk test.
Immunis’ preclinical data published this year also supports IMMUNA’s ability to increase lean mass, reduce fat mass, and enhance muscle size and function.
The company is developing IMMUNA as part of its product line focused on addressing age and disease-related immune decline.
Its secretome technology aims to deliver a natural and human-sourced product containing immune modulators at physiological concentrations.
Immunis chairman Dr Hans Keirstead said: “Our innovative therapy shows promising results by simultaneously decreasing fat and enhancing muscle and muscle function. We’re taking a significant stride towards improving healthspan.”
In June this year, Immunis partnered with Springbok Analytics to use Springbok’s technology to assess the efficacy of IMMUNA in restoring muscle growth and function.
