After recently initiating its first Phase II trial in obesity, Kallyope plans to expand its future clinical trials in metabolic disorders to international sites, chief medical officer Dr Brett Lauring told Clinical Trials Arena.

Last month, the US-based biotech started a Phase II trial investigating K-757 and K-833, new oral nutrient receptor agonists. The trial will recruit 150 patients with obesity to evaluate K-757 as a monotherapy and in combination with K-833.

While the ongoing Phase II trial is only based in the US, the next round of studies is likely to open international sites. The biotech plans to conduct Phase IIb dose range finding trials in obesity and type 2 diabetes, Lauring shared.

Although Lauring did not share the approximate initiation dates for upcoming trials, he said that data from the ongoing Phase II trial will inform the next steps for the biotech. The company will evaluate how the single agent and combination treatment perform, which will lead to the exact composition of doses and dose arms in the next trials.

Lauring noted that data readout from the Phase II trial is expected next year. According to the registry, the estimated trial (NCT06019559) completion date is July 2024. The primary endpoint of the study is measuring the percentage change in body weight after 12 weeks of treatment.

Last year, Kallyope raised $236m in a Series D funding round to develop gut-brain axis treatment programmes.

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Entering a crowded obesity market

Over the past few years, the obesity space has become very active, with GLP-1 receptor agonists claiming the limelight. However, Lauring noted that obesity is a significant unmet need with fewer than 2% of patients seeking and receiving any medical treatment.

In the existing landscape, most of the currently approved high-efficacy and safe agents are injectables.  Additionally, they are peptides that are expensive and difficult to manufacture at scale. He said: “There is going to be a huge place for oral therapies that are going to be scalable, and really meet the demand.”

Recently, many patients reported severe side effects after using some of the approved weight loss drugs. Both the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) launched investigations into reported suicidal ideation in patients after using Novo Nordisk’s GLP-1 assets.

Kallyope is not concerned that its drugs will affect the mood due to a different mechanism, Lauring explained. Additionally, the drugs are designed to act primarily in the gut and to have low plasma exposure.

He added: “We are not worried about any specific psychiatric adverse events based on the mechanism of action and current profile of our drugs.”