Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt joined Proactive to discuss the company’s latest findings on IMU-856, a drug candidate initially studied for celiac disease.
New data suggests that IMU-856 significantly increases endogenous GLP-1 levels in a dose-dependent manner, which could make it a potential oral treatment for obesity.
Proactive: Hello, you're watching Proactive. I'm joined by Immunic CEO Dr Daniel Vitt. Daniel, very good to speak with you today. Earlier, you released an interesting update on your IMU-856 development program, potentially expanding its indications. Could you walk us through the update, please?
Dr Daniel Vitt: Yes, thank you. Good morning. This morning, we announced some interesting new data. As you may recall, the drug was tested in a clinical study in patients with celiac disease. Interestingly, we just found out that the drug has further pharmacological activity. Specifically, it impacts GLP-1 levels in patients, increasing endogenous GLP-1 in a dose-dependent manner. In fact, the highest dose tested—160 mg—achieved statistical significance after 29 days of treatment.
Could you tell us what GLP-1 actually is? What is its role and effect in the body?
GLP-1 is a hormone that occurs naturally in the gut. It is mainly released after eating and helps regulate blood sugar. It is part of the incretin hormone family, which you may be familiar with—there are hormone derivatives or drugs that mimic GLP-1, currently used as injectables for obesity treatment.
Could you provide more details on what you saw in the post hoc analysis of your Phase 1b clinical trial?
Of course. We had 11 patients on placebo, 13 patients on 80 mg, and 13 patients on 160 mg of IMU-856, treated for four weeks. We compared their baseline GLP-1 levels with data after two weeks and 29 days of treatment. Measurements were taken in the morning while fasting. We observed a dose-dependent and time-dependent increase in baseline GLP-1 levels, with up to a 250% increase in patients treated with 160 mg for four weeks.
It is important to note that these patients also received a gluten challenge after two weeks. Despite this, we still observed a significant increase in GLP-1 levels.
You also generated new preclinical data to support this rationale. Could you share the details with us?
Yes. This finding initially came from our chronic safety studies, where we treated rats for six months to monitor for any potential side effects. During these studies, we noticed a significant, dose-dependent reduction in weight gain.
In these preclinical studies, we started with juvenile animals and treated them for six months. We tested three different doses: 10 mg, 25 mg, and 75 mg per kilogram, compared with placebo. The results were remarkable—a 40% lower weight gain in the high-dose group, 23% in the 25 mg group, and 18% in the 10 mg group.
These findings align with the observed GLP-1 increase in human patients from our Phase 1 study. This suggests that IMU-856 may have a significant impact on GLP-1 and could potentially offer a new way to treat obesity.
Obesity is a huge market with millions of people affected worldwide. Daniel, which treatments are currently available, and what is the future market potential?
Currently, several treatments exist, mainly incretin mimetics—GLP-1 and GIP mimics—which are well-known injectable drugs. These are usually administered via subcutaneous injections.
The global obesity treatment market is expected to grow to $170 billion, according to recent analyses. This is a significant market because obesity has a major impact on healthcare systems. Patients need more treatment options.
IMU-856, based on our current data, could provide a novel mechanism of action in an oral form. This could make it easier for patients to use while maintaining an attractive safety profile. We believe IMU-856 could be a compelling new treatment option for obesity.
Quotes have been lightly edited for clarity and style