Swiss company Versameb will initiate a clinical trial investigating a messenger ribonucleic acid (mRNA) to treat stress urinary incontinence, after receiving clearance from the US Food and Drug Administration (FDA). 

The FDA approved the company’s investigational new drug (IND) application for a Phase IIa trial of VMB-100 – an intramuscularly locally delivered, sequence-engineered mRNA. 

The study is scheduled to start in the first half of 2024. 

Versameb’s candidate encodes human insulin-like growth factor-1 (IGF-1). According to Versameb, preclinical studies have shown that VMB-100 can induce the expression of IGF-1 in human muscle cells, and the candidate accelerated the regeneration of the urinary sphincter muscle and restored urinary sphincter function in animal models of stress urinary incontinence, after a single dose of treatment.  

Stress urinary incontinence is a condition where there is an involuntary leakage of urine due to a weakened urinary sphincter muscle. It is a condition that particularly affects females. There are currently no approved pharmacological therapies available in the US, with current standards of care involving short-term solutions such as pelvic floor therapy or invasive surgical procedures. 

In the announcement accompanying the IND approval, Versameb chief medical officer Roger Dmochowski said: “IGF-1 plays a key role in promoting muscle regeneration and re-establishment of muscle function. We believe VMB-100 has the potential to fill the current therapeutic gap as a first-in-class mRNA therapy that can restore muscle function and thereby effectively treat incontinence.” 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to a report on GlobalData’s Pharma Intelligence Centre, the global market sales in the overactive bladder market are forecast to reach $2.8bn in 2030. 

GlobalData is the parent company of Clinical Trials Arena.