Vertero completes participant enrolment in the Netherlands for a clinical trial of its new gut targeted treatment VT 5006

The biotechnology company Vertero Therapeutics announced that it had finished recruiting the 24 participants needed for the final stage of its Phase 1 clinical study testing an experimental oral capsule called VT 5006, also known as AX 5006. Taking place at the Centre for Human Drug Research in Leiden in the Netherlands, the trial is investigating a fresh approach that bypasses the traditional challenge of getting medicines directly into the brain by focusing instead on the digestive tract. Most existing medications do a vital job of managing day to day symptoms by topping up chemical messengers in the brain, yet they do not stop the condition from progressing. For years, researchers have observed that digestive issues, particularly persistent constipation and slow gut movement, often appear years before any physical movement changes begin. Scientists now believe that for many people, the biological spark that sets off the condition actually starts inside the gut. Our digestive tract is home to trillions of microbes. Some of the bacteria living in the gut produce a sticky protein called CsgA. Research has shown that this bacterial protein can act like a bad influence on a normal human protein called alpha synuclein, encouraging it to fold the wrong way and clump together inside the nerves lining the gut. At the same time, it stirs up local inflammation. Over time, these protein clumps and inflammatory signals can travel up the nerve pathways that connect the digestive system to the brain. VT 5006 is a small molecule medicine taken as a capsule by mouth. Unlike standard drugs that dissolve into the bloodstream to travel around the entire body, VT 5006 is designed to stay primarily inside the digestive tract. Its sole job is to find and block that bacterial CsgA protein right where it lives. By disarming this trigger in the gut, researchers hope to quieten the knock on effect of protein clumping and inflammation, potentially slowing down the progression of the condition while easing digestive symptoms. The trial in the Netherlands began in late October 2025 and was designed in three carefully stepped parts involving around 84 people in total. The first two parts, known as Phase 1a, enrolled healthy volunteers aged between 18 and 54 to check the basic safety of the capsules. In the first group, volunteers took a single dose after fasting overnight and stayed in the clinic for three nights of monitoring, with one small group returning two weeks later to take the capsule after a high fat meal to see if food changed how the medicine behaved. In the second group, healthy volunteers took the capsule every day for a full week during a ten night clinic stay. Both of these early stages wrapped up earlier this year with clean safety results and no concerning side effects, giving the green light to invite people living with the condition to take part. This third and final part of the trial, known as Phase 1b, has just completed enrolment of 24 adults aged between 40 and 80 who were diagnosed within the last ten years and are in the early or moderate stages of the condition. Because the medicine targets a gut trigger, everyone taking part in this group had to test positive for the bacterial CsgA protein and have a history of slow gut movement or ongoing constipation. Participants also needed to be on a stable routine with their regular medications, including keeping their standard levodopa doses steady for at least three weeks beforehand, and be comfortable swallowing large capsules. Over a 28 day period, nine participants are taking a low daily dose of VT 5006, nine are taking a high daily dose, and six are taking a matching dummy capsule known as a placebo. It is a double blind trial, meaning neither the volunteers nor the doctors know who is receiving the active medicine until the study finishes. Taking part involves a real commitment, including two overnight stays at the Leiden clinic, three daytime clinic visits, a telephone check in, and a final follow up appointment. Alongside standard heart traces and blood tests to check safety, researchers are measuring how much of the medicine stays in the digestive tract through stool samples and how little passes into the blood and urine, as well as checking spinal fluid to see the wider biological effects. Vertero Therapeutics expects to share the main results from this 28 day study before the end of 2026. Because this is a Phase 1 trial, the primary goal is not yet to prove that the medicine slows down the condition, but rather to confirm that it is safe for people with Parkinson's to take every day and that it successfully locks onto its bacterial target in the gut. If the end of year results look promising, the company will use this data to pick the ideal dose for a larger Phase 2 trial to properly test how well VT 5006 works over a longer timeframe.