Leading in the development of functional treatments for type 1 diabetes, apex drugs We shared exciting advances From that phase 1/2 clinical trial, American Diabetes Association’s 84th Annual Science Session.
Quick highlights of current 12 participants for the VX-880 trial:
- Participants received a single injection of VX-880. This is a transplant of healthy laboratory-grown islet cells containing insulin-producing beta cells that die from type 1 diabetes.
- All participants are currently producing “endogenous” insulin. Their bodies are again producing insulin.
- Seven participants achieved insulin independence by the 180-day mark after receiving a VX-880 infusion. This means that you no longer need daily insulin therapy via injections or pumps.
- The two may reduce their insulin needs by 70% and achieve “insulin independence” in the future.
- One participant needs 24% less insulin per day.
- Of the 12 participants, 11 have significantly reduced or completely eliminated the need for daily insulin therapy.
Here we will be looking at this VX-880 and The mission of the vertex Developing treatments for type 1 diabetes.
What is the VX-880?
VX-880 is the first apex therapeutic therapy using insulin-producing islet cells injected directly into the liver portal vein of participants. This vein transports blood from the pancreas to the liver.
For decades, we have known that it is possible to implant healthy insulin-producing cells into the body of a person with type 1 diabetes. Unfortunately, islet cell transplantation is not a practical solution for the majority of people with this condition. One of the main reasons is the fact that is the fact that is only possible to collect islet cells from the pancreas of a broken organ donor.
The apex broke new ground by improving the technology to mass-produce new islet cells in the laboratory using pluripotent stem cells. It appears that islet cell transplantation is no longer limited by the number of organ donors available. In fact, last year we partnered with Lonza. Construction of a manufacturing factory New Hampshire is completely dedicated to the production of these insulin-producing cells. (That should tell you how serious the company is about bringing this to the market someday!)
The results strongly suggest that its peak‘Cells grown in the S lab work. The majority of study participants are currently insulin-independent.
If there is a catch, it is the fact that the VX-880 requires immunosuppressive therapy. Otherwise, the immune system will attack and destroy these new foreign cells. As exciting as the potential insulin independence, many people in the Type 1 diabetes community are naturally nervous about switching from one drug regimen to another.
The participation requirements for the VX-880 were relatively limited for this reason. The side effects and risks associated with immunosuppressive therapy must be valuable. Among other complications, all participants in the VX-880 clinical were experiencing frequent and severe hypoglycemic events prior to the study.
According to this recent update, 12 exam participants have never experienced it Any Severe hypoglycemic event. There were no significant side effects or complications from the VX-880.
You should also know about the VX-264
Is VX-880 a treatment if it gives insulin independence? That’s an unresolved question. Some experts believe that type 1 diabetes can only be cured if it does not require immunosuppressive treatment.
The VX-880 trial is the first step to test the efficacy of these manufactured cells, but there are also plans to test versions of treatments that do not require anti-rejection drugs at the apex.
VX-264 is the second apex clinical trial focusing on functional treatment of T1D. VX-264 uses the same manufactured insulin-producing cells, but does not have immunosuppressive therapy. Instead, VX-264 uses a device surgically implanted with cells to protect cells from the immune system. It physically blocks immune cells while allowing insulin to flow into the blood.
The VX-264 has begun adoption It’s mid-2023, but the vertex has not yet shared any significant results.
The success of VX-880 paves the way for VX-264, as it means that the cells themselves will produce insulin successfully. The tricky part is developing effective ways to protect them from the recipient’s immune system.
Deaths of two participants
Originally, there were 14 participants in the VX-880 exam. Two participants died In the second half of 2023, the vertices had to officially suspend. The vertices shared details of these deaths in this latest update.
The deaths of both participants were deemed unrelated to the trial.
- Participant deaths 1: “Crypto-tumor inflammatory infections due to the use of high-dose steroids in the weeks before and after sinus surgery (prohibited by protocol), selective sinus surgery for immunosuppressive therapy (rib plate damage), and high-dose steroids (prohibited by protocol),”
- Amateur Terminology: Fungal infection and the use of high-dose steroids after spontaneous facial surgery can cause severe hyperglycemia.
- Participant’s Death No. 2: “Progression of existing neurocognitive impairment due to severe traumatic brain injury sustained in a car accident caused by a severe hypoglycemia event before the study registration.”
- Amateur Terminology: Progression of brain damage caused by a car accident that occurred before the test. The accident was caused by a serious hypoglycemia event.
With the utmost respect for these participants and their family and friends, Daily Diabetes thanked these two for their contributions to this groundbreaking treatment research.
The top is still recruiting more people with type 1 diabetes
Thanks to its success so far, Vertex has received US Food and Drug Administration clearance, expanding its trials and enrolling 37 participants.
(TagstoTranslate)Beta Cell (T)Therapeutic Research (T)Insulin (T)Intensive Management (T)Island Cell Transplantation (T)US Food and Drug Administration (FDA) (T)Apex (T)VX-264