Recently, IM Therapeutics, a developer of therapies for patients with autoimmune conditions, announced the start of a Phase 1b clinical trial designed to evaluate IMT-002 for type 1 diabetes. Interestingly, this is the first ever drug of its kind to be analyzed for this patient population. During the Phase 1b trial, IM Therapeutics will evaluate the safety and tolerability of IMT-002, as well as the efficacy of multiple ascending doses.
IMT-002
Developed by IM Therapeutics, IMT-002 is a selective HLA-DQ8 blocker. An estimated 60% of all patients with type 1 diabetes have genetic trait called HLA-DQ8, caused by HLA gene mutations. As a result, the immune system is mistakenly activated. However, no prior treatments attempted to treat this genetic variant.
In the Phase 1a trial, IMT-002 was shown to be relatively safe for patients. Now, in the Phase 1b trial, enrolled patients will receive different IMT-002 doses. 30 patients (18-45) will enroll in the trial. 24 patients will receive IMT-002 and 6 patients will receive a placebo. In addition to safety and tolerability, the Phase 1b trial will also analyze the drug’s pharmacokinetics.
Type 1 Diabetes
According to the Mayo Clinic, type 1 diabetes (T1D):
once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy.
While IM Therapeutics considers T1D to be an autoimmune disorder, others consider genetics or viral infections as factors in developing the condition. While T1D can occur in adolescence, it typically occurs in adults. Currently, there are no cures for T1D.
Symptoms include:
- Increased thirst and frequent urination
- Bed-wetting (in children)
- Intense fatigue
- Blurred vision
- Long-lasting cuts and bruises
- Irritability
- Unintended weight loss
- Tingling or numbness in the hands and feet
- Extreme hunger
The American Diabetes Association notes that unlike in type 2 diabetes, patients with T1D often have a very fast symptom onset. Without treatment, complications may occur. These include skin infections, glaucoma, and diabetic neuropathy.
Learn more about type 1 diabetes.
