First, disclaimer, I'm a patient (MOGAD), not a medical professional.
As far as phases goes, as far as I understand it, phase 1 is safety, phase 2 is initial trial for efficacy.
Quote from the website about Type 1 diabetes:
> In Type 1 diabetes (T1D), the insulin-producing beta cells in the pancreas are destroyed through an autoimmune attack. The loss of beta cells leads to insulin insufficiency and hyperglycemia, with patients eventually requiring lifelong insulin therapy to maintain normal glycemic control.
...
>IMCY-0098, a synthetic peptide based on insulin (one of the proteins to which the body begins to mount an aberrant immune response) is designed to halt the progression of diabetes by stopping the body’s immune system from attacking beta cells. With early intervention, the pancreas’ ability to produce insulin may be preserved, enabling patients to manage the disease with minimal insulin injections and hopefully in some cases without the need for insulin at all.
> In a Phase 1b study with 41 newly diagnosed patients, IMCY-0098, was found to be safe and well tolerated, with steady levels of C-peptides detected in some T1D patients up to 6 months following treatment, providing an encouraging signal for the Imotope™ platform.
> IMCY-0098 is currently being investigated in a Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose comparison study in patients with recent onset T1D. .... The study completed recruitment in March 2023 exceeding its recruitment target, with a total of 110 patients enrolled and randomized across 28 clinical sites in Europe, the United States and Australia. Efficacy proof-of-concept data from IMPACT is expected in Q1 2024.
I've been following this company: http://imcyse.com/pipeline#type-1-diabetes
First, disclaimer, I'm a patient (MOGAD), not a medical professional. As far as phases goes, as far as I understand it, phase 1 is safety, phase 2 is initial trial for efficacy.
Quote from the website about Type 1 diabetes:
> In Type 1 diabetes (T1D), the insulin-producing beta cells in the pancreas are destroyed through an autoimmune attack. The loss of beta cells leads to insulin insufficiency and hyperglycemia, with patients eventually requiring lifelong insulin therapy to maintain normal glycemic control.
...
>IMCY-0098, a synthetic peptide based on insulin (one of the proteins to which the body begins to mount an aberrant immune response) is designed to halt the progression of diabetes by stopping the body’s immune system from attacking beta cells. With early intervention, the pancreas’ ability to produce insulin may be preserved, enabling patients to manage the disease with minimal insulin injections and hopefully in some cases without the need for insulin at all.
> In a Phase 1b study with 41 newly diagnosed patients, IMCY-0098, was found to be safe and well tolerated, with steady levels of C-peptides detected in some T1D patients up to 6 months following treatment, providing an encouraging signal for the Imotope™ platform.
> IMCY-0098 is currently being investigated in a Phase 2 multicenter, randomized, double-blind, placebo-controlled, dose comparison study in patients with recent onset T1D. .... The study completed recruitment in March 2023 exceeding its recruitment target, with a total of 110 patients enrolled and randomized across 28 clinical sites in Europe, the United States and Australia. Efficacy proof-of-concept data from IMPACT is expected in Q1 2024.