Diamyd Medical and JDRF recently announced a four-year research and development collaboration focused largely on the Phase 3 trial of Diamyd’s immunotherapy treatment for people recently diagnosed with type 1 diabetes (T1D).

“We could not have a better partner than JDRF as we are focusing on rapid advancement of our antigen-specific immunotherapy towards the market,” said Ulf Hannelius, CEO of Diamyd Medical, in a recent press release. “We expect this collaboration to significantly boost patient recruitment to this international study as well as our commercial preparations.”

Here’s a closer look at this groundbreaking research.

How Diamyd immunotherapy works in recently diagnosed T1D

The “DIAGNODE-3 Diabetes Study” involves administering Diamyd — an antigen-specific immunotherapy — directly into the lymph nodes of adolescents and adults who’ve been recently diagnosed with T1D and carry a specific gene: the HLA DR3-DQ2 haplotype.

The intention of this immunotherapy is to preserve and protect the recipient’s natural insulin production, and essentially stop the autoimmune attack on those vital insulin-producing beta cells.

This means there is no introduction of exogenous (from outside of the body) cells that require immunosuppressive therapy. Instead, Diamyd works to protect your body’s endogenous (from within the body) insulin production.

This endogenous factor is what differentiates Diamyd from other T1D treatment approaches which involves the introduction of exogenous insulin-producing cells that must be protected from the immune system.

Additionally, Diamyd is only being tested at this time in those who’ve been recently diagnosed versus those who’ve lived with T1D for years or decades.

How to measure the results of Diamyd immunotherapy

Participants in the DIAGNODE-3 trial will be monitored for the following in order to determine the impact of Diamyd on their natural insulin production: 

  • Changes in C-peptide level: C-peptide levels indicate how much insulin your body is producing.
  • Changes in HbA1c level: Also known as A1c, this measures the amount of “advanced glycogenated end-products” (AGEs) are essentially excess sugar that has attached to cells throughout your body during the prior three months. The higher your blood sugar levels are, the more AGEs accumulate in your body, the higher your A1c will be.
  • Changes in time-in-range: Also known as TIR, this measures how much of your hour-by-hour blood sugar levels are within a specific target range. In this study, the target range is 70 to 180 mg/dL (3.9 to 10 mmol/L).
  • Number of patients still taking daily insulin via injection/pump: The goal, of course, is to reduce the number of participants who need daily insulin therapy in order to achieve target blood sugar levels!
  • Number of severe hypoglycemia or diabetic ketoacidosis events: Severe hypoglycemia qualifies as requiring assistance from others to treat. Diabetic ketoacidosis is the presence of moderate ketones due to a severe lack of insulin.

While recruitment within the United States is expected to begin in Summer 2023, this trial is already ongoing in many other countries, including Czech Republic, Estonia, Germany, Berlin, Hungary, Netherlands, Poland, and Spain.

Other Diamyd research for those with T1D for 5+ years

Diamyd Medical has also been working on a treatment for those who’ve lived with T1D for over five years — called Remygen. Remygen is a proprietary formula that signals to the insulin-producing cells in the pancreas. So far, it’s been shown to stimulate the growth and function of insulin and glucagon-producing cells.

Still in the early stages of research, Remygen aims to restore the natural hormonal protection against hypoglycemia and beta cell function in people with T1D.

JDRF backs DIAGNODE-3 research with $5 million award

JDRF has awarded Diamyd Medical with $5 million to continue this groundbreaking research. Their support isn’t surprising considering their ongoing efforts to help detect T1D in the earliest stages, — potentially years before symptoms develop — through the T1Detect screening program.

“JDRF is committed to supporting and advancing disease modifying therapies to delay and reverse type 1 diabetes,” said Sanjoy Dutta, Ph.D., Chief Scientific Officer at JDRF in the press release. “We are excited about Diamyd Medical’s groundbreaking Phase 3 trial and its potential advancements in the preservation of insulin production for people recently diagnosed with type 1 diabetes.”

“JDRF has played a crucial role in many of the most novel therapeutics and devices that have been approved in the field for those with type 1 diabetes,” said Mark Atkinson, Ph.D., director of the Diabetes Institute at the University of Florida and Diamyd Medical Board Member. “JDRF’s commitment to this Phase 3 program is a validation of the scientific and clinical value of the antigen-specific immunotherapy Diamyd. It also emphasizes the importance of making disease modifying therapies available to everyone affected by this disease.”