“ReGenerate-1 includes patients who have had type 1 diabetes for many years,” says Per-Ola Carlsson, Professor at Uppsala University and Uppsala University Hospital, Sponsor of the trial. “The interest in participating has been great, and this is probably due to the fact that the trial is aimed at type 1 diabetes patients who generally cannot participate in clinical trials due to the disease being too advanced. This trial provides a unique opportunity to evaluate the body's ability to regenerate its own insulin production with the help of Remygen and to investigate whether Remygen can prevent episodes of  too low blood sugar.”

“This is an important trial for the development of Remygen and our GABA-based platform in diabetes,” says Ulf Hannelius, CEO of Diamyd Medical. “The results from the dose escalation section of the trial, published in October last year, were very interesting and we look forward to the results from the main trial. With Remygen we cover a different group of patients than with Diamyd, which is of course also interesting from a market perspective.”

About ReGenerate-1
ReGenerate-1 is an open-label, investigator initiated clinical trial involving a total of 35 patients aged 18-50 who have had type 1 diabetes for longer than five years with low to non-existing residual insulin production. The trial is conducted at Uppsala University Hospital with Professor Per-Ola Carlsson as Principal Investigator. The trial consists of two parts; an initial safety and dose escalation part comprising six patients, and the main trial, which comprises 35 patients who will be followed up to nine months depending on the dose group to which they belong. The main purpose is to evaluate the safety of Remygen^® and the combination of Remygen^® and the GABA receptor-modulating substance Alprazolam. The trial will also examine whether Remygen^® alone and in combination with Alprazolam can have a positive effect on the hormonal counter-regulatory response to low blood sugar and on the restoration of beta cell function, potentially allowing in the long run a patient to regain insulin producing capacity.

The results from the dose-escalation part of ReGenerate-1 are published in the article “GABA induces a hormonal counter-regulatory response in subjects with long-standing type 1 diabetes” that can be accessed at https://drc.bmj.com/content/9/1/e002442.

About Remygen^®
Remygen^® is Diamyd Medical’s proprietary formualtion of GABA, a key cell signalling molecule in the islets of Langerhans found in the pancreas. GABA has been shown to affect the secretion of insulin and glucagon both in healthy volunteers and in patients. Preclinical studies have shown strong indications that GABA stimulates the growth and function of the insulin and glucagon producing cells in the pancreas. Preclinical studies have also shown that GABA receptor modulating agents such as Alprazolam may increase the positive effect of GABA on the insulin producing cells.

About Diamyd Medical
Diamyd Medical develops precision medicine therapies for type 1 diabetes. The diabetes vaccine Diamyd^® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. Preparations for a confirmatory Phase III trial are on-going. A vaccine manufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd^®. Diamyd Medical also develops the GABA-based investigational drug Remygen^® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen^® trial in individuals living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB as well as in the artificial intelligence company MainlyAI AB.

Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se

For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com

Diamyd Medical AB (publ)
Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com

The information was provided by the contact person above, for publication on  February 8, 2022, 14.00 CET.