New clinical trial will evaluate an additional injection (booster) with Diamyd®
A new investigator-initiated clinical trial, DIAGNODE-B, will start this spring. The trial will evaluate the safety, impact on the immune system and the clinical efficacy of an additional injection with the antigen-specific immunotherapy Diamyd®. The trial has been approved by the Swedish Medical Products Agency and the Ethical Review Authority and will be offered to approximately 6 patients from the previous trials DIAGNODE-1 and DIAGNODE-2.
The patients who will be included in DIAGNODE-B have previously been treated with either three or four intralymphatic injections of Diamyd®. All patients carry the genetically defined HLA DR3-DQ2 haplotype, which has shown to be linked to significant and clinically relevant treatment efficacy with Diamyd®.
DIAGNODE-B is based on an earlier analysis from the DIAGNODE-trial, announced on December 20, 2019, where three patients received an additional Diamyd® injection into the lymph node after their 30-month visit. The analysis showed a preserved insulin production between the 30 - and 43-month visits. A follow-up analysis, communicated on August 26, 2021, showed that all three individuals who received an additional injection were positive for HLA-DR3-DQ2.
About DIAGNODE-B
DIAGNODE-B is an open-label investigator-initiated clinical trial planned to enroll Type 1 Diabetes patients who carry the genetically defined haplotype HLA DR3-DQ2 and are previously treated with intralymphatic injections of Diamyd® at Crown Princess Victoria Children's Hospital in Linköping. The trial is planned to include approximately 6 patiens who have either been treated with four injections in DIAGNODE-1, who will then receive a 5th intralymphatic injection of Diamyd®, or patients who participated in DIAGNODE-2, who will receive a 4th intralymphatic injection of Diamyd®, approxinmately 4 years after the last injection. The aim of the trial is to evaluate the safety of a booster (fourth/fifth) injection with Diamyd® and the effect on the immun system and the endogenous insulin production. The patients will be followed for 12 months after injection.The trial will be conducted at the Clincal Resarch Unit at the University Hospital in Linköping. Sponsor of the trial is Linköping University with Professor Johnny Ludvigsson as Sponsor’s representative. Diamyd Medical contributes with study drug, expertise and some financial support.
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. DIAGNODE-3, a confirmatory Phase III trial is 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 April 13, 2022, 14.25 CET.