Diamyd Medical pauses start of Phase III trial – Update

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The potential contamination is not connected to the new manufacturing facility being established in Umeå.

Diamyd Medical has today decided to pause the start of the precision medicine Phase III trial DIAGNODE-3 as well as the initiation of other clinical trials with the diabetes vaccine Diamyd® (GAD/alum) pending additional evaluations of the manufacturing process. A new analysis has shown the potential presence of a contamination early in the manufacturing process of the drug substance (GAD65) used in the existing study drug. Diamyd Medical will evalaute its specific removal before additional clinical work is conducted. The potential contamination is not connected to the new manufacturing facility being established in Umeå.

“We take this new information seriously and deem it is most prudent to pause the initiation of pending clinical trials in order to thoroughly assess the situation”, says Ulf Hannelius, CEO of Diamyd Medical. “While our insights regarding precision medicine, safety and efficacy have elevated the diabetes vaccine, recent events show that we have challenges with manufacturing”. “For the time being we will focus all our resources on strengthening the manufacturing platform to make sure the diabetes vaccine Diamyd® can reach its full potential”.

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
info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com

This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was provided by the contact person above, for publication on November 30, 2021, 22.15 CET.



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