Recent Insider Transactions • Jul 29
Chief Executive Officer recently bought kr98k worth of stock On the 27th of July, Anders Essen-Möller bought around 100k shares on-market at roughly kr0.98 per share. This transaction amounted to 2.9% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth kr100k. Anders has been a buyer over the last 12 months, purchasing a net total of kr408k worth in shares. Announcement • Jul 27
Diamyd Medical AB (publ) Provides Update On Learnings From DIAGNODE-3 Interim Analysis Diamyd Medical AB (publ) provided an update on learnings from its internal and external review of the pre-specified interim efficacy analysis from the pivotal Phase 3 DIAGNODE-3 trial. The trial evaluated the investigational antigen-specific immunotherapy retogatein (rhGAD65) in individuals with recent-onset Stage 3 type 1 diabetes carrying the HLA DR3-DQ2 haplotype. The pre-specified interim analysis included 174 of 321 enrolled participants at 15 months after the first study injection. The primary efficacy analysis did not achieve statistical significance, and the pre-specified continuation criteria were not met. The Company is closing DIAGNODE-3 for futility in accordance with the trial's pre-specified decision framework. No new safety concerns were identified in connection with the interim analysis or subsequent review. Since receiving the interim results, Diamyd Medical has conducted a structured review of trial conduct, drug product characteristics, administration procedures, and available clinical data. The review did not identify any single reason, cause or design flaw that explains the outcome. No material protocol violations were identified. Instead, the review identified several factors that may warrant consideration in the design of any future preventive or therapeutic clinical study. These observations are hypothesis-generating and should not be interpreted as established explanations for the outcome of DIAGNODE-3. Treatment administration: Intralymphatic administration may be operationally demanding in a large, multicenter trial in which individual sites treat relatively few participants. Compiled evidence from clinical trials to date potentially favors the more robust subcutaneous administration method. Future protocols could consider enhanced training, documentation, and quality-control measures in case of intralymphatic administration of study drug. Timing of treatment: Exploratory analyses, and experience from other studies for the treatment of recent onset Stage-3 Type-1 Diabetes, suggest that a shorter interval between diagnosis and first treatment may be of merit. The available subgroups in DIAGNODE-3 were small and did not support definitive conclusions. Drug product potency: The measured potency of the drug product used in DIAGNODE-3 appears to have been lower than that used in the preceding DIAGNODE-2 study. There was a clear immunological response resulting from exposure in DIAGNODE-3, and the clinical relevance of the difference in potency has not been established, but is a factor that should be considered in future trials. Exploratory subgroup findings: Numerical trends were observed in certain subgroups; however, these analyses were not powered for confirmatory inference and involved limited participant numbers. They should therefore be viewed as exploratory only. Taken together, the review supports several potential lessons for future study design of antigen-specific tolerization studies with GAD65 as the active product ingredient in individuals with recent onset Stage-3 Type-1 Diabetes, including strengthened controls around intralymphatic administration, evaluation of earlier treatment after diagnosis, and further refinement of drug-product potency assessment. Any future clinical development would require an appropriately designed prospective study and engagement with relevant regulatory authorities. Diamyd Medical's GMP-certified biologics facility in Umeå continues its program and capabilities for the manufacture of recombinant GAD65 for investigational use. The Company is in parallel evaluating strategic opportunities related to its development assets, manufacturing platform, and potential partnerships. A decision to initiate a new clinical efficacy trial with retogatein for the prevention or treatment of AutoImmune Diabetes would be subject to scientific, regulatory, strategic, and financial assessment. Recent Insider Transactions • Jul 01
Chief Executive Officer recently bought kr100k worth of stock On the 24th of June, Anders Essen-Möller bought around 100k shares on-market at roughly kr1.00 per share. This transaction amounted to 3.0% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth kr210k. Anders has been a buyer over the last 12 months, purchasing a net total of kr310k worth in shares. 
