Diamyd Medical AB ser. B
Diamyd Medical AB: Results from the EDCR IIa trial where Diamyd is given subcutaneously
30-month results from EDCR IIa, an investigator initiated pilot trial
in which the diabetes vaccine Diamyd is given subcutaneously
combined with etanercept and vitamin D, show that the treatment is
safe and tolerable. No serious side effects have been reported. As
expected, based on previously reported 15-month results, the results
at 30 months show no clear positive effect on the clinical course of
When all 20 patients had been followed for 30 months in the EDCR IIa
trial, endogeonus insulin production (measured as stimulated
C-peptide) had decreased on average by 70% and fasting C-peptide had
decreased by 63%. Furthermore, the long-term blood glucose level
HbA1c had on average increased by 17% and external insulin
requirements increased by 111%. The treatment has been safe and
tolerable and no serious side effects have been reported.
The results from the trial further strenghten our view that the
method of administration of Diamyd is crucial for achieving a
clinically relevant effect, says Ulf Hannelius, CEO of Diamyd
Medical. When Diamyd is given under the skin, as in EDCR IIa, the
same promising treatment effect is not achieved as when the diabetes
vaccine is given intralymphatically as in the DIAGNODE-1 trial, where
we have seen very promising clinical and immunological results.
The combination with etanercept and Diamyd subcutaneously did not
show any convincing effect on a group level, says Johnny Ludvigsson,
Professor at Linköping University and Sponsor for EDCR IIa.
Immunological analyzes from the trial will, however, be important in
examining the treatment effect at the individual level.
About EDCR IIa
The Phase II trial EDCR IIa (Etanercept-Diamyd-Combination-Regimen)
has been conducted at eight pediatric diabetes clinics in Sweden. The
trial was an open label clinical pilot trial in children and
adolescents between 8 and 18 years of age, newly diagnosed with type
1 diabetes, in which subcutaneous administration (under the skin) of
the diabetes vaccine Diamyd was combined with two already approved
substances, the immunosuppressive drug etanercept and vitamin D. The
patients have now been followed for the whole study period, a total
of 30 months. The aim of the study has been to to evaluate the safety
of the combination treatment as well as its impact on the immune
system and the patients insulin producing capacity.
About Diamyd Medical
Diamyd Medical develops the diabetes vaccine Diamyd, as an
antigen-specific immunotherapy for the preservation of endogenous
insulin production. Diamyd has demonstrated good safety in trials
encompassing more than 1,000 patients as well as effect in some
pre-specified subgroups. Besides the Companys own European Phase-IIb
trial DIAGNODE-2 where the diabetes vaccine is administered directly
into a lymph node, three investigator initiated clinical trials are
ongoing with Diamyd. Diamyd Medical also develops the GABA-based
investigational drug Remygen for regeneration of endogenous insulin
production. An investigator-initiated Remygen trial in patients
living with type 1 diabetes for more than five years is ongoing at
Uppsala University Hospital. An investigator-initiated trial with
GABA and Diamyd in patients recently diagnosed with type 1 diabetes
is also ongoing at the University of Alabama at Birmingham, USA.
Diamyd Medical is one of the major shareholders in the stem cell
company NextCell Pharma AB and has holdings in the medtech company
Companion Medical, Inc., San Diego, USA.
Diamyd Medicals B-share is traded on Nasdaq First North under the
ticker DMYD B. FNCA Sweden AB is the Companys Certified Adviser;
phone: +46 8-528 00 399, e-mail: email@example.com.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26,
Fax: +46 8 661 63 68
E-mail: firstname.lastname@example.org Reg. no.: 556242-3797 Website:
The information was submitted for publication, through the agency of
the contact person set out above, at 08.17 CET on April 16, 2019.