STOCKHOLM, July 30, 2024 /PRNewswire/ -- Diamyd Medical
today announced a successful interim analysis (non-futility test)
for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The
interim analysis, reviewed by an independent Data Safety Monitoring
Board (DSMB), resulted in a favorable recommendation to continue
the trial without any modifications.
"We are extremely pleased with the DSMB's recommendation to
continue the DIAGNODE-3 trial as planned," says Ulf Hannelius, CEO of Diamyd Medical. "This
positive outcome reaffirms our confidence in the potential for
Diamyd® to address an unmet medical need in Type 1
Diabetes. We are committed to advancing this promising therapy as
part of a process recently approved by the U.S. Food and Drug
Administration, allowing for an accelerated approval pathway for
Diamyd®. We look forward to achieving our
next milestones towards this goal."
The interim analysis evaluated six-month data from 74 patients
enrolled in the trial, assessing the likelihood of the trial
achieving one of its co-primary endpoints, specifically the
preservation of endogenous insulin-producing capacity measured as
stimulated C-peptide. The DSMB's recommendation is based on the
data observed to date, indicating that the trial is on track and
has the potential to meet its objectives.
About DIAGNODE-3
The confirmatory Phase III trial DIAGNODE-3 (www.diagnode-3.com),
evaluating the safety and efficacy of the antigen-specific
immunotherapy Diamyd® in individuals diagnosed with
Type 1 Diabetes is ongoing in the United
States and in eight European countries: Sweden, Spain, the Czech
Republic, the Netherlands,
Germany, Poland, Hungary and Estonia.
DIAGNODE-3 will enroll up to 330 individuals aged 12 to 29
years, recently diagnosed (within six months) with Type 1 Diabetes,
who carry the HLA DR3-DQ2 haplotype, a certain genetic risk factor
for this disease. A further stratification for HLA haplotypes is
included to evaluate a potential superresponder group of
individuals who are positive for HLA DR3-DQ2 and negative for HLA
DR4-DQ8. HLA testing is well-established and widely available to
identify such individuals, through a precision based medicine
approach.
This patient population is based on clinical efficacy and safety
results from the Phase IIa and Phase IIb trials DIAGNODE-1 and
DIAGNODE-2, as well as on the large-scale meta-analysis
encompassing data from more than 600 individuals from previous
Phase II and Phase III trials using Diamyd®. The trial
design provides a high probability of reaching its co-primary
endpoints of preservation of endogenous insulin-producing capacity
measured as stimulated C-peptide and improved blood glucose control
as determined by HbA1c.
As previously announced, Diamyd Medical is evaluating the
potential of an earlier readout in the DIAGNODE-3 trial. This is
based on the FDA acknowledging that C-peptide could be used by
Diamyd Medical as a surrogate endpoint that is reasonably likely to
predict the clinical benefit of preservation of endogenous insulin
production. As such, Accelerated Approval could be sought based on
demonstrating significant treatment-related benefits on C-peptide
levels in response to Diamyd® administration.
DIAGNODE-3 is supported, in part, by funding from Breakthrough
T1D (formerly JDRF), the leading global Type 1 Diabetes research
and advocacy organization.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies for the
prevention and treatment of Type 1 Diabetes and LADA (Latent
Autoimmune Diabetes in Adults). Diamyd® is an
antigen-specific immunomodulatory therapeutic for the preservation
of endogenous insulin production that has been granted Orphan Drug
Designation in the U.S. as well as Fast Track Designation by the
U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes.
DIAGNODE-3, a confirmatory Phase III trial is actively recruiting
patients with recent-onset (Stage 3) Type 1 Diabetes in eight
European countries and in the US. Significant results have
previously been shown in a large genetically predefined patient
group - in a large-scale meta-analysis as well as in the Company's
prospective European Phase IIb trial, where Diamyd® was
administered directly into a superficial lymph node in children and
young adults with recently diagnosed Type 1 Diabetes. Injections
into a superficial lymphnode can be performed in minutes and are
intended to optimize the treatment response. A biomanufacturing
facility is under development in Umeå, Sweden, for the manufacture of recombinant
GAD65 protein, the active ingredient in the antigen-specific
immunotherapy Diamyd®. Diamyd Medical also develops the
GABA-based investigational drug Remygen® as a component
in the treatments of metabolic diseases. Diamyd Medical is a major
shareholder in the stem cell company NextCell Pharma AB and 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.
CONTACT:
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
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