Preliminary 15-month results from DIABGAD – a 30-month pilot study with the diabetes vaccine Diamyd® in combination with vitamin D and ibuprofen

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced
from a clinical investigator-initiated pilot study, DIABGAD-1, that the diabetes
vaccine Diamyd® in combination with vitamin D and ibuprofen after 15 months has
a good safety profile with no reported serious side effects related to the
treatment. The data shows that after the initial phase (referred to partial
remission or the honeymoon phase), the group receiving placebo (non-active
substance) lost their ability to produce insulin at a rate that was 2-3 times
faster during the last 9 months of the 15-month period, compared with the groups
receiving active treatment with Diamyd®. However, viewed over the entire 15
-month period no difference between the groups is observed, but if the more
rapid decrease continues in the placebo group until the end of the study at 30
months, a trend deviation in insulin production may be observable throughout the
full measurement period, that is, including the remission period.
The DIABGAD-1 study, which is the first of its kind, combines the diabetes
vaccine Diamyd® with vitamin D and the anti-inflammatory drug ibuprofen, and is
conducted at nine pediatric diabetes clinics in Sweden, with Professor Johnny
Ludvigsson, Linköping University, as the principal investigator and sponsor.

The purpose of the pilot study is to test the combination therapies’ safety and
how they impact the body’s own ability to produce insulin in children and
adolescents newly diagnosed with type 1 diabetes. The participants will be
monitored for 30 months.

“It is clearly interesting that the fall-off in the ability to produce insulin
is slower among patients receiving active treatment during the 6-15 month period
of the study, that is, following the usually relatively stable initial half year
after diagnosis,” says Professor Johnny Ludvigsson at Linköping University, who
is the principal investigator and sponsor of the study. “If this trend persists,
our combination therapy may show results in another 15 months that are
clinically significant.”

The preliminary 15-month results indicate that the safety of the combination
therapy is good and no serious adverse events related to the treatment have been
reported.

Following the start of insulin treatment, many type 1 diabetes patients enter
partial remission which, depending on age, can extend over a period of a few
months up to a couple of years (Pecheur et al., J Diabetes Research,
2014:851378). For this reason, the effects of the various combination therapies
is presented below as the difference in the insulin-producing capacity between
the date for the 6-month visit after inclusion in the study, which is close to
the mean value for the length of the stable phase (partial remission), and the
visit 15 months after inclusion in the study. Over the course of these 9 months,
the ability to produce insulin (measured as C-peptide Area Under the Curve (AUC)
in nmol/L) decreases in the placebo group at a rate that is 2-3 times faster
than the groups treated with Diamyd®. If this more rapid decrease continues
among the placebo group until the end of the study at 30 months, a trend
deviation in insulin production may be observable throughout the complete
measurement period, that is, including the remission period.

“You have to keep in mind that this is a small study and we have only obtained
descriptive data from the 15-month results, meaning no formal analysis has been
performed. Furthermore, the remission period could be playing tricks on us. All
of this means that it is far too early to celebrate,” says Anders Essen-Möller,
President and CEO of Diamyd Medical. “But we are certainly cautiously excited
about the results that Johnny’s team has observed from month 6 and onward, and
we are carefully monitoring developments from month 15 to 30 given that this is
an important part of the puzzle in the work pursued by Diamyd through its many
studies.”

From the date of inclusion up to 15 months, meaning including the estimated
remission period, no difference in insulin production, measured as C-peptide
AUC, is observable between the groups. However, measured from month 6 to month
15, the capacity to produce insulin declined in the placebo group (n=10) by 0.28
nmol/L (41%), while the group that received Diamyd®, vitamin D and ibuprofen
(n=11) declined by 0.10 nmol/L (20%); the group receiving Diamyd® and vitamin D
(n=15) declined by 0.08 nmol/L (16%), and the group that received a double dose
of Diamyd® and vitamin D (n=14) declined by 0.09 nmol/L (17%).

[image]

[image]

In a previous Phase III study (n=334), treatment with the diabetes vaccine
Diamyd® alone was shown to yield a positive trend (16% effect, p=0.1) in terms
of the patients’ own ability to produce insulin. To achieve a better effect, the
diabetes vaccine is therefore being tested as part of various combination
therapies in several different pilot studies. The efficacy and safety of
initially positive combinations should thereafter be validated in larger studies
in order to be approved as a treatment.

The DIABGAD study comprises approximately 60 patients between the ages of 10 and
18 newly diagnosed with type 1 diabetes, randomized to four treatment groups,
for which C-peptide data is available for 50 patients at 15 months. The first
group received one injection of Diamyd® 20µg on two occasions four weeks apart
combined with ibuprofen over the course of 90 days, in addition to vitamin D for
a period of 15 months; the second group received one injection of Diamyd® 20µg
on two occasions four weeks apart combined with vitamin D for a period of 15
months; the third group received a double dose of Diamyd® four weeks apart and
vitamin D for 15 months and; the fourth group received placebo only. Enrollment
in the study, which is double-blind, randomized and placebo-controlled,
commenced in February 2013. All participants have now been monitored for 15
months of the 30-month total for the study.

About Diamyd Medical

Diamyd Medical is dedicated to finding a cure for autoimmune diabetes through
pharmaceutical development and investments in stem cell and medical technology.

Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy
(ABT) based on the exclusively licensed GAD-molecule. The Company’s licensed
technologies for GABA and Gliadin have also potential to become key pieces of
the puzzle of a future solution to prevent, treat or cure autoimmune diabetes,
and also certain inflammatory diseases. At this time six clinical studies are
ongoing. Diamyd Medical is one of the major shareholders in the stem cell
company Cellaviva AB, active in private family saving of stem cells from the
umbilical cord. Stem cells can be expected to be used in Personalized
Regenerative Medicine (PRM), for example for restoration of beta cell mass in
diabetes patients where the autoimmune component of the disease has been
arrested by ABT.

Six researcher-initiated clinical studies with Diamyd® in different treatment
regimens are ongoing:

  · DIABGAD- 1 – COMBINING DIAMYD® WITH VITAMIN D AND IBUPROFEN

INTERVENTION TRIAL

A placebo-controlled trial, where Diamyd® is being tested in combination with
vitamin D and ibuprofen. The trial comprises approximately 60 patients between
the ages of 10 and 18, recently diagnosed with type 1 diabetes, and will
continue for a total of 30 months. The aim of the combination treatment is to
preserve the body’s own capacity to produce insulin. The trial runs at nine
clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping
University, Sweden. 30 month results from the trial are due during the first
half year of 2017.

  · DIAGNODE -1 –DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D

INTERVENTION TRIAL

An open label trial, where Diamyd® is administered directly into lymph nodes in
combination with treatment with vitamin D. The trial comprises five patients
between the ages of 18 and 30 newly diagnosed with type 1 diabetes, and will
continue for a total of 30 months. The aim of the trial is to evaluate the
safety of the combination treatment and the effect on the immune system and the
patients’ insulin producing capacity. The trial is led by Professor Johnny
Ludvigsson at Linköping University, Sweden. The first patient was included in
the trial in February 2015.

  · GABA/ DIAMYD® – COMBINING DIAMYD® WITH GABA

INTERVENTION TRIAL

A placebo-controlled trial, where Diamyd® is being tested in combination with
GABA. The trial comprises 75 patients between the ages of 4 and 18 recently
diagnosed with type 1 diabetes, and will continue for a total of 12 months. The
aim of the combination treatment is to preserve the body’s residual capacity to
produce insulin. The trial is led by Professor Kenneth McCormick at the
University of Alabama at Birmingham, USA. The first patient was included in the
trial in March 2015.

  · EDCR IIa – COMBINING DIAMYD® WITH ETANERCEPT AND VITAMIN D

INTERVENTION TRIAL

An open label trial, where Diamyd® is combined with etanercept and vitamin D.
The trial comprises 20 patients between the ages of 8 and 18, newly diagnosed
with type 1 diabetes, and will continue for a total of 30 months. The aim of the
trial is to evaluate the safety of the combination treatment and the effect on
the immune system and the patients’ insulin producing capacity. The trial is led
by Professor Johnny Ludvigsson at Linköping University, Sweden. The first
patient was included in May 2015.

  · DiAPREV-IT 1– DIAMYD®

PREVENTION TRIAL

A placebo-controlled trial, where Diamyd® is being tested in children at high
risk of developing type 1 diabetes, meaning that they have been found to have an
ongoing autoimmune process but do not yet have any clinical symptoms of
diabetes. A total of 50 participants from the age of four have been enrolled in
the trial, which will last for five years. The aim of the trial is to evaluate
whether Diamyd® can delay or prevent the participants from presenting with type
1 diabetes. The trial is led by Dr. Helena Elding Larsson at Lund University,
Sweden. Five year results are expected at the end of 2016.

  · DiAPREV-IT 2 – COMBINING DIAMYD® WITH VITAMIN D

PREVENTION TRIAL

A placebo-controlled trial, where Diamyd® is being tested in combination with
vitamin D in children at high risk of developing type 1 diabetes, meaning that
they have been found to have an ongoing autoimmune process but do not yet have
any clinical symptoms of diabetes. A total of 80 participants between the ages
of 4 and 18 will be enrolled in the trial, which will last for five years. The
aim of the trial is to evaluate whether Diamyd® can delay or prevent the
participants from presenting with type 1 diabetes. The trial is led by Dr.
Helena Elding Larsson at Lund University, Sweden. The first patient was included
in March 2015.

Diamyd Medical’s B-share is traded on Nasdaq Stockholm First North under the
ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, President and CEO
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@diamyd.com
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: info@diamyd.com. Reg. no.: 556242-3797. Website: www.diamyd.com.