Diamyd puts focus on pain projects and reduces costs
Diamyd Medical AB is concentrating its resources on the Company's drug
candidates for the treatment of pain and diseases of the nervous system.
The termination of the Phase III program with the diabetes therapy
Diamyd® means significantly lower costs for the Company which creates
strategic leeway.
The primary development focus of Diamyd Medical is shifted from the
diabetes therapy Diamyd® to the Company's portfolio of drug candidates
for the treatment of chronic pain. The pain portfolio is based on the
patented technology Nerve Targeting Drug Delivery System (NTDDS). NTDDS
represents a new type of treatment that delivers gene-based drugs
directly to nerve cells, providing a local effect in the cells targeted
by the treatment. Besides pain relief the technology has potential to be
used for the treatment and prevention of diseases in the nervous system,
such as neuropathy, erectile dysfunction (impotence), neurodegenerative
diseases and cancer. Research and development of NTDDS is mainly being
carried out by the subsidiary Diamyd, Inc. in Pittsburgh, USA.
Results from a Phase II study with the furthest developed drug
candidate, NP2 Enkephalin for the treatment of severe cancer pain, is
expected around year end. At the same time the next drug candidate in
the portfolio, NG2 GAD for the treatment of diabetes pain for instance,
is planned to be ready to enter clinical phase, the phase of drug
development which comprises studies in humans. The portfolio also
includes several projects in earlier stages of development.
“The shift of the Company's primary development focus to the unique
NTDDS technology gives us a fresh start before fall,” says Peter
Zerhouni, President and CEO of Diamyd Medical. “The next milestone will
be the results from the Phase II trial with NP2 Enkephalin, which we
hope will establish proof of principle for this new method of treating
pain as well as the entire NTDDS platform.”
The two parallel Phase III studies with the diabetes therapy Diamyd® in
Europe and the US are being closed since Diamyd®, as previously
reported, did not demonstrate sufficient efficacy neither in the
European Phase III study nor in a similar, smaller study conducted by
the research consortium TrialNet. Diamyd Medical is also terminating
most of the employees in Sweden since they have mainly worked on the
Phase III studies with Diamyd® and in related areas. The Phase III
program with Diamyd® has accounted for approximately two thirds of the
Company's costs which will, consequently, decrease substantially going
forward. The Company expects to have approximately SEK 400 million in
liquid assets at the end of the calendar year.
“Through strict cost control we safeguard our favourable financial
position, which represents a strength in the current turmoil of the
capital markets,” says Peter Zerhouni. “Having plenty of cash on hand
gives us valuable strategic leeway, not least when we get the results
from the Phase II study with NP2 Enkephalin.”
The interest in Diamyd® and the active substance GAD65 is still high
among diabetes researchers. GAD65 plays an important role in type 1
diabetes and continues to have potential to be used against the disease.
Important discussions are ongoing within the research field about why
the studies with Diamyd® did not meet the endpoints and how lessons
learned from these and other studies in type 1 diabetes can guide the
future development of GAD65 towards a diabetes drug. One approach being
tested is to treat earlier in the disease process, before the onset of
the disease. An externally funded and researcher-initiated Phase II
study with Diamyd® is ongoing since 2008 in order to prevent type 1
diabetes in children at high risk of developing the disease, and that
study continues. Other potential ways forward are giving more or higher
doses of Diamyd®, or combining Diamyd® treatment with other drugs.
Work still remains in analyzing the large amounts of data collected in
the Phase III studies with Diamyd® and new data is still being
collected. To complete the safety database of the US Phase III study and
in consultation with the US Food and Drug Administration (FDA), the
Company has decided to follow the patients who received injections of
Diamyd®, but not the ones who received placebo, for six months after the
last injection. The last follow-up visit is planned to take place in
December. In the European Phase III-study, all of the patient visits
have been completed.
For more information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
press@diamyd.com (press@diamyd.com)
Phone: +46 8 661 0026
