|End-of-day quote - 03/04|
Quarterly Report I 20/21
|01/20/2021 | 02:16am|
Figures in parentheses relate to the corresponding period previous financial year.
· Net result: MSEK 104.9 (-6.8). The increase compared to previous year is a one-off effect of corresponding MSEK 117.5 due to profit from divestment of shares in
· Result per share:
· Cash flow from operating activities: MSEK -14.1 (-6.1)
· Cash and cash equivalents at
Significant events first quarter,
· Phase IIb topline results demonstrated a significant treatment effect of Diamyd[®] in a predefined genetic patient group covering about 40-50% of all type 1 diabetes patients
· Analyses of prevention trials and intralymphatic pilot trial with the diabetes vaccine Diamyd[®] supported a positive efficacy trend in genetically defined groups of type 1 diabetes patients
Significant events after the reporting period
· Positive safety evaluation of Remygen[®] in high dose and in combination with Alprazolam gave the go-ahead for the continuation of the ReGenerate-1 trial
· Meta-analysis updated with DIAGNODE-2 results provided further support for a precision medicine approach using Diamyd[®]
· Immunological analysis of Phase IIb trial with Diamyd[®] showed differences between genetically defined patient groups
· An additional
Comments by CEO
Following the announcement of the topline results from the phase IIb trial DIAGNODE-2 with Diamyd[®] in
The notion that individuals carrying certain HLA genotypes have a very high likelihood of responding to Diamyd[® ]treatment has received further support from the recently updated meta-analysis that we announced last week. The analysis now includes the data from DIAGNODE-2 and encompasses data from 627 individuals that have participated in randomized clinical trials with Diamyd[®].
The findings from the analysis show that the two variables that influence the clinical effect of Diamyd[®] the most are 1) the HLA genotype and 2) the dosing regimen. This is comforting additional knowledge to what we already knew about our diabetes vaccine, as we can control for both factors when designing and conducting trials. It is also reassuring that baseline glycemic values, in other words the patient's blood glucose and insulin dose at study start, do not seem to influence the positive effect of Diamyd[®].
In addition, as we announced in December, the first immunological results from DIAGNODE-2 also showed significant differences between the genetically defined patient groups. The collected genetic and immunological insights support the possibility that we may be able to truly individualize the treatment through tailored trials and using real world data.
I am pleased to see that our other programs are advancing according to plan. For the Remygen[®] (GABA) activities, the first ReGenerate-1 trial participants have been treated for a month with high dose Remygen[®] and the combination of Remygen[®] and Alprazolam, and the safety committee has given the greenlight for the trial to proceed as planned. Our manufacturing facility we are establishing in Umeå is being received very positively by the local life science community which gives us a great opportunity to find top talent to join our company. I am also pleased with our strong cash position, which is especially due to the proceeds that we have received through the sale of Companion Medical, Inc. to Medtronic. This puts us in a good position to advance all our operations.
In parallel to the significant scientific advances, it is very promising that the JDRF, a leading global organization funding type 1 diabetes research, has launched a screening education and awareness campaign in
Significant events during the first quarter
The pro rata share corresponded to approximately
In connection to the acquisition of Companion Medical, Inc. by
Phase IIb topline results demonstrated a significant treatment effect of Diamyd[®] in a predefined genetic patient group covering about 40-50% of all type 1 diabetes patients
Analyses of prevention trials and intralymphatic pilot trial with the diabetes vaccine Diamyd[®] supported a positive trend in genetically defined groups of type 1 diabetes patients
A combined analysis of two previous clinical prevention trials, DiAPREV-IT 1 and 2 in healthy children at high risk of type 1 diabetes, as well as additional insights from the open label pilot trial DIAGNODE-1 in children and young adults newly diagnosed with type 1 diabetes, while not reaching statistical significance, were consistent with the recently published large-scale responder analysis which showed a highly significant and clinically relevant effect of the diabetes vaccine Diamyd[®] in individuals positive for genotypes that include HLA DR3-DQ2.
Significant events after the reporting period
Positive safety evaluation of Remygen[®] in high dose and in combination with Alprazolam gave the go-ahead for the continuation of the trial
Following evaluation of safety data, an independent safety committee (DSMB) recommended the continuation of the investigator-initiated clinical trial ReGenerate-1, where
Meta-analysis updated with DIAGNODE-2 results provided further support for a precision medicine approach using Diamyd[®]
The large scale meta-analysis, previously published in
Immunological analysis of Phase IIb trial with Diamyd[®] showed differences between genetically defined patient groups
The first immunological results from DIAGNODE-2 showed that the immune response differed significantly between genetically defined patient groups for several immunological parameters following treatment with the diabetes vaccine Diamyd[®] (GAD-alum). The results were in line with the earlier observed difference in clinical response (announced in
The project will design, test and build a sustainability framework powered by artificial intelligence (AI) for
A milestone was achieved in connection with the acquisition of
Two drugs in clinical development
Diamyd[®] and Remygen[®] are drugs in clinical development that focus on the underlying disease mechanisms of diabetes; the dysfunction and loss of insulin-producing beta cells in the pancreas.
Diamyd[®] is an antigen-specific immunomodulating diabetes vaccine for the treatment and prevention of autoimmune diabetes (type 1 diabetes and
Clinical data indicate the potential of the diabetes vaccine Diamyd[®] to halt or stop the autoimmune destruction of insulin-producing beta cells. The effect is achieved by antigen-specific reprogramming of immune cells by administration of low doses of Diamyd[®] in superficial lymph nodes. By maintaining the endogenous insulin production, Diamyd[®] has the potential to make a significant difference in the daily life of patients as well significantly reduce the complications of type 1 diabetes. Topline results from the Phase IIb trial DIAGNODE-2 has demonstrated a significant treatment effect of Diamyd[® ]in a predefined genetic patient group.
Remygen[®] is an oral regenerative and immunomodulatory drug candidate for the treatment of autoimmune- and type 2 diabetes. By stimulating the growth of insulin-producing cells, Remygen[®] has the potential to reverse the disease progression in autoimmune- and type 2 diabetes. Based on clinical data, Remygen[®] has also the potential to protect against hypoglycemia by improving the hormonal response. Remygen[®] is now being investigated in a clinical Phase I/II trial (ReGenerate-1), where clinical efficacy is evaluated with the aim of optimizing the treatment regimen ahead of registration-based trials.
Ongoing clinical trials
Type 1 diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a drug that improves the prospects for patients with diabetes is of utmost importance. The effect of intralymphatic administration of Diamyd[®], an antigen-specific immunotherapy aimed at stopping the immune system's attack on insulin-producing beta cells in autoimmune diabetes, is evaluated in the Phase IIb trial DIAGNODE-2 and in the Phase II trial GADinLADA.
Remygen[®], which aims to stimulate the growth of beta cells in patients with diabetes, is evaluated in patients in a Phase I/II trial.
Trials with Diamyd® in lymph node
· DIAGNODE -2 - DIAMYD[®] IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
A follow-up double-blind randomized clinical trial where Diamyd[®] is administered directly into a lymph node with oral supplements of vitamin D. The trial encompasses 109 patients from
· GADinLADA - DIAMYD[®] IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
An open-label, investigator initiated clinical trial where Diamyd[®] is administered directly into a lymph node with oral supplements of vitamin D. The trial, conducted in
Trial with Remygen® (GABA)
· REGENERATE-1 - REMYGEN[®] /ALPRAZOLAM
An open-label, investigator initiated clinical trial with Remygen[®]. The trial includes approximately 36 patients aged 18-50 who have had type 1 diabetes for more than five years with low to non-existing insulin production. Safety and initial efficacy results from the dose escalation section of the trial have paved the way to initiate the main trial and have also demonstrated a potential effect of Remygen[®] to improve the hormonal response to hypoglycemia. The main trial evaluates whether the insulin-producing cells can be regenerated and if the hormonal response to hypoglycaemia can be improved using Remygen[®] and the combination of Remygen[®] and Alprazolam. The trial is led by
Manufacturing of GAD65 in Umeå
A new facility for vaccine manufacturing is being set up in Umeå, the Capital of Västerbotten County in
Further information is available on https://www.diamyd.com.
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