Quarterly Report I 17/18

September 2017 – November 2017, Diamyd Medical AB (publ), Fiscal year 2017/2018

September 1, 2017 – November 30, 2017

  • R&D-expenses amounted to MSEK -7.6 (-2.0). The cost increase compared with the previous year relates to the preparation of the DIAGNODE-2 trial and production of GAD-65
  • Net result amounted to MSEK -10.8 (-4.3)
  • Result per share, before and after dilution, amounted to SEK -0.2   (-0.1)
  • Cash flow from operating activities amounted to MSEK -12.1 (-4.7)
  • Liquid assets and short-term investments amounted as of November 30 to MSEK 73.7 (26.4)

Significant events during the reporting period

  • Phase II-trial DIAGNODE-2 open to include patients
  • Results of the investigator-initiated prevention trial DiAPREV-IT 2 is brought forward to 2020
  • The GABA portfolio is strengthened with new license 
  • Strategic development of the study drug RemygenTM
  • Phase II trial DIAGNODE-2 with the diabetes vaccine Diamyd® approved to start in all participating countries 

Significant events after the reporting period

  • The diabetes vaccine Diamyd® shows continued positive clinical course when four patients have been followed for 30 months and when all twelve patients have been followed for six months

CEO comments

Dear Shareholders and Readers,

The last two months were dominated by new and promising results from DIAGNODE-1, the ongoing investigator-initiated trial where the diabetes vaccine Diamyd® is administered to the lymph node in recently diagnosed patients suffering from Type 1 diabetes. The treatment aims to interrupt the immune system’s attack on the insulin-producing cells and in this way preserve the remaining endogenous insulin production at the time of diagnosis. The value of such treatment is considerable for both patients and society, as even a minor ability to produce insulin means patients find it easier to manage their blood sugar levels, which can substantially reduce future complications, such as cardiovascular diseases, renal failure and impaired vision. In addition, the risk of acute hypoglycemia, meaning low blood sugar that may lead to unconsciousness or at worst a fatal outcome, may be decreased if some of the patient’s endogenous insulin producing capacity is being preserved.

All twelve patients participating in the DIAGNODE-1 trial have now been followed for 6 months, half of the patients for 15 months and four for 30 months since start of the trial, and we can now see a disease progression suggesting the vaccine is slowing down the immune system’s destruction of the insulin-producing cells. At 6 months, the average decrease of the patients’ own insulin production measured as the stimulated C-peptide was 1.7 % (compared with 15 % in untreated patients of the same age according to published research), at 15 months 10.8% (compared with 35%), and at 30 months 32% (compared with 50% or more). This is in line with observations in our own previous trials with patients receiving placebo, inactive treatment. In the ongoing investigator initiated DIAGNODE-1, patients are on average injecting less insulin compared to at the start of the trial, and maintaining better blood sugar levels, which provides further confirmation of results suggesting that the intralymphatic treatment with the vaccine has a positive and long-term effect on the disease progression. Previously published immunological data  also shows that intralymphatic treatment produces a strong and desired immunological response.

Our highest priority now is DIAGNODE-2, the follow-up placebo-controlled Phase II trial comprising a total of 80 patients, where our goal is to complete enrollment within 12 months. The first DIAGNODE-2 clinic opened for enrollment in mid-November and 15 out of 17 clinics in Sweden, Spain and the Czech Republic are now open. Information about the trial is given not only by the different clinics but also through campaigns in social media and in local newspapers.

Our commitment toward our shareholders is to increase the value of your investment. I would like to thank you for your trust and look forward to reporting on the progress of our ongoing projects.

Stockholm, January 24, 2018
Ulf Hannelius,
President and CEO


Significant events during the reporting period

Phase II-trial DIAGNODE-2 open to include patients
The diabetes vaccine Diamyd®for intralymphatic administration will be delivered to the clinics participating in the pivotal trial DIAGNODE-2 that can begin screening patients. The trial comprises about 80 patients from Spain, the Czech Republic and Sweden 12–24 diagnosed with type 1 diabetes during the last 6 months.

The results of the investigator-initiated prevention trial DiAPREV-IT 2  is brought forward to 2020
The Swedish Medical Products Agency approves a change to the trial led by Associate Professor Helena Elding Larsson, Lund University, where the diabetes vaccine Diamyd®is administered subcutaneously and vitamin D orally to a group of individuals at high risk of being diagnosed with type 1 diabetes. The change entails that the recruitment will stop at 26 children instead of 80 children and that the childrens’ metabolic and immunological parameters will be followed in total for 2 years after the first injection instead of 5 years.

The GABA portfolio is strengthened with new license 
Diamyd Medical concludes a new exclusive licensing agreement with University of California, Los Angeles (UCLA) Technology Development Group on behalf of UC Regents. The license relates to new patent applications for the therapeutic use of GABA (gamma-aminobutyric acid) with positive allosteric modulators of the GABAA receptor to enhance beta cell regeneration, survival and immunomodulation.

Strategic development of the study drug RemygenTM
A preliminary patent application is filed on the formulation and release characteristics of the GABA-based study drug RemygenTM. Based on feedback from a scientific meeting with the Swedish Medical Products Agency, and in collaboration with Diamyd Medical’s scientific network, the Company will commence designing the first clinical trial based on RemygenTM.

Phase II trial DIAGNODE-2 with the diabetes vaccine Diamyd® approved to start in all participating countries
Spanish and Czech Competent Authorities and the relevant Ethics Committees approves Diamyd Medical's application to conduct DIAGNODE-2, a pivotal follow-up placebo-controlled Phase II trial with the diabetes vaccine Diamyd®to be tested in children and young adults recently diagnosed type 1 diabetes. Previously, the trial has been approved by the Swedish Medical Products Agency and the Ethics Committee.

Significant events after the reporting period

The diabetes vaccine Diamyd® shows continued positive clinical course after 30 months and when all patients have been followed for 15 months
Positive effects such as lower insulin requirements and improved blood glucose levels are observed for the first four diabetes patients that have been followed for 30 months in the DIAGNODE-1 trial. Safety looks good and no serious side effects have been reported.

Positive results are also reported from the trial when all patients have been followed for 6 months. A clinically relevant and positive progression can be demonstrated in terms of the body’s own capacity to produce insulin, as well as long-term blood sugar and insulin dose. No serious adverse events have been reported.
 

On-going clinical trials with Diamyd®

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 diabetic patients is of utmost importance. The diabetes vaccine Diamyd® has been used in clinical trials with more than 1 000 patients and has shown a good safety profile. Diamyd® is easy to administer in any clinical setting. The potential annual market is estimated to several billion dollars per year. Five clinical trials are ongoing combining Diamyd® with various other immunomodulatory compounds; etanercept, vitamin D and GABA.

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

An open label trial, where Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The trial comprises twelve patients between the ages of 12 and 30 newly diagnosed with type 1 diabetes and will continue for a total of 30 months. The trial was fully recruited in June 2017. 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.

  • DIAGNODE -2 – DIAMYD® IN LYMPH GLANDS IN COMBINATION WITH VITAMIN D

DIAGNODE-2 is a follow-up double-blind randomized trial where Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The trial encompasses approximately 80 patients from Sweden, the Czech Republic and Spain, aged 12–24 years that have recently been diagnosed with type 1 diabetes. The patients are followed for 15 months. The trial is a follow up of DIAGNODE-1. The aim of the trial is to evaluate the patients’ remaining insulin producing capacity. Coordinating Investigator is Professor Johnny Ludvigsson at Linköping University. Diamyd Medical is the Sponsor of the trial.

  • GABA/ DIAMYD® – COMBINING DIAMYD® WITH GABA

A placebo-controlled trial, where Diamyd®is given subcutaneously and being tested in combination with GABA. In accordance with agreement with Jansen Research & Development and JDRF the trial has expanded to comprise 95 patients between the ages of 4 and 18 recently diagnosed with type 1 diabetes. The trial 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.

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

An open label trial, where Diamyd®is given subcutaneously and being tested in combination with etanercept and vitamin D. The trial comprises 20 patients between the ages of 8 and 18 who have been 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. 15-month results are expected during the first quarter of 2018.

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

A placebo-controlled trial, where Diamyd® is given subcutaneously and 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. The trial includes 26 children. 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 above is an excerpt from the report. To read the complete report, please visit www.diamyd.com, or see attached PDF ***

For more 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: info@diamyd.com Reg. no: 556242-3797

This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08.15 CET on January 24, 2018.

Note: This document has been prepared in both Swedish and English. The Swedish version shall govern in case of differences between the two documents. The document contains certain statements about the Company’s operating environment and future performance. These statements should only be regarded as reflective of prevailing interpretations. No guarantees can be made that these statements are free from errors.


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