Oppretter en tråd for dette selskapet. Har tatt en lyttepost her og håper noen med innsikt kan belyse caset.
Presentasjon av selskapet
Diamyd Medical AB: Diamyd Medical updates on DIAGNODE-2 and upcoming Phase III trial with the diabetes vaccine Diamyd[®]
The database for the European Phase IIb trial DIAGNODE-2 where the diabetes vaccine Diamyd[®] (rhGAD65 / alum) is given directly into the lymph node will be closed within the next few days. As previously announced, the top line results from the trial are expected to be presented at the end of September. The results from DIAGNODE-2 will affect the final design of the upcoming Phase III trial with Diamyd[®] regarding study population and route of administration.
When the database has been locked, the code will be broken and the data analyzed by an external statistician. The main results of DIAGNODE-2 will include both the primary clinical efficacy end-point; endogenous insulin production measured as stimulated C-peptide, and the most important secondary clinical end-points; long-term blood sugar measured as HbA1c, insulin dose and insulin-adjusted HbA1c. The results will be presented for the entire patient population as well as for the genetically defined subgroup HLA-type DR3-DQ2, which was identified in a previously reported meta-study based on three previous clinical trials, recently published in the scientific journal Diabetologia.
“We have the advantage of having access to large amounts of efficacy and safety data from all previous clinical trials that have evaluated the diabetes vaccine Diamyd”, says Ulf Hannelius, CEO of Diamyd Medical. “The DIAGNODE-2 results will give us the opportunity to, together with these data and our insights on subgroups, route of administration and dosage, optimize the design of the upcoming phase III trial clinically and commercially”.
Ongoing planning for the Phase III trial takes into account three possible main tracks: 1) intralymphatic administration of Diamyd[®] in individuals with newly diagnosed type 1 diabetes, 2) intralymphatic administration of Diamyd[®] in individuals with newly diagnosed type 1 diabetes and with HLA type DR3-DQ2, and 3) subcutaneous administration of Diamyd[®] in individuals with newly diagnosed type 1 diabetes and with HLA type DR3-DQ2. In light of the previously announced positive clinical results following an extra intralymphatic injection in the pilot trial DIAGNODE-1 as well as the dose-response relatonship identified in the recent Diabetologia publication, the possibility of giving an additional injection of Diamyd[®] is also being evaluated.
The patient population and route of administration in the Phase III trial will be decided after the results of DIAGNODE-2 have been analyzed. What will be evaluated is whether 1) data provide support for an effect in the entire patient population, 2) data show that an effect is driven by the genetically defined subgroup and whether 3) data provide support for intralymphatic administration leading to further improved effect in the genetically defined subgroup compared to subcutaneous administration. In addition to clinical data, regulatory, commercial and manufacturing-specific aspects will also be considered in the final design of the trial.
The placebo-controlled trial DIAGNODE-2 encompasses 109 patients from Spain, the Czech Republic, Sweden and the Netherlands, aged 12-24 years. The patients, recently diagnosed with type 1 diabetes, have been given the diabetes vaccine Diamyd[®] (or its placebo) directly into the lymph node on three occasions, one month apart, in combination with oral vitamin D (or its placebo) during four months, starting 30 days prior to the first injection. The patients have been followed for 15 months with the aim to evaluate the remaining insulin producing capacity. As of the autumn of 2019, patients who had not yet completed their last visit at 15 months were offered to participate in an extension of the study for another 9 months. Coordinating Investigator is Professor Johnny Ludvigsson at Linköping University. Sponsor for the trial is Diamyd Medical. For more information about the trial, see www.diagnode-2.com.
Har også en relativt liten post her, kjøpt for noen måneder tilbake. Mitt inntrykk er at Diamyd virkelig representerer cutting edge innenfor diabetes, og faktisk utvikler en potensiell “kur” for denne sykdommen. Dvs behandling sinker og reverserer forløpet for noen pasienter. Her er det altså snakk om å behandle den underliggende sykdommen, ikke bare å holde den under kontroll med insulin. Kunstig insulin var revolusjonerende når det kom for 100+ år siden, men så har det ikke skjedd så mye nytt siden.
Dette gjelder type 1 diabetes og en form for diabetes 2 som heter LADA. Tenker nå på lead product som også heter diamyd. Dette er uansett et kjempestort marked, så markedspotensialet burde være solid.
De får jo en readout fra fase IIb nå i september. Så med gode resultater kan de til og mwd søke om en CMA. Har ihvertfall sett folk spekulere i dette på Avanza. Skal muligens tas med en klype salt. Kan også nevnes at selskapet har en relativt lang forhistorie, inkludert en tidligere fase 3. Mener jeg har lest at de har behandlet opp mot 1000 pasienter med Diamyd. Det har altså vært en lang vei, men nå har man endelig skjønt hvilke subtyper diamyd er effektiv mot pluss at man administrerer via lymfeknuter, som gir bedre effekt. Ok, dette ble kanskje litt usammenhengende, men håper det kan stimulere nysgjerrigheten hos noen.
Data i slutten av måneden
Limer inn meldingen også:
Phase IIb topline results demonstrate a significant treatment effect of Diamyd® in a previously identified genetic subgroup of individuals with type 1 diabetes
Diamyd Medical today announced the topline results from the placebo-controlled Phase IIb trial DIAGNODE-2, where the diabetes vaccine Diamyd® (GAD-alum) was injected directly into a lymph node in individuals with recently diagnosed type 1 diabetes. In line with previous large-scale analysis of trials involving subcutaneous administration of Diamyd®, the reults, encompassing a total of 109 patients, showed a statistically significant effect in the predefined HLA (Human Leukocyte Antigen) subgroup of trial participants. Specifically, this trial demonstated a preservation of beta cell function at 15 months post-diagnosis, as measured by meal stimulated C-peptide. The primary endpoint, defined as meal stimulated C-peptide in the entire trial population was not met. Importantly, no related severe adverese events were observed in the trial. Based on these results, Diamyd Medical will pursue the HLA restricted responder subgroup in an upcoming pivotal Phase III program.
“I am very pleased and these results make perfect sense and are alligned with all our previous data”, says Ulf Hannelius, CEO of Diamyd Medical. “Supported by these positive results and the superior safety profile, we will now move forward with a Phase III program in this patient population, representing close to one-half of all individuals with type 1 diabetes”.
“I am overjoyed by the positive results”, says Johnny Ludvigsson, Professor at Linköping University and Coordinating Investigator of the trial. “What we see now is that the GAD treatment works for nearly half of the patients with type 1 diabetes. It is important that this patient group may soon benefit from an effective, safe and convenient treatment that does not suppress the immune system, especially now in the era of COVID-19.”
103 out of 109 patients were evaluated as part of the topline results for the primary endpoint: preserving beta cell function at 15 months, as measured by meal stimulated C-peptide. 55 individuals of the 103 patients evaluated received active treatment while 48 received placebo treatment. 46 patients out of 103 evaluated were positive for the HLA DR3-DQ2 haplotype; a genetically predefined subgroup of high responding patients identified based on data from previous trials focusing on subcutaneous administration of Diamyd®. Out of the 46 patients, 29 received active treatment and 17 received placebo.
While a limited positive but non-significant treatment effect was observed in the 103 patients evaluated as part of the topline results, a statistically significant (p < 0.01) treatment effect was observed in the predefined subgroup of patients positive for HLA DR3-DQ2. In this subgroup of patients, more than 50% greater preservation of C-peptide was observed in those that received active treatment compared to placebo. Likewise, positive trends in patients positive for HLA DR3-DQ2 were observed for all the important secondary endpoints; change in blood glucose levels as determined by HbA1c (an important marker of diabetes management), insulin dose and insulin-adusted HbA1c compared to placebo treated patients. No benefit was seen in patients negative for HLA DR3-DQ2.
“In my 37 years in type 1 diabetes research, these are some of the most promising results I have seen in terms of the potential for providing benefit to those recently diagnosed with type 1 diabetes,” says Mark Atkinson, Ph.D., Director of the Diabetes Research Institute at the University of Florida and Diamyd Medical Board Member. “These findings emphasise the importance of genetic analysis and personalized medicine in the development of treatments for type 1 diabetes and could explain conflicting results of previous trials in the field.”
A short presentation of the results will be given [today at 18:00 ](calendar:T5:today at 18:00 )CET, at https://tv.streamfabriken.com/2020-09-14-press-conference or dial in; SE [+46 856642651 PIN: 20322624#](tel:+46 856642651 PIN: 20322624#), UK [+44 3333000804 PIN: 20322624#](tel:+44 3333000804 PIN: 20322624#), US [+18558570686 PIN: 20322624#](tel:+18558570686 PIN: 20322624#)
On Thursday September 17 at 15:00 CET, CEO Ulf Hannelius, Professor Johnny Ludvigsson and Professor Mark Atkinson invite you to a webcast presentation of the results.
The double-blind, placebo-controlled, European phase IIb trial DIAGNODE-2 included 109 patients aged 12–24 years from 18 clinics in Spain, the Czech Republic, Sweden and the Netherlands. The patients included in the trial were those with new-onset type-1 diabetes and diagnosed within 6 months of therapeutic intervention, along with their having a fasting C-peptide of ≥0.12 nmol/l. These patients were given the diabetes vaccine Diamyd® (or placebo) directly into a lymph node, following ultrasound guidance, on three occasions at one-month intervals. The trial participants were also given oral vitamin D (or placebo) supplements for four months, with vitamin D supplementation started 30 days before the first injection of Diamyd®. The patients were followed for 15 months in order to evaluate their endogenous insulin production, as measured by C-peptide. Of the initial 109 patients who entered the trial, 107 patients completed all visits up to 15 months; only two patients chose to terminate the trial prematurely. Of these 107 patients, 103 patients were available for evaluation of the primary endpoint. Four samples could not be analyzed since they arrived late at the laboratory or because the tests could not be performed on the patient. Of the 103 patients, 46 were positive for the HLA DR3-DQ2 haplotype. From the Autumn of 2019, patients who had not yet completed their last visit at 15 months were offered to participate in an extension of the trial for another 9 months. 53 patients agreed to participate in the extension trial and 15 of these patients have already been followed for 24 months. Results of this extended trial should be available in Q3 2021. Coordinating Investigator of the trial is Professor Johnny Ludvigsson at Linköping University. The Sponsor of the trial is Diamyd Medical.
About Diamyd Medical
Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results has been shown in a genetically predefined subgroup in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB and has holdings in the medtech company Companion Medical, Inc., San Diego, USA.
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; phone: [+46 8-528 00 399](tel:+46 8-528 00 399), e-mail: [email protected].
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: [+46 736 35 42 41](tel:+46 736 35 42 41)
E-mail: [email protected]
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: [+46 8 661 00 26](tel:+46 8 661 00 26), Fax: [+46 8 661 63 68](tel:+46 8 661 63 68)
E-mail: [email protected] Reg. no.: 556242-3797 Website: https://www.diamyd.com
This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 17.25 CET on [September 14, 2020](calendar:T2:September 14, 2020).
Blir spennende med børsåpning i morgen. Skulle tro denne går nærmere 100% . Massiv derisking av produktet og CEO sier 'clear path forward '. Det er vel dagens understatement.
Tror det blir en helt rå oppgang i morgen. Skal ikke se bort ifra av vi snuser på 65+:rocket:
Litt lite profft at de la ut melding før sluttauksjonen var ferdig
Og resultatet var bare positivt for HLA pasienter (som ventet)
Hey. Ja det var en litt merkelig beslutning Men blir bra rally på denne nå.
Kun opp 10 - 15%, synes det var lite. Har kjøpt litt til, ser på dette som en kjøpsanledning.
Opp 20% så langt i dag. Den kan gjerne gå opp til 60 SEK i det tempoet.
Så, studien var mislykket, men de fant en undergruppe som viste effekt?
Efter resultatet höjer vi vårt till 85-95 kr (25-30). Diamyds adresserbara marknad krymper ca 50%, då vaccinet enbart fungerar på de som tillhör den specika subgruppen, från ca USD 90 mdr till USD 45 mdr. Samtidigt höjer vi sannolikheten att substansen tar sig till marknad från 20% till 46%. Vi räknar med att bolaget under nästa år kommer välja en partner, vilket kommer att nansiera den pivotala studien.
Diamyd Medical AB: Diamyd Medical has received USD 13.9 million in connection with its divestment in Companion Medical
Diamyd Medical announces today that in connection with the previously announced acquisiton of Companion Medical, Inc by Medtronic plc., Diamyd Medical has now received approximately USD 13.9 million, corresponding to SEK 120 million. Depending on achievement of certain future milestones, some additional payments may be possible, and will then be communicated if they occur.
DIAMYD MEDICAL: SER RATIONELLT UTFALL AV FAS 2B-STUDIE - VD
STOCKHOLM (Nyhetsbyrån Direkt) Forskningsbolaget Diamyd Medical lyckades inte nå sitt primära mål i Diagnode 2-studien, men lyckades ändå nå signifikans i en genetisk delgrupp av de undersökta patienterna. Det primära målet handlade om ett bevarande av betacellfunktionen 15 månader efter diagnos, mätt genom måltidsstimulerad C-peptid vid behandling av typ 1-diabetes.
“Det här är kanske det mest vetenskapligt rationella resultatet vi kunde få. Man hoppas alltid att det ska fungera i hela gruppen, men den här pilotstudien pekade åt det här hållet”, säger Diamyd Medicals vd Ulf Hannelius till Nyhetsbyrån Direkt.
Med utfallet från den meta-analys som Diamyd Medical tidigare har sett kom utfallet av Diagnode 2-resultatet inte som någon större överraskning.
“Det vi nu ser är att vi i en prospektiv studie kan validera de här retrospektiva analyserna. Givet det hade vi lagt in de här subgruppsanalysen som en predefinierad analys i statistiska analysprotokollet”, säger Ulf Hannelius.
Ungefär hälften av alla patienter med typ 1-diabetes tillhör den berörda genetiska subgruppen där Diamyd Medical nu har sett signifikant bevarande av betacellerna.
Resultaten innebär att Diamyd har potential att bli en så kallad precisionsmedicin.
Diamyd Medical - Intervju Erik Penser Bank - 15 september 2020
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