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2021-09-16 Asarina Pharma Asarina Pharma: Administrativ fördröjning hos offentlig myndighet orsakar mindre försening i fas IIa Tourette-studien Pressreleaser Ladda ner | Visa Stäng
2021-09-16 Asarina Pharma Asarina Pharma: Administrative backlog at public authority causes short-term delay in Tourette study Pressreleaser Ladda ner | Visa Stäng
2021-08-19 Asarina Pharma Asarina Pharma AB (publ) Rapport om Q2 2021 Rapporter Ladda ner | Visa Stäng
2021-08-19 Asarina Pharma Asarina Pharma AB (publ) Q2 Report 2021 released Rapporter Ladda ner | Visa Stäng
2021-06-23 Asarina Pharma Asarina Pharma reports topline results in Phase IIa Menstrual Migraine study Pressreleaser Ladda ner | Visa Stäng
Pressreleaser | 23 Jun 2021 | Asarina Pharma

Asarina Pharma reports topline results in Phase IIa Menstrual Migraine study

CEO Peter Nordkild: ”Obviously we had hoped for a different outcome. This solid clinical study unfortunately does not confirm the scientific hypothesis that the pre-menstrual drop in allopregnanolone concentration, so called substance withdrawal syndrome, causes menstrual migraine. We remain committed to continue pursuing the development of Sepranolone for Tourette and Obsessive Compulsive Disorder, and it is vital to understand that the allopregnanolone withdrawal mechanism hypothesized as causing menstrual migraine is fundamentally different to the mechanism triggering Tourette and Obsessive Compulsive Disorder. Therefore, the lack of effect in menstrual migraine does not change the rationale for treatment of Tourette and OCD. Both of these indications, as demonstrated in preclinical effect models, are based on the direct effect of stress-induced allopregnanolone, as opposed to the hormonally induced increase in allopregnanolone in menstrual migraine.”

CMO Märta Segerdahl: ”In total more than 340 women have taken Sepranolone during its clinical development, with no severe adverse effects. We would like to thank all the participating patients for their dedicated participation in the study, and also the investigative sites and CRO collaborators for a very well conducted study. This especially in light of the restrictions incurred by the ongoing pandemic.”

Sepranolone failed to demonstrate a statistically significant reduction in its primary clinical endpoint, the number of days with menstrually related migraine (2 days prior to menstruation and 5 days into the next menstrual cycle), compared to placebo. There were no effects demonstrated in secondary endpoints.  The overall number of migraine days per menstrual period was reduced similarly for placebo and the two dose levels by approximately 1 day (25% reduction) of the menstrual migraine days. The 86 randomized patients had an average age of 38 years, a headache history of 21 years and prior to study treatment they had an average number of menstrual migraine days of 4 days every menstrual cycle.

Sepranolone demonstrated an excellent safety prolife in the study, with more than 1,200 doses of Sepranolone taken. One out of five patients reported some injection site discomfort, such as itching or a mild rash, no one reported severe discomfort. These mild side effects were transient. Overall, study data demonstrate that Sepranolone was well-tolerated with no safety signals.  

About the study

The Phase IIa study was a randomized, double-blind, placebo-controlled study that took place at 7 study centers: 4 in Sweden and 3 in Finland.  164 patients were enrolled, 86 were randomized after completing the screening period. Patients self-administered 0.4 mL injections using a prefilled single-use syringe. Two dose levels were administered subcutaneously, either 10 or 16 mg per dose, or placebo. Treatment began 14 days prior to estimated start of next menstruation, running every second day during the luteal phase up until the beginning of menstruation, with a maximum 7 doses per cycle. Patients filled in a detailed daily treatment assessment, reporting number of days with migraine, intensity of migraine pain, amount of symptomatic treatment taken, and a questionnaire on function and symptoms.

About Menstrual Migraine

Approx. 50 million women worldwide suffer from Menstrual Migraine. Unlike standard episodic migraine, MM attacks are predictable and recurring. MM is defined by the International Classification of Headache Disorders as migraine attacks that start up to two days before menstruation begins, continuing three or more days into the menstrual flow. MM is recognized as highly resistant to standard migraine therapies, including Triptans and CGRP antibodies.

About Sepranolone

Sepranolone is a patented, identical version of isoallopregnanolone – the endogenous neurosteroid that inhibits and regulates allopregnanolone and many of its negative symptoms. Asarina Pharma patented Sepranolone as a pharmaceutical formulation in 2010. Highly GABA-A receptor selective, Sepranolone has achieved an excellent safety profile in repeated studies.

The information above was provided by Asarina Pharma AB according to EU Market Abuse Regulations. The information was provided, through the contact person below, for publication on June 23, 2021 at 1905 CET.

2021-06-23 Asarina Pharma Asarina Pharma rapporterar topline-resultat i fas IIa-studien i menstruell migrän Pressreleaser Ladda ner | Visa Stäng
2021-06-08 Asarina Pharma Asarina Pharma har beviljats patent i USA för Sepranolon för Tourettes syndrom, tvångssyndrom och sjukligt spelberoende Pressreleaser Ladda ner | Visa Stäng
2021-06-08 Asarina Pharma Asarina Pharma granted US patent for Sepranolone for Tourette syndrome, OCD and pathological gambling Pressreleaser Ladda ner | Visa Stäng
2021-05-31 Asarina Pharma Asarina Pharma obtains convertible loan for continued research on neurological conditions including Obsessive Compulsive Disorder Pressreleaser Ladda ner | Visa Stäng
2021-05-31 Asarina Pharma Asarina Pharma får konvertibelt lån för fortsatt forskning inom neurologiska tillstånd inklusive tvångssyndrom Pressreleaser Ladda ner | Visa Stäng
2021-05-28 Asarina Pharma Asarina Pharma: Issuance of 700,000 warrants completed Pressreleaser Ladda ner | Visa Stäng
2021-05-28 Asarina Pharma Asarina Pharma: Utfärdande av 700 000 teckningsoptioner slutförda Pressreleaser Ladda ner | Visa Stäng
2021-05-19 Asarina Pharma Asarina Pharma får godkännande på CTA för fas IIa-studie om Tourettes syndrom Pressreleaser Ladda ner | Visa Stäng
2021-05-19 Asarina Pharma Asarina Pharma receives approval of CTA for phase IIa Tourette study Pressreleaser Ladda ner | Visa Stäng
2021-05-18 Asarina Pharma Asarina Pharma AB (publ) Q1 Report 2021 released Rapporter Ladda ner | Visa Stäng
2021-05-18 Asarina Pharma Asarina Pharma AB (publ) Rapport om Q1 2021 Rapporter Ladda ner | Visa Stäng
2021-04-21 Asarina Pharma Kommuniké från årsstämma i Asarina Pharma AB (publ) Pressreleaser Ladda ner | Visa Stäng
2021-04-21 Asarina Pharma Bulletin from the Annual General Meeting of Asarina Pharma AB (publ) Pressreleaser Ladda ner | Visa Stäng
2021-03-22 Asarina Pharma Asarina Pharma: KALLELSE TILL ÅRSSTÄMMA I ASARINA PHARMA AB (PUBL) Pressreleaser Ladda ner | Visa Stäng
2021-03-22 Asarina Pharma Asarina Pharma: NOTICE OF ANNUAL GENERAL MEETING IN ASARINA PHARMA AB (PUBL) Pressreleaser Ladda ner | Visa Stäng
2021-03-15 Asarina Pharma Asarina Pharma AB (publ) Bokslutskommuniké 2020 publicerad Pressreleaser Ladda ner | Visa Stäng
2021-03-15 Asarina Pharma Asarina Pharma AB (publ) Annual Report 2020 released Pressreleaser Ladda ner | Visa Stäng
2021-02-25 Asarina Pharma Asarina Pharma AB (publ) Q4 / Year End 2020 report released Pressreleaser Ladda ner | Visa Stäng
2021-02-25 Asarina Pharma Asarina Pharma AB (publ) Q4 / Bokslutskommuniké 2020 publicerad Pressreleaser Ladda ner | Visa Stäng
2021-02-11 Asarina Pharma Asarina Pharma: New preclinical study confirms that Sepranolone suppresses tics in Tourette Syndrome Pressreleaser Ladda ner | Visa Stäng
2021-02-11 Asarina Pharma Asarina Pharma: Ny preklinisk studie bekräftar att Sepranolon minskar tics vid Tourettes syndrom Pressreleaser Ladda ner | Visa Stäng
2020-11-25 Asarina Pharma Asarina Pharma AB (publ) Q3 2020 report released Rapporter Ladda ner | Visa Stäng
2020-11-25 Asarina Pharma Asarina Pharma AB (publ) delårsrapport, tredje kvartalet 2020 publicerad Rapporter Ladda ner | Visa Stäng
2020-09-30 Asarina Pharma Asarina Pharmas fas IIa-studie i menstruell migrän fullrekryterad Pressreleaser Ladda ner | Visa Stäng
2020-09-30 Asarina Pharma Asarina Pharma: Full patient enrolment in Phase IIa Menstrual Migraine study Pressreleaser Ladda ner | Visa Stäng
2020-08-19 Asarina Pharma Asarina Pharma AB (publ) Interim Report Q2 2020 released Rapporter Ladda ner | Visa Stäng
2020-08-19 Asarina Pharma Asarina Pharma AB (publ) delårsrapport, andra kvartalet 2020 publicerad Rapporter Ladda ner | Visa Stäng
2020-05-26 Asarina Pharma Asarina Pharma AB (publ) delårsrapport, första kvartalet 2020 publicerad Rapporter Ladda ner | Visa Stäng
2020-05-26 Asarina Pharma Asarina Pharma AB (publ) Interim Report Q1 2020 released Rapporter Ladda ner | Visa Stäng
2020-05-05 Asarina Pharma Asarina Pharma: Beslut vid årsstämman den 5 maj 2020 Pressreleaser Ladda ner | Visa Stäng
2020-05-05 Asarina Pharma Asarina Pharma: Resolutions from the Annual General Meeting, 5 May 2020 Pressreleaser Ladda ner | Visa Stäng
2020-04-21 Asarina Pharma Asarina Pharma reports topline results from Phase IIb study in PMDD Pressreleaser Ladda ner | Visa Stäng
2020-04-21 Asarina Pharma Asarina Pharma meddelar topline-resultat för fas IIb PMDS-studie Pressreleaser Ladda ner | Visa Stäng
2020-04-14 Asarina Pharma Asarina Pharma publicerar årsredovisning för 2019 Pressreleaser Ladda ner | Visa Stäng
2020-04-14 Asarina Pharma Asarina Pharma Annual Report for 2019 released Pressreleaser Ladda ner | Visa Stäng
2020-04-02 Asarina Pharma Asarina Pharma: NOTICE OF ANNUAL GENERAL MEETING IN asarina pharma AB (publ) Pressreleaser Ladda ner | Visa Stäng
2020-04-02 Asarina Pharma Asarina Pharma: KALLELSE TILL ÅRSSTÄMMA i ASARINA PHARMA AB (publ) Pressreleaser Ladda ner | Visa Stäng
2020-03-24 Asarina Pharma Asarina Pharma to release historic Phase IIb PMDD data on schedule Pressreleaser Ladda ner | Visa Stäng
2020-03-24 Asarina Pharma Asarina Pharma kommer släppa fas IIb PMDS-data enligt plan Pressreleaser Ladda ner | Visa Stäng
2020-03-16 Asarina Pharma Asarina Pharmas R&D-dag 2020 nu digital Pressreleaser Ladda ner | Visa Stäng
2020-03-05 Asarina Pharma Inbjudan till Asarina Pharmas R&D-dag 2020 Pressreleaser Ladda ner | Visa Stäng
2020-02-21 Asarina Pharma Asarina Pharma AB (publ) Year-end 2019 Report released Pressreleaser Ladda ner | Visa Stäng
2020-02-21 Asarina Pharma Asarina Pharma lämnar bokslutskommuniké 2019 Pressreleaser Ladda ner | Visa Stäng
2020-02-04 Asarina Pharma SAVE THE DATE: Asarina Pharma R&D Day - Thursday 26 March Pressreleaser Visa Stäng
2020-02-04 Asarina Pharma SAVE THE DATE - Asarina Pharma bjuder in till R&D-dag Pressreleaser Ladda ner | Visa Stäng
2020-02-04 Asarina Pharma SAVE THE DATE - Asarina Pharma Hosting R&D Day Pressreleaser Ladda ner | Visa Stäng
2020-01-21 Asarina Pharma Asarina Pharma's extraordinary general meeting Pressreleaser Ladda ner | Visa Stäng
2020-01-21 Asarina Pharma Asarina Pharmas extra bolagsstämma Pressreleaser Ladda ner | Visa Stäng
2019-12-20 Asarina Pharma Asarina Pharma: KALLELSE TILL EXTRA BOLAGSSTÄMMA I ASARINA PHARMA AB (PUBL) Pressreleaser Ladda ner | Visa Stäng
2019-12-20 Asarina Pharma Asarina Pharma: NOTICE OF EXTRAORDINARY GENERAL MEETING IN ASARINA PHARMA AB (PUBL) Pressreleaser Ladda ner | Visa Stäng
2019-12-05 Asarina Pharma Asarina Pharma: First patient dosed in landmark Menstrual Migraine study Pressreleaser Ladda ner | Visa Stäng
2019-12-05 Asarina Pharma Asarina Pharma: Första dos i historisk fas IIa-studie i menstruell migrän Pressreleaser Ladda ner | Visa Stäng
2019-11-20 Asarina Pharma Asarina Pharma AB (publ) Interim Report Q3 2019 released Rapporter Ladda ner | Visa Stäng
2019-11-20 Asarina Pharma Asarina Pharma AB (publ) delårsrapport Q3 2019 publicerad Rapporter Ladda ner | Visa Stäng
2019-10-24 Asarina Pharma Asarina Pharma har genomfört en riktad nyemission om cirka 48 MSEK Pressreleaser Ladda ner | Visa Stäng
2019-10-24 Asarina Pharma Asarina Pharma has completed a directed share issue of approximately SEK 48 million Pressreleaser Ladda ner | Visa Stäng
2019-10-23 Asarina Pharma Asarina Pharma avser att genomföra en riktad nyemission Pressreleaser Ladda ner | Visa Stäng
2019-10-23 Asarina Pharma Asarina Pharma intends to carry out a directed share issue Pressreleaser Ladda ner | Visa Stäng
2019-08-28 Asarina Pharma Asarina Pharma: First patient included in menstrual migraine study Pressreleaser Ladda ner | Visa Stäng
2019-08-28 Asarina Pharma Asarina Pharma: Första patienten inkluderad i menstruell migränstudie Pressreleaser Ladda ner | Visa Stäng
2019-08-20 Asarina Pharma Asarina Pharma AB (publ) delårsrapport, andra kvartalet 2019 publicerad Rapporter Ladda ner | Visa Stäng
2019-08-20 Asarina Pharma Asarina Pharma AB (publ) Interim Report Q2 2019 released Rapporter Ladda ner | Visa Stäng
2019-08-15 Asarina Pharma Asarina Pharma: Sista patienten inkluderad i unik PMDS-studie Pressreleaser Ladda ner | Visa Stäng
2019-08-15 Asarina Pharma Asarina Pharma: Last Patient In for landmark PMDD study Pressreleaser Ladda ner | Visa Stäng
2019-07-09 Asarina Pharma Asarina Pharma: Sepranolone receives FDA IND approval in menstrual migraine Pressreleaser Ladda ner | Visa Stäng
2019-07-09 Asarina Pharma Asarina Pharma: Sepranolone får IND-godkännande från FDA i menstruell migrän Pressreleaser Ladda ner | Visa Stäng
2019-06-03 Asarina Pharma Asarina Pharma AB (publ) utfärdar nya aktier till Ergomed plc Pressreleaser Ladda ner | Visa Stäng
2019-06-03 Asarina Pharma Asarina Pharma issues new shares to Ergomed plc Pressreleaser Ladda ner | Visa Stäng
2019-05-20 Asarina Pharma Asarina Pharma AB (publ) delårsrapport första kvartalet 2019 publicerad Rapporter Ladda ner | Visa Stäng
2019-05-20 Asarina Pharma Asarina Pharma AB (publ) Interim Report, Q1 2019 released Rapporter Ladda ner | Visa Stäng
2019-05-08 Asarina Pharma Decisions from Annual General Meeting of Asarina Pharma, 8 May 2019 Pressreleaser Ladda ner | Visa Stäng
2019-05-08 Asarina Pharma Asarina Pharma: Beslut vid årsstämman den 8 maj 2019 Pressreleaser Ladda ner | Visa Stäng
2019-04-23 Asarina Pharma Asarina Pharma Clinical Trial featured on BBC Pressreleaser Ladda ner | Visa Stäng
2019-04-17 Asarina Pharma Asarina Pharma publicerar årsredovisning för 2018 Pressreleaser Ladda ner | Visa Stäng
2019-04-17 Asarina Pharma Asarina Pharma Annual Report for 2018 released Pressreleaser Ladda ner | Visa Stäng
2019-04-11 Asarina Pharma Asarina Pharma Beslutsförslag avseende styrelsen inför årsstämman 2019 Pressreleaser Ladda ner | Visa Stäng
2019-04-11 Asarina Pharma Asarina Pharma Proposals regarding the Board of Directors for the Annual General Meeting 2019 Pressreleaser Ladda ner | Visa Stäng
2019-04-05 Asarina Pharma Asarina Pharma: KALLELSE TILL ÅRSSTÄMMA i ASARINA PHARMA AB (publ) Pressreleaser Ladda ner | Visa Stäng
2019-04-05 Asarina Pharma Asarina Pharma: NOTICE OF ANNUAL GENERAL MEETING IN ASARINA PHARMA AB (publ) Pressreleaser Ladda ner | Visa Stäng
2019-04-02 Asarina Pharma Asarina Pharma shows efficacy of Sepranolone in Tourette's syndrome on par with current first line treatment, but without side effects Pressreleaser Ladda ner | Visa Stäng
2019-04-02 Asarina Pharma Asarina Pharma shows efficacy of Sepranolone in Tourette's syndrome on par with current first line treatment, but without side effects Pressreleaser Ladda ner | Visa Stäng
2019-04-02 Asarina Pharma Asarina Pharma shows efficacy of Sepranolone in Tourette's syndrome on par with current first line treatment, but without side effects Pressreleaser Ladda ner | Visa Stäng
2019-02-25 Asarina Pharma Asarina Pharma Year-End Report 2018 shows solid progress Rapporter Ladda ner | Visa Stäng
2019-02-25 Asarina Pharma Asarina Pharma bokslutskommuniké för 2018 visar kvartal med stadiga framsteg Rapporter Ladda ner | Visa Stäng
2018-11-22 Asarina Pharma Asarina Pharma CSO presents at PMS event in Stockholm: `It's time to talk about PMDD' Pressreleaser Ladda ner | Visa Stäng
2018-11-14 Asarina Pharma Interim Report July-September 2018 Rapporter Ladda ner | Visa Stäng
2018-11-14 Asarina Pharma Delårsrapport juli-september 2018 Rapporter Ladda ner | Visa Stäng
2018-10-24 Asarina Pharma Asarina Pharma over-allotment option fully exercised as stabilization period of share offering ends Pressreleaser Ladda ner | Visa Stäng
2018-10-24 Asarina Pharma Ingen stabilisering av aktier i Asarina Pharma efter noteringen, övertilldelningsoption utnyttjas till fullo Pressreleaser Ladda ner | Visa Stäng
2018-10-23 Asarina Pharma Asarina Pharma sponsrar PMS-dagen i Stockholm. "Kvinnors hälsa påverkar oss alla, det är hög tid börja prata om PMDS". Pressreleaser Ladda ner | Visa Stäng
2018-10-23 Asarina Pharma Asarina Pharma sponsrar PMS-dagen i Stockholm. "Kvinnors hälsa påverkar oss alla, det är hög tid börja prata om PMDS". Pressreleaser Ladda ner | Visa Stäng
2018-10-23 Asarina Pharma Asarina Pharma sponsors PMS Day Stockholm `Women's health affects all of us, it's time to talk about PMDD' Pressreleaser Ladda ner | Visa Stäng

Kommande händelser

14 Nov 2018 | Kvartalsrapport 2018-Q3
25 Feb 2019 | Bokslutskommuniké 2018
8 May 2019 | Årsstämma 2018
9 May 2019 | Årligutdelning
20 May 2019 | Kvartalsrapport 2019-Q1
20 Aug 2019 | Kvartalsrapport 2019-Q2
21 Jan 2020 | Extrastämma 2019
28 Feb 2020 | Bokslutskommuniké 2019
5 May 2020 | Årsstämma 2019
6 May 2020 | Årligutdelning
26 May 2020 | Kvartalsrapport 2020-Q1
19 Aug 2020 | Kvartalsrapport 2020-Q2
25 Nov 2020 | Kvartalsrapport 2020-Q3
25 Feb 2021 | Bokslutskommuniké 2020
21 Apr 2021 | Årsstämma 2020
22 Apr 2021 | Årligutdelning
18 May 2021 | Kvartalsrapport 2021-Q1
19 Aug 2021 | Kvartalsrapport 2021-Q2
25 Nov 2021 | Kvartalsrapport 2021-Q3

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