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"Obviously, we had hoped for a different outcome" says Peter Nordkild, CEO of
ABOUT THE STUDY
The phase IIb study was a randomized, double-blind, placebo-controlled study taking place in 14 study centers in
The primary endpoint of the study was calculated from the late luteal phase total symptom score (LmaxSum21), as the difference between the average scores of two baseline cycles and the average score in the treatment cycles. The reduction in these scores was compared between actively treated and placebo treated patients. The average baseline score was 85 points, corresponding to patients having moderate to severe PMDD symptoms. Study treatment reduced the effect score by 27.9 points in the placebo group, compared to 30.3 in the active Sepranolone group, resulting in minimal to mild PMDD symptoms during treatment. The high placebo response may reflect the effect for some study patients of receiving positive attention of their disease having been unrecognized for many years.
In all, more than 2,000 doses of Sepranolone were taken during the study. One out of five patients reported injection site discomfort, no one reported severe discomfort. Overall, study data demonstrate that Sepranolone was well-tolerated with no safety signals.
In summary,
ASARINA PHARMA GOING FORWARD
A webcast with the possibility to ask questions on the results is scheduled at 09.30 CET on
https://tv.streamfabriken.com/2020-04-22-asarina-pharma-press-conference
For further information, please contact:
Peter Nordkild, CEO,
Phone: +45 25 47 16 46
E-mail: peter.nordkild@asarinapharma.com
Phone: +46 8-463 83 00
Mail: certifiedadviser@penser.se
The information above was provided by
About Sepranolone
Sepranolone (ISOALLO) is an active CNS steroid and endogenous compound produced naturally in the brain, especially during stress. It inhibits the effects of Allopregnanolone (ALLO). Following ovulation, progesterone is formed by the corpus luteum to prepare the uterus for a pregnancy. ALLO, a progesterone metabolite that enhances the GABAA system in different regions in the brain, is produced. For women with an altered sensitivity to ALLO this results in the negative mood symptoms of PMDD. ALLO is also produced as part of a stress reaction both in the brain and in the adrenal cortex. Sepranolone (ISOALLO) is the non-hormonally active steroid produced in the brain that inhibits the action of ALLO, so preventing the symptoms of PMDD from emerging. Sepranolone is highly specific, only inhibiting the effect of GABA steroid action on the receptor. It does not influence the effects of any other active GABAA receptor substances. Sepranolone has been demonstrated in animal models of PMDD, and in a clinical pharmaco-dynamic model that evaluated how a new family of compounds influences the GABA mechanisms in the brain. These compounds are called GAMSAs - GABAA Modulating Steroid Antagonists. Sepranolone is a GAMSA. Sepranolone is the first therapy specifically developed to treat PMDD.
About PMDD
Premenstrual dysphoric disorder (PMDD) is a severe neuroendocrinological condition affecting 4-8 percent of women of fertile age worldwide. The condition is often highly socially impairing with cyclical, often personality-altering symptoms that build up in the luteal phase (the two weeks before a period), peak in the week directly before menstruation, and then recede quickly when the period starts. Emotional symptoms include extreme mood changes, severe irritability and/or anger, depression, anxiety and feelings of hopelessness and low self-worth. In
About
We are a Swedish biotech company developing Sepranolone for allopregnanolone-related stress and menstrual cycle neurological disorders. Our product pipeline is built on over 40 years of research into allopregnanolone-related neurological disorders. With our new family of GAMSA compounds (GABAA Modulating Steroid Antagonists) we aim to deliver a new generation of efficacious and safe drugs for still widely untreated neuroendocrinological conditions.
https://news.cision.com/asarina-pharma/r/asarina-pharma-reports-topline-results-from-phase-iib-study-in-pmdd,c3093737
https://mb.cision.com/Main/17069/3093737/1233403.pdf
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