Tesomet för behandling av Prader-Willis syndrom - Saniona

Saniona Updates Tesomet Clinical Development Timelines

2021-03-15 1 day ago In late April, Saniona announced positive preliminary results from its phase II study with Tesomet in HO. In addition to the results showing that Tesomet was safe and well tolerated, robust efficacy data with statistically significant improvements in body weight loss, waist circumference and glycaemic control were also presented. 2021-03-08 2020-04-22 Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. 2021-03-03 2018-06-07 Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. Saniona achieved positive top-line Phase 2 results from the open-label extension study of Tesomet in patients with HO. Patients treated with Tesomet for nearly one year (24 weeks in a double-blind trial followed by a 24-week open label extension) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in 2021-03-08 Saniona har fått klartecken av amerikanska läkemedelsmyndigheten FDA att utföra en säkerhetsstudie inom hjärta-kärl som en del av bolagets kliniska utvecklingsprogram för Tesomet inom hypotalamisk fetma. Studien sträcker sig över en kortare period, ett par månader, och inkluderar cirka 300 patienter.

Saniona tesomet

Idag bedrivs forskning och utveckling inom läkemedel för behandling av diverse nervsjukdomar och autoimmuna sjukdomar. Läkemedelsportföljen är bred och innefattar läkemedel i olika kliniska faser. En stor del av arbetet utförs i samarbete med andra aktörer inom läkemedelsbranschen. 2021-03-15 · Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att data från bolagets kliniska Fas 2-studie med Tesomet på hypotalamisk fetma (HO) kommer att presenteras vid Endocrine Societys årsmöte 2021 (ENDO 2021), vilket avhålls virtuellt 20-23 mars 2021. 8 Mar 2021 Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity · PRESS RELEASE. behavior, body composition and metabolic parameters Status: Phase IIa started Milestone: Phase IIa data (2018) Alex Himes tesofensine/metoprolol Tesomet 11 Mar 2021 Saniona is also evaluating Tesomet for the treatment of Prader-Willi syndrome ( PWS) and plans to begin a Phase IIb trial in this indication in the 3 Mar 2021 Tesomet (Saniona) is an investigational, fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, View the latest Saniona AB (SANION) stock price, news, historical charts, analyst Saniona Announces Oral Presentation of Tesomet Data in Hypothalamic 24 Nov 2020 Saniona: Tesomet Potential Reinforced and that tesomet holds the potential as a potential efficacious treatment in this indication, in our view. Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity.

Saniona Updates Tesomet Clinical Development Timelines

Prövningsläkemedlet Tesomet är en fastdoskombination av tesofensin (en trefaldig monoaminåterupptagshämmare) och metoprolol (en beta-1-selektiv blockerare). Saniona avancerar Tesomet för behandling av hypotalamisk fetma och Prader-Willis syndrom, två allvarliga och sällsynta störningar som kännetecknas av fetma och störd aptitreglering. Prövningsläkemedlet Tesomet är en fastdoskombination av tesofensin (en trefaldig monoaminåterupptagshämmare) och metoprolol (en beta-1-selektiv blockerare). Saniona avancerar Tesomet för behandling av hypotalamisk fetma och Prader-Willis syndrom, två allvarliga och sällsynta störningar som kännetecknas av fetma och störd aptitreglering.

Redeye: Saniona - Tesomet - A Potential Goldmine - Mangold

Saniona mottar pre-IND-besked från FDA om den regulatoriska hanteringen av Tesomet för Prader-Willis syndrom (PWS) och hypotalamisk Saniona meddelar att data från studien med Tesomet på hypotalamisk fetma kommer att presenteras muntligt under ENDO 2021. Posted on Sanionas användning av Tesomet, en kombination av Tesofensine och Metoprolol, har haft en positiv inverkan på provpatienter som deltagit i Saniona presenterade nyligen övertygande fas 2a-data för Tesomet vid behandling av kraftigt överviktiga patienter med skadad hypotalamus. Redeye: Saniona – Tesomet – A Potential Goldmine. Read more in the research update by Anders Hedlund: https://bit.ly/35xgqaG. läkemedelskandidaten Tesomet kommer att användas utanför sitt indikationsområde för hypotalamisk fetma, så kallad ”off-label” användning. Den 21 september 2020 avslutas nyttjandeperioden för Sanionas teckningsoptioner av serie TO 2 som kan stärka bolaget med cirka 37 Mkr Saniona rapporterar topplinjeresultat från Tesomet Fas 2a interimstudien i Prader-Willis syndrom. Saniona, ett ledande bioteknikföretag inom Saniona går in i andra delen av Fas 2a-studien med Tesomet för Prader-Willis syndrom baserat på positiva resultat hos vuxna patienter.
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Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. Saniona (OMX: SANION), a biotech company focused on CNS and eating disorders, today reported an update on its ongoing dose-finding Phase 2a study of Tesomet in adolescent patients with Prader-Willi syndrome (PWS). Saniona is preparing to initiate a Phase 2b study of Tesomet in PWS in the first half of this year. Orphan drug designation is a special status granted by the FDA to medicines and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and 2020-04-22 Saniona previously evaluated Tesomet in a randomized, double-blind, placebo-controlled Phase 2a trial in adults and adolescents with PWS. Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a clinically meaningful reduction in … Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced positive top-line results from the Phase 2 open-label extension study of Tesomet in Saniona has announced results from its 24-week double blind, randomized, placebo-controlled Phase 2 trial evaluating the safety and efficacy of Tesomet in patients with hypothalamic obesity (HO).

Saniona, ett ledande bioteknikföretag inom Saniona går in i andra delen av Fas 2a-studien med Tesomet för Prader-Willis syndrom baserat på positiva resultat hos vuxna patienter. Saniona får särläkemedelsklassning av FDA för Tesomet mot Prader-Willis syndrom. 03 mars 2021 kl 13:00. PRESSMEDDELANDE.
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MFN.se > Saniona > Saniona Updates Tesomet Clinical

Vid fullt nyttjande tillförs Saniona cirka 37 miljoner kronor före emissionskostnader, något som ytterligare stabiliserar finansieringen för utveckling av Tesomet. Rami Levin, vd Saniona Tesomet provides its effect via an established mechanism of action that is relevant to both syndromic and nonsyndromic forms of obesity, providing an avenue to potentially developing the compound across multiple obesity disorders Rami Levin, vd Saniona This is a fantastic milestone for Saniona. Saniona är ett forskningsbolag. Idag bedrivs forskning och utveckling inom läkemedel för behandling av diverse nervsjukdomar och autoimmuna sjukdomar.

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Saniona meddelar att data från studien med - RIZDEX

June 9, 2020 Saniona (OMX: SANION), a clinical-stage biotech company focused on rare diseases, today announced it has completed a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), Office of Neuroscience and Division of Psychiatry Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic obesity and Prader-Willi syndrome, two severe rare disorders characterized by obesity and loss of appetite control. Saniona (OMX: SANION), a biotech company focused on CNS and eating disorders, today reported an update on its ongoing dose-finding Phase 2a study of Tesomet in adolescent patients with Prader-Willi syndrome (PWS). Saniona is preparing to initiate a Phase 2b study of Tesomet in PWS in the first half of this year. Orphan drug designation is a special status granted by the FDA to medicines and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, BCIQ provides accurate information and context to support profitable and strategic decision making. Unlike other intelligence solutions, BCIQ exclusively supports the unique needs of the biopharma industry and 2020-04-22 Saniona previously evaluated Tesomet in a randomized, double-blind, placebo-controlled Phase 2a trial in adults and adolescents with PWS. Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a clinically meaningful reduction in … Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced positive top-line results from the Phase 2 open-label extension study of Tesomet in Saniona has announced results from its 24-week double blind, randomized, placebo-controlled Phase 2 trial evaluating the safety and efficacy of Tesomet in patients with hypothalamic obesity (HO).