A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi center, 16-week Dose finding, Safety and Efficacy Study with Open-label Extension Period of Tesomet in Adult and Adolescent Subjects with Prader-Willi Syndrome

开始日期2022-01-03

申办/合作机构-

NCT05198362 / Withdrawn临床2期

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.

开始日期2021-12-28

申办/合作机构

Saniona AB

NCT05147415 / Withdrawn临床2期

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity

This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO

开始日期2021-11-11

申办/合作机构

Saniona AB

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100 项与特索芬辛/酒石酸美托洛尔相关的专利（医药）

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项与特索芬辛/酒石酸美托洛尔相关的文献（医药）

2022-06-01·European Journal of Endocrinology1区 · 医学

Randomized controlled trial of Tesomet for weight loss in hypothalamic obesity

1区 · 医学

Article

作者: Drejer, Jørgen ; Klose, Marianne ; Krogsgaard, Kim ; Madsbad, Sten ; Astrup, Arne Vernon ; Edsberg, Berit ; Feldt-Rasmussen, Ulla ; Byberg, Sarah ; Huynh, Kim ; Aharaz, Abdellatif ; Magkos, Faidon ; Tfelt-Hansen, Jacob

Context Hypothalamic injury often leads to rapid, intractable weight gain causing hypothalamic obesity, which is associated with increased risk of cardiovascular and metabolic morbidity and mortality. There are no approved or effective pharmacological treatments for hypothalamic obesity, and conventional lifestyle management remains ineffective.Objective To investigate the safety and efficacy of Tesomet (0.5 mg tesofensine/50 mg metoprolol) in adults with hypothalamic obesity.Methods Twenty-one adults with hypothalamic obesity (16 females) were randomized to Tesomet (0.5 mg/50 mg) or placebo for 24 weeks. Patients also received diet/lifestyle counselling. The primary endpoint was safety; secondary endpoints included measures of body weight, appetite scores, quality of life, and metabolic profile.Results Eighteen patients completed 24 weeks. Consent withdrawal, eligibility, and serious adverse events (SAE) unrelated to treatment resulted in dropouts. One patient experienced a Tesomet-related SAE of exacerbated pre-existing anxiety leading to treatment discontinuation. Tesomet-related adverse events were otherwise mostly mild and included sleep disturbances (Tesomet 50%, placebo 13%), dry mouth (Tesomet 43%, placebo 0%), and headache (Tesomet 36%, placebo 0%). No significant differences in heart rate or blood pressure were observed between groups. Compared to placebo, Tesomet resulted in additional mean (95% CI) weight change of −6.3% ((−11.3; −1.3); P = 0.017), increased the number of patients achieving ≥5% weight loss (Tesomet 8/13, placebo 1/8; P = 0.046), and tended to augment the reduction in waist circumference by 5.7 cm ((−0.1; 11.5); P = 0.054).Conclusion Tesomet was welltolerated, did not affect heart rate or blood pressure, and resulted in significant reductions in body weight compared to placebo in adults with hypothalamic obesity.

项与特索芬辛/酒石酸美托洛尔相关的新闻（医药）

2022-12-20

·PRNewswire

DelveInsight Estimates a Promising Picture of Obesity Pipeline Space Landscape as Key 100+ Pharma Companies Working in the Space

The prevalence of obesity has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Obesity and the growing research and development activities to develop novel therapies to treat obesity drive the market. The Companies developing the potential therapies in the last stage of development include Novo Nordisk, Eli Lilly and Company, Saniona, and several others. LAS VEGAS, Dec. 20, 2022 /PRNewswire/ -- DelveInsight's ' Obesity Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline obesity therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the obesity pipeline domain. Key Takeaways from the Obesity Pipeline Report DelveInsight's obesity pipeline report depicts a robust space with 100+ active players working to develop 130+ pipeline therapies for obesity treatment. Key obesity companies such as 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others are evaluating new drugs for obesity to improve the treatment landscape. Promising obesity pipeline therapies in various stages of development include Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. In December 2022, Amgen announced new Phase I data from AMG 133. This first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of AMG 133 in people with obesity and without diabetes (NCT04478708). The MAD cohorts showed mean percent changes in body weight (BW), ranging from -7.2% at the lowest dose (140mg Q4W), to -14.5% at the highest dose (420mg Q4W) by day 85. A substantial degree of weight loss was maintained beyond the treatment period, which will be shared as part of the oral presentation. Most treatment-emergent adverse events (TEAEs) were mild and transient. The majority of the TEAEs were GI-related, with the most common being nausea and vomiting, most events resolved within 48 hours. In December 2022, Poolbeg Pharma, a clinical-stage infectious disease company, acquired the exclusive license from InsuCaps to use its proprietary microencapsulation and nanoencapsulation oral delivery technologies in metabolic syndrome-related diseases, including obesity, pre-diabetes, and diabetes. In November 2022, Rhythm Pharmaceuticals, Inc. announced that Great Britain's Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older. In November 2022, Reviva Pharmaceuticals Holdings, Inc. announced the issuance of a patent covering the composition of matter for RP1208 in Canada, adding to its existing protection in key markets around the world. The Canadian patent covers the compositions of novel phenylcycloalkylmethylamine derivatives and the use of the compositions for the treatment of obesity, related co-morbid conditions, and depression and related co-morbid conditions. In October 2022, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity or overweight with weight-related comorbidities. In September 2022, Rivus Pharmaceuticals Inc. announced the completion of a USD 132 million Series B financing led by RA Capital Management with participation from Bain Capital Life Sciences, BB Biotech AG, and existing investors Longitude Capital, Medicxi, and RxCapital. This financing will further support the clinical advancement of lead candidate HU6, a first-in-class Controlled Metabolic Accelerator (CMA) designed to treat cardio-metabolic disease by addressing obesity, a primary driver of disease. In June 2022, LG Chem's new drug for treating genetic obesity received additional ODD (Orphan Drug Designation) from the US FDA. LG Chem announced on the 16th that the FDA recently granted ODD to ' LB54640' for the treatment of 'POMC (Proopiomelanocortin) deficiency.' In April 2022, Saniona announced that it paused the Phase IIb clinical trials testing Tesomet for people with Prader–Willi syndrome (PWS) and hypothalamic obesity (HO). The decision "is not related to the safety or efficacy of Tesomet and is entirely due to funding limitations. The company also announced a reprioritization and restructuring effort to immediately reduce operating expenses while maximizing cash resources. Request a sample and discover the recent advances in obesity drug treatment @ Obesity Pipeline Report The obesity pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage obesity drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the obesity clinical trial landscape. Obesity Overview Obesity is a chronic disease that causes abnormal or excessive fat accumulation or adipose tissue in the body, posing a health risk. It is caused by an imbalance between calories consumed and calories burned. The factors responsible for the causes of obesity include heredity, a sedentary lifestyle, excessive fat, sugar consumption (energy-dense meals), certain medications, and endocrine issues. Changes in the environment or society, as well as in behavior and culture, all directly impact. Obesity symptoms go beyond an increase in body fat. It can cause skin issues, shortness of breath, sleeping difficulties, and other symptoms. Some obesity symptoms have even been linked to an increased risk of developing certain diseases and disorders. In some cases, these can be life-threatening or even fatal. Find out more about drugs for obesity @ FDA-approved Obesity Drugs A snapshot of the Obesity Pipeline Drugs mentioned in the report: Learn more about the emerging obesity pipeline therapies @ Obesity Clinical Trials Obesity Therapeutics Assessment The obesity pipeline report proffers an integral view of obesity emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Obesity Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Glucagon like peptide 1 receptor agonists, Gastric inhibitory polypeptide receptor agonists, Beta 1 adrenergic receptor antagonists, Biogenic monoamine uptake inhibitors, Lipolysis modulators, Alpha-glucosidase inhibitors, Amylase inhibitors, Lipase inhibitors, Glucagon like peptide 1 receptor agonists, Glucagon receptor agonists, Islet amyloid polypeptide replacements Key Obesity Companies: 180 Life Sciences, 9 meters, Aardvark Therapeutics, Adocia, Agentix, AgeX Therapeutics, Altimmune, Amgen, Antag Therapeutics, Aphaia Pharma, Aptorum Group, AstraZeneca, Bukwang Pharmaceutical, Caliway Biopharmaceutics Co Ltd, Can Fite Biopharma, Carmot Therapeutics, Inc., Cellivery Therapeutics Inc, CinFina Pharma, Clayton Biotech, Click Therapeutics, Corbus Pharma, DiscoveryBiomed Inc, Dong-A ST, Dongkook Pharmaceuticals, Eccogene, Elevian, Eli Lilly and Company, Empros Pharma, Enterin Inc., EraCal Therapeutics AG, ERX Pharmaceuticals, ERX Pharmaceuticals, Eternygen GmbH, Eurofarma, Gannex Pharma, Glaceum, Gmax Biopharm, GPER G-1 Development Group, LLC, Gubra Therapeutics, Hanmi Pharmaceutical, Hanmi Pharmaceuticals, Innovent Biologics, Jenrin Discovery, Jiangsu Hansoh Pharmaceutical, Kallyope, Kintai Therapeutics, Kriya Therapeutics, LG Life Sciences, Lipidio Pharmaceuticals, MakScientific, Nano Precision Medical, NeonMind Biosciences, Novartis, Novo Nordisk, NuSirt Biopharma, Otsuka Pharmaceutical Factory Inc, Pfizer, Raziel Therapeutics, Reata Pharmaceuticals, Regeneron Pharmaceuticals, Reviva Pharmaceuticals, Rivus Pharmaceuticals, Shionogi, SHIONOGI & Co., Ltd., Sigrid Therapeutics, SJT Molecular Research SL, Structure Therapeutics, Sun Pharmaceutical Industries, Techfields Pharma, Terns Pharmaceuticals, Tonix Pharmaceuticals, UGISense AG, Versanis Bio, Viking Therapeutics, YSOPIA Bioscience, Yuhan, Zealand Pharma, and others. Key Obesity Pipeline Therapies: Semaglutide oral, Tirzepatide, Sibutramine/Topiramate, NNC0174-0833, Tesomet, SHR-20004, RZL-012, CT-868, PF-06882961, EMP-16, S-237648, LY3502970, ARD-101, NNC0165-1875, XW003, IBI362, TG103, Cotadutide, MBL949, PF-07081532, APHD-012, LY 3437943, HSG4112, Leucine/sildenafil, BI 456906, Pemvidutide, LY3841136, HM15136, GMA106, DD01, ZP8396, K833, NNC0480-0389, LB54640, CT-181, CB4211, CT-388, CIN-109, ERX-1000, DWP306001, SCO-094, S-309309, NO-13065, GDD3898, XW004, SCO-267, ASC41, AMG 133, LY3541105, AMG-786, HU6, BMS-963272, BI 1820237, Xla 1, Dapiglutide, PB-119, PB-718, AGTX-2004, ECC5004, Thermostem, XW017, HM 14320, TNX-2900, CF-102, XW 010, LR19020, LR19056, YH34160, NM-136, CIN 110, CIN 209, CIN 210, RSVI-301, PramExe, BC GlueExe, BC Pram GlueExe, AGEX BAT1, CLS-1, CRB-913, Tespria, AM 6545, LP-003, KT A522, JD5037, SJT4a, GL0034, TF0103, TERN-601, NEO-001, KTX 0200, ENT-03, Bimagrumab, VK2735, HUM-234, NPM 139, YHC2129, YHC2134, YHC1140, GSBR-2nd Gen, GSBR-3rd Gen, and others. Dive deep into rich insights for new drug for obesity treatment; visit @ Obesity Medications Table of Contents For further information on the obesity pipeline therapeutics, reach out @ Obesity Drug Treatment Related Reports Obesity Epidemiology Forecast Obesity Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the obesity epidemiology trends. Obesity Market Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, among others. Hypothalamic Obesity Market Hypothalamic Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. Hypothalamic Obesity Pipeline Hypothalamic Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key hypothalamic obesity companies, including Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, among others. HET Obesity/POMC Deficiency Obesity Pipeline HET Obesity/POMC Deficiency Obesity Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. HET Obesity/POMC Deficiency Obesity Market HET Obesity/POMC Deficiency Obesity Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key HET obesity/POMC deficiency obesity companies, including Novo Nordisk, Eli Lilly, and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | CAR-T Pipeline Insight | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Outlook Report | Crows Feet Market Insight | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market Related Healthcare Blogs Obesity: A Global Concern Weight Loss and Obesity Market Obesity Treatment Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

临床1期孤儿药快速通道临床2期引进/卖出

2022-11-25

·GlobeNewswire-Health Care

Saniona AB’s Nomination Committee for the Annual General Meeting 2023

PRESS RELEASE November 25, 2022 Saniona (OMX: SANION), a clinical stage biopharmaceutical company, today announced the composition of the Nomination Committee for the Annual General Meeting 2023. Pursuant to the instruction and charter for the Nomination Committee adopted by the general meeting, the Nomination Committee shall comprise of three members, which shall be the Chairman of the Board of Directors and two members appointed by the two largest shareholders as of last September. On September 30, 2022, the two largest shareholders, who desired to appoint a representative to the Nomination Committee, were Jørgen Drejer and Dan Peters. Each such shareholder has appointed a representative, as shown below, who together with the Chairman of the Board of Directors will form Saniona AB’s Nomination Committee. The Nomination Committee’s members are: John Haurum, professional board member for life science companies and former CEO of F-star Biotechnology Limited, Cambridge, UK, appointed by Jørgen DrejerSøren Skjærbæk, Partner at Ursus law firm, Vejle, Denmark, appointed by Dan PetersJørgen Drejer, Chairman of Saniona AB’s Board The Nomination Committee shall prepare and submit proposals to the Annual General Meeting 2023 regarding: election of the Chairman at the Annual General Meetingelection of the Chairman and other members of the Board;remuneration for the Chairman and for each of the other members of the Board and, if applicable, remuneration for committee work;election of the auditor and the auditor’s remuneration; andprinciples for appointing the Nomination Committee. The instruction and charter for the Nomination Committee in Saniona AB can be found in the Corporate Governance section at the company’s website, www.saniona.com. Saniona AB’s Annual General Meeting will be held on Thursday May 25, 2023 in Malmö. The Nomination Committee’s proposals will be presented in the notice to the Annual General Meeting and on the company’s web site. Shareholders who would like to submit proposals to the Nomination Committee can do so via e-mail to clo@saniona.com marked “Recommendation to the Nomination Committee” or by ordinary mail to the address: Recommendation to the Nomination CommitteeSaniona ABSmedeland 26BDK-2600 GlostrupDenmark To ensure that the proposals can be considered by the Nomination Committee, proposals shall be submitted in due time before the Annual General Meeting, but not later than February 25, 2023. For more information, please contact Thomas Feldthus, CEO, +45 22109957; thomas.feldthus@saniona.comThe information was submitted for publication, through the agency of the contact person set out above, at 15:30 CET on 25 November 2022.About Saniona Saniona is a clinical-stage biopharmaceutical company focused on the discovery and development of medicines modulating ion channels. The company’s most advanced product candidate, Tesomet™, has been progressed to mid-stage clinical trials for rare eating disorders. Through its ion channel expertise, Saniona is advancing two product candidates, SAN711 and SAN903. SAN711 has successfully completed a Phase 1 clinical trial for the treatment of neuropathic pain conditions. SAN903 is ready for Phase 1 clinical studies for the treatment of inflammatory and fibrotic disorders. The company has research and development partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cephagenix ApS. Saniona is based in Copenhagen, Denmark, and listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com. Attachment 20221125 Nomination committee

临床1期

2022-11-17

·GlobeNewswire-Health Care

Saniona publishes its interim report for the third quarter of 2022

Three Months Ended September 30, 2022 (2021)Nine Months Ended September 30, 2022 (2021)Revenue was SEK 2.4 M (2.3 M)Revenue was SEK 12.0 M (7.6 M)Operating profit/loss was SEK 21.8 M (-88.2 M)Net profit/loss was SEK 17.5 M (-93.7 M)Operating profit/loss was SEK -203.1 M (-286.7 M)Net profit/loss was SEK -204.4 M (-281.8 M)Basic earnings/loss per share was SEK 0.28 (-1.50)Basic earnings/loss per share was SEK -3.28 (-4.52)Diluted earnings/loss per share were SEK 0.28 (-1.50)Diluted earnings/loss per share were SEK -3.28 (-4.52) Business highlights in Q3 2022 On August 16, Saniona progressed its Kv7 ion channel epilepsy program into lead optimization phase, the last drug discovery phase before potential drug candidate selection.On September 30, Saniona extended its runway and amended the loan agreement with Formue Nord. The loan was extended with 7 months and the maturing date of the loan has been changed from June 30, 2023, to January 31, 2024. Significant events after the reporting period On November 3, Saniona announced that SAN903 is ready to start the regulatory process for entering Phase 1 clinical trials. Comments from the CEO “We continue to make progress on our partnering efforts and development of our pipeline in Q3 while we have reduced costs and extended runway until 2024 without having to raise additional financing. Saniona has a broad pipeline of products, a highly motivated and professional team and significant experience with partnering. I am confident that our business development efforts will help us through this difficult period for listed biotech companies and that our pipeline will deliver new valuable breakthrough medicine.” For more information, please contact Thomas Feldthus, CEO, +45 22109957; thomas.feldthus@saniona.comThis information is such information as Saniona AB (publ) 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 8.00 CET on 17 November 2022.About Saniona Saniona is a clinical-stage biopharmaceutical company focused on the discovery and development of medicines modulating ion channels. The company’s most advanced product candidate, Tesomet™, has been progressed to mid-stage clinical trials for rare eating disorders. Through its ion channel expertise, Saniona is advancing two product candidates, SAN711 and SAN903. SAN711 has successfully completed a Phase 1 clinical trial for the treatment of neuropathic pain conditions. SAN903 is ready for Phase 1 clinical studies for the treatment of inflammatory and fibrotic disorders. The company has research and development partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cephagenix ApS. Saniona is based in Copenhagen, Denmark, and listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com. Attachment 20221117 Saniona Q3 (UK)

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100 项与特索芬辛/酒石酸美托洛尔相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
普拉德-威利综合症	临床2期	美国	Saniona AB	2021-12-28
下丘脑性肥胖症	临床2期	美国	Saniona AB	2021-11-11
2型糖尿病	临床2期	德国	Saniona AB	2016-04-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03149445 (2016-003694-18, CTgov)	临床2期	普拉德-威利综合症	18	Tesomet (Tesomet 0.50/50 mg)	齋顧膚夢鹹遞簾廠願製(醖膚鏇衊齋壓積鹹繭壓) = 襯鬱壓鹹齋夢觸廠鬱構醖構獵廠鹹積鹽構餘鏇 (窪簾淵構網蓋壓齋鑰醖, 網構網艱醖糧鏇鹹範鹹 ~ 餘鹽夢鏇艱襯憲鏇膚壓) 更多	-	2024-02-26
				Placebo (Placebo (Adult))	齋顧膚夢鹹遞簾廠願製(醖膚鏇衊齋壓積鹹繭壓) = 廠壓衊繭積壓壓醖構鏇醖構獵廠鹹積鹽構餘鏇 (窪簾淵構網蓋壓齋鑰醖, 願築鬱鬱艱構淵膚糧構 ~ 鬱膚鏇簾鹽選築構網衊) 更多
NCT03286829 (CTgov)	临床1期	-	60	Tesomet (Tesomet "High Dose" in Fasted Condition)	構繭糧觸選鑰衊鏇鏇繭(醖窪積糧襯積構簾鹽鏇) = 淵齋衊顧蓋鬱鏇觸選夢糧製壓鹽獵選襯築鹽製 (遞製淵願簾醖廠製築淵, 構蓋鹽構窪糧鑰衊築範 ~ 繭餘膚範齋壓餘遞構遞) 更多	-	2020-05-14
				Tesomet (Tesomet "Low Dose" in Fasted Condition)	構繭糧觸選鑰衊鏇鏇繭(醖窪積糧襯積構簾鹽鏇) = 遞鹹憲範鹽簾範膚網衊糧製壓鹽獵選襯築鹽製 (遞製淵願簾醖廠製築淵, 願淵鹹願鑰繭繭壓願糧 ~ 艱鹽鑰鹽糧夢構膚膚鏇) 更多
NCT02737891 (CTgov)	临床2期	2型糖尿病	60	Tesofensine/Metoprolol (Tesofensine/Metoprolol)	觸蓋鏇蓋網願蓋醖糧願(醖襯繭簾憲糧積糧鬱衊) = 壓艱膚蓋膚壓築鏇簾積選繭鏇窪壓膚構廠餘網 (構鹽憲膚糧鹽襯顧鹹醖, 鹽網積衊壓餘膚簾獵觸 ~ 齋憲鹽糧壓鹽膚鏇蓋鏇) 更多	-	2020-05-14
				Placebo (Placebo)	觸蓋鏇蓋網願蓋醖糧願(醖襯繭簾憲糧積糧鬱衊) = 觸夢範壓衊淵壓鬱構鬱選繭鏇窪壓膚構廠餘網 (構鹽憲膚糧鹽襯顧鹹醖, 鏇壓襯襯製鹽齋簾醖窪 ~ 選艱餘遞憲艱夢願壓網) 更多