SANION Saniona AB

Saniona Initiates Multiple Ascending Dose Stage of SAN711 Phase 1 Clinical Trial

Saniona Initiates Multiple Ascending Dose Stage of SAN711 Phase 1 Clinical Trial

PRESS RELEASE

February 10, 2022

Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today provided an update on progress in its Phase 1 clinical trial of SAN711. The company reported that it has now also initiated the multiple ascending dose stage of the trial. The study is placebo-controlled, and the data remain blinded. Saniona continues to expect data from the trial by the end of the first half of 2022.

“We are encouraged to have enrolled and dosed participants in multiple cohorts of the single ascending dose stage of the SAN711 Phase 1 clinical trial and to have now also initiated the multiple ascending dose stage,” said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. “We continue to expect topline data from this study by the end of the first half of this year.”

The Phase 1 clinical trial is a randomized, placebo-controlled study being conducted in approximately 80 healthy volunteers. The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, as evaluated through the single ascending dose and multiple ascending dose phases of the study. The secondary objective is to measure binding to target receptors, as assessed during a positron emission tomography (PET) evaluation phase of the study. More information is available at .

SAN711 is an investigational, potential first-in-class positive allosteric modulator of GABA-A α3 receptors and may be applicable in the treatment of rare neuropathic disorders. It is the first novel molecule derived from Saniona’s proprietary ion channel drug discovery engine to be advanced into internal clinical trials.

For more information, please contact

Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email:

The information was submitted for publication, through the agency of the contact person set out above, at 8:00 CET on 10 February 2022.

About Saniona

Saniona is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for patients suffering from rare diseases for which there are a lack of available treatment options. The company’s lead product candidate, Tesomet™, is in mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, serious rare disorders characterized by severe weight gain, disturbances of metabolic functions and uncontrollable hunger. Saniona has developed a proprietary ion channel drug discovery engine anchored by IONBASE™, a database of more than 130,000 compounds, of which more than 20,000 are Saniona’s proprietary ion channel modulators. Through its ion channel expertise, Saniona is advancing two wholly-owned ion channel modulators, SAN711 and SAN903. SAN711 is in a Phase 1 clinical trial and may be applicable in the treatment of rare neuropathic disorders, and SAN903 is in preclinical development for rare inflammatory, fibrotic and hematological disorders. Led by an experienced scientific and operational team, Saniona has an established research organization in the Copenhagen area, Denmark, and a corporate office in the Boston, Massachusetts area, U.S. The company’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at .

Attachment



EN
10/02/2022

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Saniona AB

Saniona AB: 1 director

A director at Saniona AB sold 502,628 shares at 14.205SEK and the significance rating of the trade was 72/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly sho...

 PRESS RELEASE

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

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 larg...

 PRESS RELEASE

Saniona AB:s valberedning inför årsstämman 2023

Saniona AB:s valberedning inför årsstämman 2023 PRESSMEDDELANDE 25 november 2022 Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling, tillkännager idag valberedningens sammansättning inför årsstämman 2023 Enligt instruktionen och arbetsordningen för valberedningen som antagits av bolagsstämman ska valberedningen bestå av tre ledamöter, vilka ska vara styrelsens ordförande samt två ledamöter utsedda av de två största aktieägarna per den sista september. Den 30 september 2022 var de två största ägarna som önskar utse en representant till valberedningen Jørgen Drejer ...

 PRESS RELEASE

Saniona publishes its interim report for the third quarter of 2022

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 (-...

 PRESS RELEASE

Saniona publicerar sin delårsrapport för det tredje kvartalet 2022

Saniona publicerar sin delårsrapport för det tredje kvartalet 2022   Q3 2022 (Q3 2021)Jan–sep 2022 (jan–sep 2021)Intäkter uppgick till 2,4 MSEK (2,3 M)Intäkter uppgick till 12,0 MSEK (7,6 M)Rörelseresultat uppgick till 21,8 MSEK (-88,2 M)Periodens resultat uppgick till 17,5 MSEK (-93,7 M)Rörelseresultat uppgick till -203,1 MSEK (-286,7 M)Periodens resultat uppgick till -204,4 MSEK (-281,8 M)Resultat per aktie uppgick till 0,28 SEK (-1,50)Resultat per aktie uppgick till -3,28 SEK (-4,52)Resultat per aktie efter utspädning uppgick till 0,28 SEK (-1,50)Resultat per aktie efter utspädning uppg...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch