GlobeNewswire

COVIS PHARMA GROUP Announces Top-line Safety and Efficacy Data from a Phase 3 Placebo-Controlled COVID-19 Study Using Inhaled Corticosteroid (ciclesonide)

Share

ZUG, Switzerland, April 15, 2021 (GLOBE NEWSWIRE) -- Covis Pharma Group (the “Company”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, announced today top-line results from a 400 patient phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ciclesonide metered-dose inhaler in non-hospitalized patients 12 years of age and older with symptomatic COVID-19 infection.

The primary endpoint of the study was time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of ≥ 24 hours by Day 30. A sub-group analysis showed that time to alleviation of cough was the most improved symptom in the ciclesonide arm compared to the placebo arm by 6 days in 75% of the population.

A relevant secondary efficacy endpoint reaching statistical significance (p=0.0301) was the 70% reduction observed in the ciclesonide arm versus 30% in the placebo arm of patients with subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19 by Day 30. There were only a small number (n=10) of total events observed in this study. No new safety signals were identified with ciclesonide 320mcg twice daily for 30 days in the active comparator arm versus placebo. In addition, no new adverse events were reported after 60 days post treatment with ciclesonide.

The study randomized 400 patients in a 1:1 ratio to ciclesonide versus placebo. The study demonstrated a treatment difference between ciclesonide (70.6%) and placebo (63.5%) in the percentage of patients with an improved time to alleviation of COVID-19 related symptoms, which was not statistically significant, with a p-value of 0.5502.

“We are disappointed the results were not more positive, although there was a trend toward earlier cough cessation in the ciclesonide group. Further studies may want to look at whether this treatment may prevent or lessen post-acute COVID-19 syndrome,” said Michael Blaiss, MD, clinical professor at the Medical College of Georgia at Augusta University in Augusta, Georgia, a member of the steering committee for the trial.

About Alvesco
Alvesco (ciclesonide) Inhalation Aerosol is a glucocorticoid indicated for the long-term treatment of asthma as maintenance therapy in adults and adolescents 12 years of age and older in the U.S. and over 6 years of age in Canada. Alvesco Inhalation Aerosol is an inhaled glucocorticoid with a small particle size (1-2 μm) enabling it to reach areas of chronic inflammation in both the large and small airways. Alvesco is not indicated for the relief of acute bronchospasm. Alvesco is not indicated for children under 12 years of age in the U.S. or under the age of 6 in Canada.

Canada

Indication: ALVESCO is indicated for the prophylactic management of steroid-responsive bronchial asthma in adults, adolescents and children 6 years of age and older.
Contraindications:

  • ALVESCO (ciclesonide) is contraindicated in patients with known hypersensitivity to any of the ingredients. For a complete listing, see Dosage Forms, Composition and Packaging section of the PM.
  • ALVESCO is contraindicated in patients with untreated fungal, bacterial or tuberculosis infections of the respiratory tract.
  • ALVESCO is not to be used in the primary treatment of status asthmaticus or other acute episodes of asthma, or in patients with moderate to severe bronchiectasis.

United States of America

Indication: ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adults and adolescents 12 years of age and older.
Important Limitations of USE:

  • ALVESCO is NOT indicated for the relief of acute bronchospasm.
  • ALVESCO is NOT indicated for children under 12 years of age.

Important Safety Information for Alvesco (ciclesonide) Inhalation Aerosol

Contraindications

  • Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required.
  • Patients with a known hypersensitivity to ciclesonide or any of the ingredients of Alvesco.

Warnings & Precautions

  • Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse mouth following inhalation.
  • Potential worsening of existing tuberculosis: fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with above because of the potential for worsening of these infections.
  • Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Alvesco.
  • Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function with very high dosages or at the regular dosage in susceptible individuals. If such changes occur discontinue Alvesco slowly.
  • Suppression of growth in children. Monitor growth routinely in pediatric patients receiving Alvesco.
  • Development of glaucoma, increased intraocular pressure and posterior subcapsular cataracts. Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.

Please read Important Safety Information and Full Prescribing Information for the US and Canada PM.

About Covis
Covis, with global operations in Zug, Switzerland, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.

Trademarks are the property of their respective owners.

Media Contact
info@covispharma.com

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

REC Silicon - Minutes from Annual General Meeting 202111.5.2021 22:07:25 CEST | Press release

Oslo, Norway - May 11, 2021: The Annual General Meeting of the shareholders of REC Silicon ASA (REC Silicon) was held on May 11, 2021 at 4:00 pm CEST. The minutes from the Annual General Meeting recording the resolutions made are enclosed hereto and are also available on REC Silicon's website www.recsilicon.com. 134,647,476 shares were represented at the general meeting. Thus, approximately 36.16% of the Company's total share were represented at the Annual General Meeting. Further to the Notice of the Annual General Meeting issued on April 20, 2021, the Annual General Meeting approved, as follows from the minutes, all resolutions as proposed by the Board. For further information, please contact: James A. May II, Chief Financial Officer Phone: +1 509 989 1023 Email: james.may@recsilicon.com Nils O. Kjerstad, IR Contact Phone: +47 9135 6659 Email: nils.kjerstad@crux.no About REC Silicon REC Silicon is a leading producer of advanced silicon materials, delivering high-purity polysilicon an

Equinor ASA: Generalforsamlingen vedtok utbytte på USD 0,12 per aksje for fjerde kvartal 202011.5.2021 20:32:22 CEST | Pressemelding

Generalforsamlingen i Equinor ASA (OSE: EQNR, NYSE: EQNR) godkjente 11. mai 2021 styrets forslag til årsregnskap og årsberetning for Equinor ASA for 2020. Årsregnskap og årsberetning for Equinor ASA og for konsernet for 2020 ble godkjent, og det utdeles et utbytte på 0,12 amerikanske dollar per aksje for fjerde kvartal 2020. Utbyttet for fjerde kvartal 2020 tilfaller aksjeeiere som er registrert i Equinors aksjeeierregister i verdipapirsentralen (VPS) per utløpet av 14. mai 2021 (”Eierregisterdatoen”). Forutsatt ordinært oppgjør i VPS innebærer dette at man må være aksjeeier per 11. mai 2021 for å ha rett til utbytte. Utbytte til rettighetshavere under ADR-programmet (American Depository Receipts) i USA tilfaller også rettighetshavere per 11. mai 2021. Aksjene vil bli handlet eks. utbytte på Oslo Børs fra og med 12. mai 2021. På New York Stock Exchange vil ADR’er bli handlet eks. utbytte fra og med 13. mai 2021. Aksjeeiere med aksjer som handles på Oslo Børs vil motta sitt utbytte i no

Equinor ASA: Annual general meeting approved dividend of USD 0.12 per share for fourth quarter 202011.5.2021 20:32:22 CEST | Press release

On 11 May 2021, the annual general meeting (AGM) of shareholders in Equinor ASA (OSE: EQNR, NYSE: EQNR) approved the annual report and accounts for Equinor ASA for 2020, as proposed by the board of directors. The annual accounts and the annual report for Equinor ASA and the Equinor group for 2020 were approved, and a dividend of US dollar (”USD”) 0.12 per share will be distributed for the fourth quarter of 2020. The fourth quarter 2020 dividend accrues to the shareholders as registered in Equinor’s shareholder register with the Norwegian Central Securities Depository (VPS) as of expiry of 14 May 2021 (the ”Record Date”). Subject to ordinary settlement in VPS, this implies that the right to dividend accrues to shareholders as of 11 May 2021. For US ADR (American Depository Receipts) holders, dividend accrues also as of 11 May 2021. The shares will be traded ex-dividend on the Oslo Stock Exchange (Oslo Børs) from and including 12 May 2021. On New York Stock Exchange, the ADRs will trade

Kommuniké från årsstämma i Corline Biomedical AB (publ)11.5.2021 19:47:30 CEST | Pressemelding

Idag den 11 maj 2021 hölls årsstämma i Corline Biomedical AB (publ). Nedan följer en sammanfattning av de beslut som fattades. Samtliga beslut fattades enhälligt. Fastställande av resultat Bolagsstämman fastställde resultat- och balansräkningarna och beslutade, i enlighet med styrelsens förslag, att resultatet enligt den fastställda resultaträkningen skulle överföras i ny räkning. Någon utdelning lämnas inte. Ansvarsfrihet Bolagsstämman beviljade styrelseledamöterna och verkställande direktören ansvarsfrihet för förvaltningen av Bolagets angelägenheter under räkenskapsåret 2020. Något beslut fattades emellertid inte avseende styrelseordföranden, då han – som enda röstande på bolagsstämman – inte kunde rösta om den egna ansvarsfriheten. Fastställande av antalet styrelseledamöter, styrelsesuppleanter och antalet revisorer Stämman beslutade att styrelsen ska bestå av fem (5) styrelseledamöter samt en (1) styrelsesuppleant. Vidare beslutades att bolaget ska fortsätta ha ett registrerat rev

TGS-NOPEC Geophysical Company ASA (TGS) - Annual General Meeting Held11.5.2021 18:44:31 CEST | Press release

OSLO, Norway (11 May 2021) - The Annual General Meeting of TGS was held on 11 May 2021. All resolutions proposed were approved by the shareholders. The minutes from the Annual General Meeting are attached to this announcement. About TGS TGS provides scientific data and intelligence to companies active in the energy sector. In addition to a global, extensive and diverse energy data library, TGS offers specialized services such as advanced processing and analytics alongside cloud-based data applications and solutions. Forward Looking Statement All statements in this press release other than statements of historical fact are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. These factors include TGS' reliance on a cyclical industry and principal customers, TGS' ability to continue to expand markets for licensing of data, and TGS' ab

Banque Profil de Gestion SA : Changement d’actionnaire de référence, nouvelle raison sociale et changements au sein du Conseil d’administration11.5.2021 18:21:13 CEST | Press release

Communiqué de presse Banque Profil de Gestion SA : Changement d’actionnaire de référence, nouvelle raison sociale et changements au sein du Conseil d’administration Genève, le 11 mai 2021 – Comme annoncé le 9 février dernier, Banque Profil de Gestion SA (BPDG), son actionnaire actuel de référence (Banca Profilo S.p.A) ainsi que les actionnaires de la société One Swiss Bank SA (OSB) ont signé deux contrats de vente d’actions formalisant, d’une part, le rachat par BPDG de 100% du capital de OSB et, d’autre part, la cession par Banca Profilo SpA des 60.4% d’actions qu’elle détient dans BPDG aux actionnaires actuels de OSB (la «Transaction»). La Transaction impliquera également la fusion subséquente par absorption de OSB par BPDG. Pour rappel, la Transaction est notamment soumise à agrément de la FINMA. Les démarches y relatives sont en cours et l’exécution des deux contrats de vente formalisant la Transaction (le «Closing ») interviendra le 1er juin prochain, sauf objection de la FINMA d’

Brunel AGM 202111.5.2021 18:00:00 CEST | Press release

Amsterdam, 11 May 2021 – Brunel International N.V. (Brunel; BRNL), a global provider of flexible workforce solutions and expertise, today announced the voting results of the Annual General Meeting of Shareholders (AGM) of 11 May 2021. The AGM approved all voting items that were on the agenda. As a result, Jilko Andringa is reappointed as a member of the board of directors for a new term of four years. At the close of the meeting Mr Aat Schouwenaar, chairman of the supervisory board, retired from the supervisory board after having served on the supervisory board for 20 years. Mr Just Spee is reappointed as a member of the Supervisory Board for his second term of four years and will succeed Mr Aat Schouwenaar as chair of the Supervisory Board. Mr Frank van der Vloed is appointed as member of the Supervisory Board for a term of four years. A dividend of €0.30 per share of €0.03 par value has been declared for the 2020 financial year. The dividend, less 15% dividend withholding tax, will b