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DGAP-News: Positive Results from Adrenomed's AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM

Wednesday, September 16, 2020 - 7:00am

[1]

Key Points: 
  • [1]
    The AdrenOSS-2 Phase II trial ( NCT03085758 [2] ) achieved its primary endpoint: No differences in serious or possibly related Treatment Emergent Adverse Events (TEAEs) between Adrecizumab and placebo were observed.
  • As already demonstrated in previous Phase I trials, Adrecizumab exhibited a favorable safety and tolerability profile in septic shock patients.
  • [3]
    28-day all-cause mortality analysis including all patients (n=301) showed a trend towards a survival benefit for Adrecizumab treated patients.
  • Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock.

Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis

Sunday, August 2, 2020 - 8:00pm

"Patients in the EMPhASIS trial exhibitedrobust responses across all study endpoints included in the top-line analysis.

Key Points: 
  • "Patients in the EMPhASIS trial exhibitedrobust responses across all study endpoints included in the top-line analysis.
  • The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS.
  • June 2020: Dosed the first patients in CALVID-1 clinical trial, a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 trial of IMU-838 in patients with moderate COVID-19.
  • IMU-838 is in phase 2 clinical development for COVID-19, relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial considered in Crohn's disease.

DGAP-News: Immunic, Inc. Reports Positive Top-line Data from Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis

Sunday, August 2, 2020 - 9:00pm

"Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis.

Key Points: 
  • "Patients in the EMPhASIS trial exhibited robust responses across all study endpoints included in the top-line analysis.
  • The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of IMU-838 in patients with RRMS.
  • All enrolled patients were required to have shown disease activity based on clinical evidence of relapse and additional MRI criteria.
  • - June 2020: Dosed the first patients in CALVID-1 clinical trial, a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 trial of IMU-838 in patients with moderate COVID-19.

RedHill Biopharma Initiates Global Phase 2/3 Study for COVID-19

Thursday, July 30, 2020 - 12:00pm

We quickly launched a Phase 2 study in the U.S. and are now expanding the program globally with a Phase 2/3 study to allow us to collect a broad and rigorous data set in a short amount of time.

Key Points: 
  • We quickly launched a Phase 2 study in the U.S. and are now expanding the program globally with a Phase 2/3 study to allow us to collect a broad and rigorous data set in a short amount of time.
  • The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study ( NCT04467840 ) is set to enroll up to 270 patients in up to 40 clinical sites across European, Latin American and other countries.
  • The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14.
  • Enrollment is also ongoing for a randomized, double-blind, placebo-controlled Phase 2 clinical study with opaganib in the U.S. ( NCT04414618 ).

DGAP-News: Immunic, Inc. Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19

Monday, June 15, 2020 - 12:03pm

Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19

Key Points: 
  • Announces First Patients Dosed in its Phase 2, CALVID-1 Clinical Trial of IMU-838 in COVID-19
    The issuer is solely responsible for the content of this announcement.
  • Patients will be enrolled at 10 to 35 centers in Germany, the United States and a half dozen European countries.
  • It is a prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial in patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838.
  • IMU-838 is in phase 2 clinical development for COVID-19, relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial considered in Crohn's disease.

Inventiva to provide an update on the NATIVE Phase IIb clinical trial in NASH during a Key Opinion Leader webcast

Tuesday, April 21, 2020 - 4:45pm

Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of NASH, a common and progressive chronic liver disease, for which there is currently no approved therapy.

Key Points: 
  • Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of NASH, a common and progressive chronic liver disease, for which there is currently no approved therapy.
  • The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH.
  • Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies.
  • Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (Euronext: IVA ISIN: FR0013233012).

FDA Authorizes Athersys to Initiate a Pivotal Clinical Trial Evaluating MultiStem® Cell Therapy in Patients With COVID-19 Induced Acute Respiratory Distress Syndrome

Monday, April 13, 2020 - 11:00am

The Company plans to open the first clinical sites for recruitment of this MACOVIA (MultiStem Administration for COVID-19 Induced ARDS) study this quarter.

Key Points: 
  • The Company plans to open the first clinical sites for recruitment of this MACOVIA (MultiStem Administration for COVID-19 Induced ARDS) study this quarter.
  • This trial will be a multicenter study featuring an open-label lead-in followed by a double-blinded, randomized, placebo-controlled Phase 2/3 portion.
  • The second cohort will be a double-blind, randomized, placebo-controlled run-in phase to evaluate the efficacy of MultiStem.
  • Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.

Inventiva announces completion of patient visits for its Phase IIb clinical study with lanifibranor in NASH

Tuesday, March 17, 2020 - 4:45pm

The NATIVE (NAsh Trial to Validate IVA337 Efficacy) trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical study evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (NASH).

Key Points: 
  • The NATIVE (NAsh Trial to Validate IVA337 Efficacy) trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical study evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (NASH).
  • Throughout the study, the safety profile of lanifibranor has been regularly assessed by an external, independent Data Safety Monitoring Board (DSMB).
  • The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (NASH).
  • Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies.

Fulcrum Therapeutics Announces Completion of Enrollment in Phase 2b Trial of Losmapimod for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)

Wednesday, February 26, 2020 - 12:00pm

We remain on track to report topline data on the primary endpoint in the third quarter of this year.

Key Points: 
  • We remain on track to report topline data on the primary endpoint in the third quarter of this year.
  • ReDUX4 is an international, multicenter, randomized, Phase 2b double-blind, placebo-controlled, 24-week trial of losmapimod in approximately 80 patients with genetically confirmed FSHD.
  • The open label extension allows patients randomized to losmapimod to continue treatment and for patients randomized to placebo to initiate treatment with losmapimod.
  • Fulcrum is currently conducting Phase 2 trials investigating the safety, tolerability, and efficacy of losmapimod to treat the root cause of FSHD.

Ra Pharmaceuticals Announces Dosing of First Patient in Phase 2 Clinical Trial of Zilucoplan for IMNM

Wednesday, December 4, 2019 - 12:00pm

The randomized, double-blind, placebo-controlled, multi-center, Phase 2 clinical trial will evaluate the safety, tolerability, and efficacy of zilucoplan in patients with IMNM who are positive for anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) or anti-signal recognition particle (SRP) autoantibodies.

Key Points: 
  • The randomized, double-blind, placebo-controlled, multi-center, Phase 2 clinical trial will evaluate the safety, tolerability, and efficacy of zilucoplan in patients with IMNM who are positive for anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) or anti-signal recognition particle (SRP) autoantibodies.
  • Patients will be randomized in a 1:1 ratio to receive daily subcutaneous (SC) doses of 0.3 mg/kg zilucoplan or placebo.
  • Following completion of the trial, patients will have the option to enter into an open-label long-term extension study with zilucoplan.
  • With both the Phase 2 clinical trial in IMNM and the Phase 3 clinical trial in gMG now underway, weve taken important steps in our efforts to bring innovative and accessible therapies to patients with rare, complement-mediated diseases.