AB201 / Oruka Therapeutics - LARVOL DELTA

Novel Tissue Factor Inhibition for Thromboprophylaxis in COVID-19: Primary Results of the ASPEN-COVID-19 Trial. (PubMed, Arterioscler Thromb Vasc Biol) - P2/3 | "rNAPc2 treatment in hospitalized patients with COVID-19 was well tolerated without excess bleeding or serious adverse events but did not significantly reduce D-dimer more than heparin at day 8."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Inflammation • Novel Coronavirus Disease • Thrombosis

ASPEN: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (clinicaltrials.gov) - P2/3 | N=160 | Completed | Sponsor: ARCA Biopharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

Rationale and design of a study to assess the safety and efficacy of rNAPc2 in COVID-19: the Phase 2b ASPEN-COVID-19 trial. (PubMed, Am Heart J) - P2/3 | "ASPEN-COVID-19 will provide important data on a novel therapeutic approach that may improve outcomes in hospitalized COVID-19 patients beyond available anticoagulants by targeting tissue factor, with potential effects on not only thrombosis but also inflammation and viral propagation."

Clinical • Journal • P2b data • Cardiovascular • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • Thrombosis

ASPEN: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (clinicaltrials.gov) - P2/3; N=160; Active, not recruiting; Sponsor: ARCA Biopharma, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

ARCA biopharma Announces Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Phase 2b topline data anticipated in first quarter of 2022."

P2b data • Infectious Disease • Novel Coronavirus Disease

ASPEN: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (clinicaltrials.gov) - P2/3; N=160; Recruiting; Sponsor: ARCA Biopharma, Inc.; N=100 ➔ 160; Trial completion date: May 2021 ➔ Dec 2021; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

ARCA biopharma Provides Update on ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 as a Potential Treatment for COVID-19 (GlobeNewswire) - "ARCA has received approval from regulatory authorities in Argentina and Brazil to enroll patients in ASPEN-COVID-19. The trial is currently enrolling patients at seven investigative sites in the United States. The Company anticipates enrolling the first South American patients in July 2021. Trial target enrollment is being increased from 100 to 160 patients in order to maximize the sample size....To date, 77 patients have been enrolled in the trial. The Company also updated its guidance and now anticipates topline data from this international Phase 2b clinical trial in the fourth quarter of 2021."

Enrollment status • P2b data • Trial status • Infectious Disease • Novel Coronavirus Disease

ARCA biopharma Announces rNAPc2 COVID-19 Patent Assignment Agreement (GlobeNewswire) - "ARCA biopharma, Inc....entered into a patent assignment agreement with the University Medical Center of Johannes Gutenberg University Mainz, Germany. Under the agreement, ARCA receives exclusive world-wide patent rights to the use of rNAPc2 as a potential treatment for COVID-19, and other indications...ARCA also obtains an option to acquire world-wide patent rights to discoveries related to the use of rNAPc2 as a potential therapeutic for auto-immune disorders such as systemic lupus erythematosus...ARCA has potential upfront and milestone obligations that could total approximately €1.6 million and royalty obligations in the low single digit range, if rNAPc2 receives regulatory approval and is commercialized."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

ARCA biopharma Announces 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "'We are currently actively enrolling patients in a Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 who are at high risk for thrombotic complications,'...Phase 2b topline data anticipated in the third quarter of 2021."

Enrollment status • P2b data • Infectious Disease • Novel Coronavirus Disease

ASPEN: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (clinicaltrials.gov) - P2/3; N=100; Recruiting; Sponsor: ARCA Biopharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • CRP • IL6

ARCA biopharma Announces First Patients Enrolled in ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID-19 (GlobeNewswire) - "ARCA biopharma, Inc....today announced that the first patients have been enrolled in ASPEN-COVID-19...The first patient was enrolled at the University of Colorado Hospital on December 10, 2020, with a total of 5 patients randomized to date. The Company currently anticipates topline trial data from this Phase 2b clinical trial in the second quarter of 2021."

P2b data • Trial status • Novel Coronavirus Disease

ASPEN: Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (clinicaltrials.gov) - P2/3; N=100; Not yet recruiting; Sponsor: ARCA Biopharma, Inc.

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

AB201 Development as a Potential Treatment for COVID-19 Receives U.S. FDA Fast Track Designation (GlobeNewswire) - "ARCA biopharma, Inc....today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19."

Fast track designation • Infectious Disease • Novel Coronavirus Disease

ARCA biopharma Announces FDA Approval of IND Application for AB201 as a Potential Treatment for COVID-19 (GlobeNewswire) - "Initiation of Phase 2b clinical trial anticipated in Q4 2020; Trial to enroll approximately 100 patients hospitalized with COVID-19; Topline data anticipated Q2 2021; ARCA biopharma, Inc....today announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for AB201....ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19....Phase 3 will be event driven, with an estimated requirement of 450 patients. The Phase 2b and Phase 3 trials are described in a common protocol and use identical entry criteria and the same heparin regimen control."

IND • New P2b trial • New P3 trial • P2 data • Infectious Disease • Novel Coronavirus Disease

ARCA biopharma Announces Submission of IND Application to U.S. FDA for AB201 as a Potential Treatment for COVID-19 (GlobeNewswire) - "ARCA biopharma, Inc....today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) under the Coronavirus Treatment Acceleration Program (CTAP) to evaluate AB201 for the treatment of patients hospitalized with COVID-19. Pending FDA feedback, ARCA anticipates initiating the Phase 2b portion of a sequential Phase 2b/3 clinical evaluation of AB201 as early as the fourth quarter of this year."

IND • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease