SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Blade Therapeutics today announced that it has reached the 120-subject enrollment goal for the Phase 2 clinical study of the Company’s investigational therapeutic, BLD-2660, in the treatment of coronavirus disease-2019 (COVID-19) pneumonia. Also, an independent Data Monitoring Committee (DMC) recommended continuation of the trial without changes after conducting a planned review of blinded safety data. BLADE-CONQUER is a double-blind, placebo-controlled clinical trial assessing the efficacy and safety of BLD-2660 on lung function and recovery time in hospitalized patients (N=120) with pneumonia due to SARS-CoV-2 infection. In the study, which started enrollment in May 2020, patients receive up to 10 days of therapy with BLD-2660 or matching placebo dosed orally twice daily on top of standard-of-care therapeutics, including Remdesivir.
“Current therapies do not sufficiently address the overactive inflammatory responses to SARS-CoV-2 infection that play a significant role in COVID-19 lung damage,” said Wendye Robbins, M.D., President and Chief Executive Officer of Blade Therapeutics. “Reaching the 120-subject enrollment goal for this important study of BLD-2660 and the DMC recommendation to continue as planned are encouraging developments.”
CONQUER (COVID Study of New Drug BLD-2660 in Subjects ReQUiring Hospitalization to Evaluate Safety and Response, Clinicaltrials.gov NCT04334460) is a 28-day clinical trial with a 60-day post-study lung function assessment. The study will measure two primary and multiple secondary outcomes in hospitalized patients with pneumonia (oxygen saturation <94% and not yet mechanically ventilated) due to SARS-CoV-2 infection. The first primary outcome is time to recovery as defined by no longer requiring oxygen support or meeting discharge from hospital readiness criteria, whichever occurs first. The second primary outcome is change in oxygenation measured by change in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2) from baseline to Day 10 or hospital discharge, if sooner. Secondary measures include evaluation of safety and tolerability, functional improvements, and biomarkers.
“Blade is grateful for the commitment of the trial sites and investigators for making continued progress with this important Phase 2 trial in the challenging environment of an ongoing pandemic,” said Gary Patou, M.D., Chief Medical Officer of Blade Therapeutics. “We look forward to topline results in 4Q-2020.”
The oral calpain inhibitor BLD-2660 is a direct anti-fibrotic agent with multiple opportunities in idiopathic pulmonary fibrosis (IPF), scleroderma interstitial lung disease (ILD) and COVID-19. This investigational therapy has received orphan drug designation from the FDA for treatment of IPF. BLD-2660 inhibits dimeric calpain overactivity and broadly targets the IL-6 family of cytokines. As a result, BLD-2660 has the potential to stop – or even reverse – the overactivation of the immune system and progression of fibrosis in several organs, including the lungs and liver. BLD-2660 also downregulates calprotectin, a protein complex and neutrophil activation marker that tracks with lung dysfunction. In COVID-19 disease, BLD-2660 offers a novel approach to quell runaway cytokine activity and tissue damage response as a result of SARS-CoV-2 infection.
Blade Therapeutics is a private biopharmaceutical company that is advancing a robust pipeline of potential first- and best-in-class investigational therapies for diseases of lung, liver and heart fibrosis, as well as neuro-degenerative diseases and COVID-19. Blade’s core science centers on developing selective small-molecule inhibitors of dimeric calpains (calpains 1, 2 and 9) that underly fibrotic processes. Dimeric calpain over-activation promotes signaling processes foundational to cell/tissue damage response leading to fibrosis, neuro-degenerative diseases, and disease sequelae seen in COVID-19. The Blade pipeline includes several small-molecule direct inhibitors of dimeric calpains, including its lead clinical-stage asset BLD-2660, augmented by an autotaxin inhibitor (BLD-0409) that offers a distinct but complementary anti-fibrotic mechanism. Blade currently has multiple clinical programs underway, including study of BLD-2660 in the treatment of IPF, ILD and COVID-19.
Since its founding in 2015, the Company has raised approximately $90 million, including investments from Deerfield Management, MPM Capital, Pfizer Ventures, One Ventures, Osage University Partners and pharma strategic investments from Bristol-Myers Squibb and Novartis Institutes for Biomedical Research. The Company has assembled critical leadership expertise supplemented by a world-class network of scientific, pharmaceutical and clinical advisors to enable efficient and successful drug development. Visit www.blademed.com for more information.
COVID-19 disease has quickly become a global pandemic with more than 27 million confirmed cases, nearly 900,000 deaths and very few treatments identified. It is estimated that approximately one in five symptomatic COVID-19 cases are severe-critical, and pneumonia is reported as a complication in 75% of hospitalized patients. New treatments are needed to prevent or slow SARS-CoV-2 viral infection which causes COVID-19 disease, lessen severity of sequelae and accelerate recovery.
Fibrosis is a complex, pathologic process characterized by the thickening or scarring of organ tissue in response to cell/tissue damage or inflammation caused by infection, altered metabolism, diseases or toxins. Ongoing dysregulation of key biological pathways underlies the progression of organ fibrosis. As a result of fibrotic scarring, tissue no longer functions normally, leading to worsening disability and death. Diseases characterized by uncontrolled, progressive fibrosis include IPF, non-alcoholic steatohepatitis (NASH) and systemic sclerosis (SSc). New safe, well-tolerated therapies that provide robust attenuation of disease progression are urgently needed to address the high burden of fibrotic diseases.