Human Trials

Hope Biosciences gets FDA nod for phase 2 COVID-19 stem cell therapy trial

Hope Biosciences has been given clearance from the US Food and Drug Administration (FDA) to move ahead with a phase 2 trial to evaluate its investigational stem cell therapy in providing immune support against COVID-19.

Ridgeback Biotherapeutics announces MHRA clearance to begin human testing of EIDD-2801 in UK for COVID-19

Ridgeback Biotherapeutics announced clearance by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an orally available antiviral compound, EIDD-2801, to begin human testing.  This action by the MHRA allowed Ridgeback to commence Phase 1 in the UK. 

Lilly launches clinical testing of baricitinib and LY3127804 in COVID-19

Eli Lilly and Company (Lilly) has started clinical testing of its oral JAK1/JAK2 inhibitor OLUMIANT (baricitinib) and investigational candidate LY3127804 in separate COVID-19 trials.

Arrowhead Pharmaceuticals files for regulatory clearance to begin phase 1/2a study of ARO-ENaC for treatment of cystic fibrosis

Arrowhead Pharmaceuticals has filed an application for clearance to begin a Phase 1/2a clinical trial of ARO-ENaC, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with cystic fibrosis (CF), which is a rare disease caused by genetic mutations that lead to progressive deterioration in lung function due to poor clearance of mucus and associated recurrent infections.

OncoImmune receives FDA approval for COVID-19 clinical trial

OncoImmune has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID).

CROMSOURCE announces launch of COVID-19 clinical trial

CROMSOURCE, an international contract research organization (CRO) with its global headquarters in Verona, Italy, has announced that it has initiated its first COVID-19 trial on behalf of a European pharmaceutical company.

Montreal Heart Institute, NYU Grossman School of Medicine collaborate on COVID-19 clinical trial

The Montreal Heart Institute (MHI) Research Centre has collaborated with New York City’s NYU Grossman School of Medicine for a new COVID-19 clinical study.

GSK’s asthma drug Nucala meets co-primary endpoints in SYNAPSE trial

GlaxoSmithKline (GSK) said that its asthma drug Nucala (mepolizumab) has succeeded in the phase 3 SYNAPSE trial in patients with nasal polyps associated with chronic rhinosinusitis (CRSwNP).

BeiGene doses first patient in phase 1b/2 trial of ZW25 in HER2-positive breast cancer and GEA

Zymeworks announced that its partner, BeiGene has dosed the first patient in a two-arm Phase 1b/2 trial evaluating the former's HER2-targeted bispecific antibody ZW25 in combination with chemotherapy as a first-line treatment for patients with metastatic HER2-positive breast cancer and in combination with chemotherapy and BeiGene’s PD-1-targeted antibody tislelizumab as a first-line treatment for patients with metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).