Human Trials

Celltrion receives Korean MFDS approval to initiate trial of Covid-19 antiviral antibody treatment candidate

Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate.

FARXIGA significantly reduces kidney failure and CV or renal death risks in CKD patients in DAPA-CKD trial

Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s FARXIGA (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion.

FSD Pharma seeks FDA nod for FSD201 phase 2 trial in Covid-19 patients

FSD Pharma has filed an application with the US Food and Drug Administration (FDA) seeking its approval to launch a phase 2 trial for FSD201 (ultramicronised palmitoylethanolamide, or ultramicronised PEA) in Covid-19 patients.

Treadwell initiates expansion of cohorts in phase 1 study of CFI-402257

Treadwell Therapeutics announced the initiation of three expansion cohorts in its ongoing Phase 1 study evaluating CFI-402257, a selective and highly potent oral inhibitor of tyrosine threonine kinase (TTK).

Novartis’ ABL001 meets primary endpoint of phase 3 chronic myeloid leukemia study

Novartis announced that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib.

AstraZeneca begins phase 1 trial of Covid-19 dual-use candidate AZD7442

AstraZeneca has initiated a phase 1 trial of a monoclonal antibody combination called AZD7442, which is being developed for the prevention and treatment of Covid-19.

Odonate announces positive top-line results for Tesetaxel in phase 3 metastatic breast cancer trial

Odonate Therapeutics announced positive top-line results from CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC).

Novartis’ phase 3 COMBI-i trial fails to meet primary endpoint

Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival.

SAB Biotherapeutics launches SAB-185 phase 1b trial in Covid patients

SAB Biotherapeutics said that it has dosed the first patient in the phase 1b trial of SAB-185 for evaluating its safety and pharmacological activity as a potential treatment for Covid-19.