Human Trials

TFF Pharmaceuticals, Felix Biotechnology sign LOI for collaboration, development and licence agreement

TFF Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, and Felix Biotechnology, a clinical stage, biotherapeutic-based antibiotic development company, today jointly announce that both companies have entered into a letter of intent (LOI) which reflects the parties’ non-binding agreement in principle to negotiate and enter into a collaboration, development and licence agreement (CDLA).

GW Pharmaceuticals initiates phase 3 study of Nabiximols for multiple sclerosis-associated spasticity

GW Pharmaceuticals along with U.S. subsidiary Greenwich Biosciences, today announced that the Company has initiated the first U.S. Phase 3 clinical trial studying nabiximols for multiple sclerosis (MS)-associated spasticity.

Ionis and Akcea announce that Pfizer initiated clinical study of vupanorsen

Ionis Pharmaceuticals and its wholly owned subsidiary Akcea Therapeutics, Inc., today announced that Pfizer has initiated a Phase 2b study of vupanorsen (AKCEA-ANGPTL3-LRx) in statin-treated patients with elevated non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TGs). The study, Targeting ANGPTL3 with an antisense oligonucleotide in adults with dyslipidemia (TRANSLATE-TIMI 70), will evaluate various doses of vupanorsen to inform potential future development.

Bristol Myers Squibb’s deucravacitinib meets co-primary endpoints in psoriasis study

Bristol Myers Squibb (BMS) announced that its deucravacitinib (BMS-986165) has achieved both co-primary endpoints in the phase 3 psoriasis study.

Neuraly gets FDA clearance of INDA to initiate phase 2b trial of NLY01 in Alzheimer’s Disease

Neuraly announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease.

Humanigen announces first patient dosed in NIH ACTIV-5/Big Effect trial evaluating lenzilumab for Covid-19

Humanigen, a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced that the first patient has been dosed at the Emory University School of Medicine in Atlanta, Georgia as part of the in the ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in patients hospitalized with COVID-19.

Aurinia begins voclosporin trial in kidney transplant recipients with Covid-19

Aurinia Pharmaceuticals has announced the commencement of an open-label exploratory trial to assess antiviral activity of voclosporin in kidney transplant recipients (KTRs) with Covid-19.

ANA Therapeutics starts oral niclosamide trial for Covid-19 treatment

Silicon Valley-based biotech start-up ANA Therapeutics has commenced a phase 2/3 clinical trial of oral niclosamide (ANA001) to treat the Covid-19 disease.

HiFiBiO completes first cohort of phase 1 study of SARS-CoV-2 neutralising antibody

HiFiBiO Therapeutics, a multinational biotherapeutics company with unique expertise in immune modulation and single-cell science, announced the successful completion of the first cohort of the Phase I study (NCT04590430) of HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment and prevention of COVID-19.