FSD Pharma has dosed the first cohort of patients in its Phase I clinical trial evaluating Lucid-MS for the treatment of multiple sclerosis (MS). “Our clinical development team and international advisory committee are delighted at the progress of this milestone and completing dosing the first cohort,”… Read More
Bloom Science has completed enrolment of healthy adult participants as part of its Phase I clinical trial into BL-001 for Dravet syndrome, a rare paediatric epilepsy. BL-001 is an orally administered Live Biotherapeutic Product reverse translated from the positive clinical outcomes associated with the Ketogenic Diet… Read More
Danish biotech MinervaX has launched the first Phase I clinical study in older adults of its novel Group B Streptococcus (GBS) vaccine, at CEVAC (Centre for Vaccinology) in Ghent, Belgium. GBS is a global unmet medical burden and can cause serious illness in people of all… Read More
A combination of the PARP inhibitor olaparib (Lynparza) and the investigational ATR inhibitor ceralasertib showed clinical benefit in paediatric patients with solid tumours exhibiting DNA replication stress and/or DNA repair deficiencies, according to new data. The results from the Phase I portion of the Phase I/II… Read More
Totus Medicines has dosed its first patient in a Phase I clinical trial of TOS-358, a first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations. The Totus Accel Platform is designed to be the first biosearch technology that scans, maps, and… Read More
Evecxia Therapeutics has reported favourable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial of EVX-101 in healthy volunteers treated with escitalopram. The company is also planning a Phase II adjunctive EVX-101 trial in patients with major depressive disorder (MDD) responding inadequately to a… Read More
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The headlines this week have revealed a high level of clinical trial activity taking place… Read More
Endogena Therapeutics has completed the dose-escalation stage of its Phase I/IIa study of EA-2353 in retinitis pigmentosa (RP) with no clinically relevant or dose-limiting adverse events. Given the positive safety and tolerability profile, the study will now enrol patients into the expansion cohort, using the highest… Read More
RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial. The first cohort consisted of eight healthy volunteers who received doses of… Read More
News round-up for 3-7 April by DDW Digital Content Editor Diana Spencer. The headlines this week have revealed a high level of clinical trial activity taking place internationally. In just the last few days, new clinical trials in colorectal cancer, osteoarthritis, and brain cancer have been launched,… Read More
Sequana Medical has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. Fluid accumulation in heart failure patients is caused by the retention of too much… Read More
Avacta Group has dosed its first patient in the fifth cohort of the first-in-human Phase I trial (ALS-6000-101) of AVA6000 in solid tumours. This follows the approval of an amended clinical trial protocol by the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) to allow for… Read More
A Phase I clinical trial has begun evaluating Direct Biologics’ ExoFlo for the treatment of patients with medically refractory ulcerative colitis (UC). Direct Biologics uses extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs) to address multiple disease indications. The trial is… Read More
The first subjects have been dosed in a Phase I clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor in heart disease. The drug works by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9). “We’re… Read More
Purple Biotech has revealed positive new results from exploratory analyses conducted as part of a Phase I dose escalation study into CM24 plus nivolumab for advanced cancer. The study enrolled 14 patients with advanced cancers including 11 patients with pancreatic adenocarcinoma (PDAC), two patients with colorectal… Read More
Dosing has begun in a Phase I clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with… Read More
