Clinical trial

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 RESP-X at 1mg/kg. No serious adverse events were reported, […]

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, and positive early-stage results have been reported from ongoing […]

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 higher levels of dosing. Avacta’s Safety Data Monitoring Committee […]

Sequana Medical, a company treating fluid overload in liver disease, heart failure and cancer, has announced positive results from its Phase I single-centre, single-arm, single-dose trial (CHIHUAHUA) with its second-generation DSR product (DSR 2.0).   The purpose of the trial was to evaluate the safety and tolerability profile of DSR 2.0, as well as to understand […]

A Phase II trial to investigate onvansertib for the second line treatment of patients with KRAS/NRAS-mutated metastatic colorectal cancer (mCRC) has treated its first patients. The ONSEMBLE trial is designed to demonstrate a clinically meaningful difference in response and onvansertib’s contribution to standard of care (SoC) FOLFIRI/bevacizumab. “We are excited to be underway with our […]

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 expected to enrol 10 patients, aged 18-75 years, who have had […]

The primary endpoint has been achieved in a Phase II trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of atrial fibrillation (AF) to normal sinus rhythm. Acesion Pharma enrolled 63 patients with a current episode of AF in the trial and tested two intravenous doses of AP30663, 3 and 5mg/kg, compared to […]

The US Food and Drug Administration (FDA) has cleared Intellia Therapeutics’ Investigational New Drug (IND) application for NTLA-2002 for the treatment of hereditary angioedema (HAE).  Intellia is a clinical-stage genome editing company focused on developing potentially curative therapies using CRISPR-based technologies.   The decision will enable the company to include the United States in the global […]

Atom Bioscience has revealed positive results from its China Phase IIa clinical trial of ABP-671, its URAT1 inhibitor for chronic gout.  The randomised, double-blind, placebo-controlled trial enrolled 54 patients with gout or  across six cohorts, with seven randomised to ABP-671 and two to placebo per cohort.  “The results from our Phase IIa clinical trial in […]

The new Liverpool Clinical Research Facility (CRF) unit has opened at the new Royal Liverpool University Hospital thanks to £5.3m ($6.4m) funding from the National Institute for Health Research (NIHR).   The CRF will explore new treatments and vaccines for a range of diseases prevalent in Liverpool’s communities. This includes research into cancer and heart […]

Newron Pharmaceuticals’ Evenamide could be a potential breakthrough treatment in the management of treatment-resistant schizophrenia (TRS) patients, according to new trial data.  The drug is being assessed as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS who are not responding to their current antipsychotic medication.  The efficacy results, based […]

Minoryx Therapeutics has revealed the findings from the first and largest international study to enroll adult male X-linked adrenoleukodystrophy patients.  The Phase II/III ADVANCE clinical trial of lead candidate, leriglitazone, published in The Lancet Neurology, did not meet the primary outcome for the six-minute walk test.   However, clinical measures of body sway (assessing balance) demonstrated […]

Swedish start-up Atrogi has enrolled the first patient in its Phase Ia/b study of ATR-258, a novel b2adrenoceptor agonist for the treatment of type 2 diabetes and comorbidities.  Conducted in Mannheim, Germany by Clinical Research Services (CRS), the trial is expected to be completed by April 2023 with the final report in June 2023.   The […]

Genoscience Pharma, a clinical-stage biotech company developing lysosomotropic drug candidates for the treatment of cancer, fibrosis and auto-immune diseases through autophagy modulation has launched the ABE-LIVER study, along with trial sponsor Grenoble University Hospital.  The trial   This Phase IIb clinical trial will focus on first-line treatment of HepatoCellular Carcinoma (HCC) patients with Genoscience Pharma’s drug […]

In January 2022, DDW’s Megan Thomas spoke to decision-makers from the drug discovery industry about their predictions on what 2022 holds for our sector. As we head into 2023, DDW will be publishing a series of reflections on these predictions. Here, Thomas reflects specifically on Anita Cooper’s prediction relating to the importance of clinical trials.  […]

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for VAX-24, Vaxcyte’s 24-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease.  The decision was based on positive topline results from a Phase I/II proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age.  […]