February's top stories: 60% of trial results not shared, Dilaforette-AGU team-up
Yale School of Medicine researchers revealed about 60% of academic clinical trial results were not shared after completion, and Dilaforette and Arabian Gulf University were to collaborate on a Phase II proof-of-concept trial of sevuparin in patients with sickle cell disease. Drugdevelopment-technology.com wraps-up the key headlines from February.
A new study conducted by Yale School of Medicine researchers revealed that about 60% of academic clinical trial results were not being shared after completion.
According to the study report, which was published in the British Medical Journal, less than 40% of results for clinical trials conducted at leading academic medical centres were shared within two years of completion.
The research team reviewed more than 4,300 clinical trials, and analysed how many were published or had results reported on ClinicalTrials.gov within 24 months of the studies' completion.
Swedish biotech firm Dilaforette and Bahrain-based Arabian Gulf University (AGU) were set to collaborate on a Phase II proof-of-concept trial of sevuparin in patients with sickle cell disease (SCD) experiencing acute vaso-occlusive crisis (VOC).
Sevuparin is a polysaccharide drug candidate developed to treat VOC in SCD patients by normalising reduced blood flow.
Dilaforette is a Karolinska Development portfolio company focused on new treatments for patients with SCD.
The collaboration will facilitate the development of Dilaforette's lead candidate, sevuparin, for SCD patients.
Under the deal, AGU will provide up to $1.2m in non-dilutive funding for the trial and assist with patient recruitment.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) approved a Phase I clinical trial of JHL1101, a potential treatment for rheumatoid arthritis (RA).
JHL1101 is a rituximab biosimilar, which was developed and manufactured by a Taiwanese subsidiary of JHL Biotech.
The company was the first biotech firm from the Greater China region to receive European approval for a clinical trial of a monoclonal antibody biosimilar.
Around 150 patients with severe RA will be enrolled in the trial, which is designed to compare JHL1101 with its reference product, Roche's MabThera.
The company seeks to show pharmacokinetic (PK) and pharmacodynamic (PD) similarity to Mather as well as the safety and efficacy of JH1101.
UK-based Atlantic Healthcare started enrolling patients in a Phase III trial of alicaforsen enema to treat pouchitis, an inflammatory bowel disease (IBD).
The Phase III trial will be the largest ever conducted for pouchitis, for which there are currently no approved treatments.
A total of 138 patients were enrolled at 40 clinical trial centres across the US, Canada, Europe and Israel, with results expected in the second half of next year. The trial was designed to evaluate the safety and efficacy of alicaforsen enema in patients with active, chronic, antibiotic refractory pouchitis.
US-based Allena Pharmaceuticals started its 28-day Phase II trial of ALLN-177, an orally administered recombinant oxalate-degrading enzyme, and potential treatment for hyperoxaluria and kidney stones.
Hyperoxaluria results from high oxalate levels in urine, due to a genetic defect causing hyper-absorption or overproduction of oxalate by the liver.
The Phase II trial was designed to evaluate ALLN-177 in reducing urinary oxalate excretion in patients with secondary hyperoxaluria. ALLN-177 degrades oxalate in the gastrointestinal tract, which reduces the burden of dietary and endogenously produced oxalate.
ADC Therapeutics (ADCT) started a Phase I trial of its lead antibody drug conjugate (ADC) ADCT-301, a potential treatment for patients with acute myeloid leukaemia (AML).
The trial was designed to evaluate the tolerability, safety, pharmacokinetics and activity of ADCT-301 in patients with relapsed or refractory CD-25 positive AML.
ADCT-301 is composed of HuMax-TAC, a monoclonal antibody directed against the alpha chain of the IL-2 receptor (CD25) and conjugated to the company's potent proprietary pyrrolobenzodiazepine (PBD) dimer.
Around 30 patients will be enroled in the initial dose escalation phase at ten clinical sites across the US.
This will determine the recommended dose of ADCT-301 for the second stage, which will be expanded with 30 additional patients in the UK and Europe.
Matinas BioPharma Holdings started enrolling patients in its Phase IIa trial of MAT2203, a potential treatment for refractory mucocutaneous candidiasis infection.
The trial was being conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, US. Its principal investigator was Alexandra Freeman of the National Institute of Allergy and Infectious Diseases (NIAID) laboratory for clinical infectious diseases.
MAT2203 is an orally administered, encochleated formulation of the broad spectrum fungicidal medication amphotericin B. The company's lipid-crystal, nano-particle formulation of amphotericin B has a new absorption and distribution mechanism for treating infected tissues, and could potentially transform the way the fungicidal is administered.
Catabasis Pharmaceuticals collaborated with the Muscular Dystrophy Association (MDA) on its MoveDMD trial of CAT-1004, a potential treatment for Duchenne muscular dystrophy (DMD).
As part of the deal, MDA will provide transportation funding for patients travelling to participate in the trial.
The company reported positive top-line results for safety, tolerability and pharmacokineticsin from part A of the MoveDMD trial.
US-based biotechnology firm Juventas Therapeutics started enrolling patients in its Phase II trial (STOP-PAD) of JVS-100 to treat advanced peripheral artery disease (PAD).
JVS-100 is a gene therapy that encodes human stromal cell-derived factor-1 (SDF-1).
Around 120 patients were to be enrolled in the double-blind trial at about 25 US clinical centres.