February's top stories: Merck's Phase III HIV-1 trial results, NIH's Phase I AGS-v vaccine trial
Merck reported positive results from the Phase III trial of its non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine (MK-1439) for the treatment of patients with HIV-1 infection, and NIH's NIAID initiated a Phase I trial of vaccine AGS-v to prevent mosquito-transmitted diseases. Drugdevelopment-technology.com wraps up the key headlines from February.
Merck reported positive results from a pivotal Phase III clinical trial of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine (MK-1439) for the treatment of patients with HIV-1 infection.
The trial met its primary efficacy endpoint of the proportion of participants achieving levels of HIV-1RNA less than 50 copies/mL after 48 weeks of treatment, indicating the non-inferiority of once-daily doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each administered with tenofovir disoproxil fumarate / emtricitabine (TDF / FTC) or abacavir / lamivudine (ABC / 3TC), in previously untreated (treatment-naïve) adults with HIV-1 infection.
The determination of the secondary endpoint indicated that the doravirine-treated group had comparitively statistically lower levels of fasting low-density lipoprotein cholesterol (LDL-C) against the DRV+r group.
National Institute of Health (NIH) division the National Institute of Allergy and Infectious Diseases (NIAID) initiated a Phase I clinical trial of vaccine AGS-v to prevent a range of mosquito-transmitted diseases such as the Zika virus, malaria, West Nile fever and dengue fever.
Developed by UK-based pharmaceutical firm SEEK, AGS-v is an investigational vaccine designed to prevent the disease, as well as block the ability of mosquitoes to transmit such infections.
The vaccine was developed to trigger an immune response to mosquito saliva, instead of targeting a specific virus or parasite carried by mosquitoes.
The University of Liverpool collaborated with pharmaceutical firm AKL Research and Development to evaluate a new drug 'APPA' for the treatment of osteoarthritis (OA).
AKL identifies phytochemicals in natural products capable of being synthesised.
The previous trials identified two such molecules that act synergistically and have been combined to generate a patented drug APPA.
Australian-based MMJ PhytoTech's Israeli division PhytoTech Therapeutics initiated the Health Authorities-approved Phase II clinical trial of PTL101 capsules to treat refractory epilepsy in children.
Developed using MMJ's Gelpell-CBD product technology, the PTL101 capsules contain organically derived and purified cannabidiol (CBD) packed in natural gelatin beads under 2mm.
With maximised surface-to-volume ratio, the gelatin matrix pellets dispense over the gastrointestinal (GI) system to ensure a constant GI-transit time.
Boehringer Ingelheim Pharmaceuticals, a US subsidiary of German-based Boehringer Ingelheim, initiated the Phase II trial of afatinib (Gilotrif) and pembrolizumab (Keytruda) combination to treat patients with locally advanced or metastatic squamous cell carcinoma (SqCC) in the lung.
Afatinib is an oral tyrosine kinase inhibitor (TKI) designed to target cancer cells from within and block the signals required for tumour growth.
Conducted in collaboration with a subsidiary of Merck, the Phase II trial will evaluate the efficacy and safety of afatinib and pembrolizumab combination in approximately 60 patients.
Biopharmaceutical firm AstraZeneca announced positive results from its Phase III clinical trial (OlympiAD) of Lynparza (olaparib) to treat patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations.
Lynparza is an oral poly ADP-ribose polymerase (PARP) inhibitor expected to utilise tumour DNA damage response (DDR) pathway deficiencies to potentially destroy cancer cells.
Conducted in 19 countries across Europe, Asia, North America and South America, the randomised, multi-centre Phase III study compared the efficacy and safety of the drug in tablet form to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients.
The National University of Ireland (NUI) Galway initiated the Phase I clinical trial of daratumumab combination therapy in Irish patients for the treatment of multiple myeloma.
Patients in Ireland are the first to receive this new combination therapy.
Daratumumab (DARA) is a therapy being developed to treat multiple myeloma and is approved for the treatment of relapsed patients.
UK-based pharmaceutical firm GlaxoSmithKline (GSK) and US-based healthcare firm Innoviva reported positive headline results from a non-inferiority lung function study of relvar ellipta in patients with well-controlled asthma.
Relvar ellipta is a once-daily dual combination of inhaled corticosteroid fluticasone furoate and beta-2 agonist vilanterol in a single inhaler, the Ellipta.
The results showed that patients with well-controlled asthma were able to switch to the once-daily relvar ellipta 100/25 from the twice-daily seretide accuhaler 250/50 without any affect on their lung function.
US-based specialist bio-pharmaceutical company Emergent BioSolutions initiated the Phase Ib clinical trial of its anti-viral candidate UV-4B to treat dengue viral infection.
UV-4B is an iminosugar designed as an oral, broad spectrum antiviral to minimise virus infectivity by inhibiting a host glycosylation, which leads to misfolded viral glycoproteins.
Expected to enrol 40 healthy adults in the US sites, the multiple ascending dose Phase Ib trial is designed to evaluate the safety and tolerability of UV-4B.
US-based clinical stage biopharmaceutical firm began dosing in its Phase I, single ascending dose clinical study of MYK-491 to treat dilated cardiomyopathy (DCM).
The oral small molecule MYK-491 is currently being developed in an ongoing collaboration between MyoKardia and Sanofi and is an allosteric modulator of myosin, which improves cardiac contractility in a DCM heart.
Designed for hypertrophic cardiomyopathy, MYK-491 acts on the underlying bio-mechanical defects of the heart muscle.