Clinical Catch-Up: January 18-22

Clinical Trial Patient_Compressed

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. Read on to see.

COVID-19-Related

Gritstone Oncology, based in Emeryville, California, announced that it is advancing development of its own second-generation vaccine against COVID-19. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. It will be run through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), with support from the Bill & Melinda Gates Foundation.

Innovation Pharmaceuticals received the greenlight from the FDA to initiate a Phase II trial of Brilacidin in hospitalized COVID-19 patients. Brilacidin has shown in vitro to be have antiviral properties against different SARS-CoV-2 strains and other human coronaviruses. The drug appears to inhibit IL-6, IL-1beta, TNF-alpha and other pro-inflammatory cytokines and chemokines. It also has robust antimicrobial properties.

Researchers out of Brazil published a small study in the BMJ British Medical Journal that did not find the addition of Roche’s Actemra to standard of care to help the most severe cases. This is a different finding than in several previous trials, including a larger, 800-patient study that found significant benefit. The Brazilian study was designed to determine whether Actemra improved clinical outcomes for patients with severe or critical COVID-19. It was run at nine hospitals in Brazil from May 8 to July 17, 2020. It includes adults with confirmed COVID-19 on supplemental oxygen or mechanical ventilation with abnormal levels of at least two serum biomarkers, C reactive protein, D dimer, lactate dehydrogenase, or ferritin. The data monitoring committee recommended the trial be halted early after 129 patients had been enrolled, because there was an increased number of deaths at 15 days in the Actemra group.

Eli Lilly announced that its BLAZE-2 clinical trial conducted with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), of bamlanivimab (LY-CoV555) decreased the risk of COVID-19 among residents and staff of long-term care facilities, i.e., nursing homes. It evaluated 965 participants who tested negative for COVID-19 at baseline, 299 residents and 666 staff. All participants randomized to receive either 4,200 mg of bamlanivimab, Lilly’s neutralizing antibody, or placebo.

Non-COVID-19-Related

Biohaven Pharma completed a focused analysis of topline co-primary and key secondary data from its Phase II/III trial of troriluzole as a symptomatic treatment in mild-to-moderate Alzheimer’s disease. Additional secondary and exploratory efficacy analyses and biomarker data including neurofilament light chain (NfL), neurogranin, tau and amyloid are still pending. The drug did not differ statistically from placebo at 48 weeks on the prespecified co-primary endpoints on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 and the Clinical Dementia Rating Scale Sum of Boxes. Nor did it differentiate from placebo on the key secondary measure of hippocampal volume assessed by MRI.

Celyad Oncology updated its Phase I alloSHRINK trial of CYAD-101 for refractory metastatic colorectal cancer. CYAD-101 is the company’s allogeneic NKG2D-receptor and T cell receptor inhibitory molecule-based, non-gene edited CAR-T candidate. It is being administered together with FOLFOX chemotherapy. Two patients achieved a confirmed partial response and nine patients achieved stable disease, with seven demonstrating disease stabilization lasting more than or equal to three months of duration.

Ipsen announced results from new analyses of its pivotal Phase III trial to evaluate treatment intervals over repeat cycles of Dysport (abobotulinumtoxinA) in five patient populations. It shared 26 abstracts at the International Neurotoxin Association, including updates from the recently published surveys, data from the Phase IV ULIS-III trial, and 10 abstracts on basic science research into neurotoxins.

Caladrius Biosciences treated the first patient in its Phase IIb FREEDOM trial of CLBS16 for coronary microvascular dysfunction. The trial will investigate 105 patients for the drug, which is made up of autologous CD34+ cells.

Verrica Pharmaceuticals presented positive data from post-hoc pooled analyses of the pivotal Phase III CAMP trial of VP-102 in molluscum contagiosum. Patients treated with the drug with lesions in the upper extremities, head/neck, back/buttocks, and chest/abdomen at baseline demonstrated statistically significantly higher rates of complete clearance compared to the placebo group. VP-102 is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidim delivered by way of a single-use applicator.

Brickell Biotech announced efficacy and safety data from its Phase III trial with Kaken Pharmaceutical of sofpironium bromide in Japanese patients with primary axillary hyperhidrosis. Hyperhidrosis is a severe case of sweating.

Transgene and BioInvent received approval from France’s national regulatory agency to begin a Phase I/IIa trial of Vaccinia virus BT-001 in solid tumors. BT-001 is based on the patented Invir.IO oncolytic virus (VVcopTK-RR-) and engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody and the human GM-CSF cytokine.

Quantum Genomics launched its Phase III REFRESH trial in difficult-to-treat or resistant hypertension. The trial will evaluate a single dose of firibastat 1000mg compared to placebo, on top of the patients’ current therapy.

Evelo Biosciences announced new positive confirmatory data from its Phase Ib trial of EDP1815 in mild and moderate atopic dermatitis. The drug was well tolerated and demonstrated clinically meaningful improvement in the Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure IPOEM). The drug is an oral therapy for inflammatory diseases and effects multiple pathways, TH1, Th2 and Th17.

Ocuphire Pharma published results from its ORION-1 Phase II trial of Nyxol in glaucoma and presbyopia. The drug produced statistically significant 20% mean reduction or about 1 mm in pupil diameters under daytime and nighttime lighting conditions, and 60% demonstrated statistically significant improvement in a 1-line or greater in near visual acuity compared to 20% on placebo.

Histogen announced the FDA had verbally notified the company it had additional questions about its IND application for the planned Phase I/II trial of HST-003 for knee cartilage regeneration. The drug is a human extracellular matrix intended to regenerate hyaline cartilage for damaged joints. The company has not yet received written notice of its clinical hold from the FDA.

INmune Bio announced results from its Phase Ib trial of XPro1595 in Alzheimer’s disease. The drug decreased biomarkers of neuroinflammation across multiple measures and assays, including cerebrospinal fluid and MRI. XPro1595 is a dominant-negative protein that neutralizes soluble TNF, which is to say, it’s a next-generation tumor necrosis factor inhibitor, but doesn’t behave the way currently existing TNF inhibitors do.

Transgene dosed the first patient in its Phase I trial of TG4050 (myvac Platform) in a patient with head and neck cancer. TG4050 is an individualized immunotherapy for solid tumors based on the company’s myvac technology and leveraging NEC’s artificial intelligence expertise. It is a virus-based therapeutic vaccine that encodes neoantigens picked by NEC’s Neoantigen Prediction System.

GlaxoSmithKline halted and discontinued its Phase II trial of GSK2831781 for ulcerative colitis. The drug was licensed from Immutep Limited. The drug is a monoclonal antibody designed to deplete recently activated LAG3 expressing T-cells in T-cell driven immuno-inflammatory disorders. The trial was halted and abandoned after an interim evaluation by an IDMC. No details about the concerns were disclosed.

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