Clinical Catch-Up: May 18-22
Many of us look forward to a day when clinical trial news related to COVID-19 isn’t a separate category, but we’re not quite there yet. However, non-COVID-19 clinical trial updates are outweighing COVID-19 studies, particularly with the American Society of Clinical Oncology meeting coming up soon. Here’s a look.
Moderna released positive interim Phase I data from its clinical trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19. The vaccine furthest along in human trials showed positive results for both efficacy and safety, overall.
Data for immunogenicity was available for two doses, 25 ug and 100 ug after two doses, with the immunogenicity tested on day 43, and the 250 ug dose after a single dose, tested at day 29. All the patients in this trial were healthy and between the ages of 18 and 55.
All the patients in the trial, 15 in each cohort, seroconverted by day 15 at a single dose. At day 43, which was two weeks after the second dose, all the patients with the 25 ug dose showed antibody levels in their blood at the same levels observed in the blood samples from people who have recovered from COVID-19. In patients receiving the 100 ug dose, the antibody levels were significantly higher at day 43 that that seen in recovered patients’ blood.
Currently, neutralizing antibody data (compared to binding antibody data, above) is only available for the first four patients in each of the 25 ug and 100 ug cohorts. The data, however, is consistent with the binding antibody data. The two different analyses are to determine how well the antibody attaches to the virus and how well it kills or neutralizes the virus.
ORYZON Genomics enrolled the first patient in its Phase II trial of vafidemstat in seriously ill COVID-19 patients. The ESCAPE study will evaluate vafidemstat in combination with standard of care to prevent progression to Acute Respiratory Distress Syndrome (ARDS). Vafidemstat is an oral, CNS optimized LSD1 inhibitor, which decreases cognitive impairment, being developed for Alzheimer’s and multiple sclerosis, as well as other psychiatric disorders. The drug also appears to decrease inflammation.
CytoDyn plans to submit a protocol to the FDA for a trial comparing the effectiveness of its leronlimab compared to Gilead’s remdesivir and in combination with remdesivir for the treatment of COVID-19. Preliminary results from its leronlimab trial in 60 COVID-19 patients led to the company’s Phase IIb/III trial for 390 patients. It also has approval for a Phase II trial for mild-to-moderate COVID-19 patients in the U.S. The company also announced it will be coordinating with the NIH of Mexico and providing leronlimab for a clinical trial for severe/critical COVID-19 patients in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials. CytoDyn is currently enrolling a Phase IIb/III clinical trial for 390 patients, as well as a Phase II trial with 75 patients.
BioSig Technologies and its subsidiary ViralClear Pharmaceuticals, received clearance from the FDA for its IND for a proposed Phase II trial of merimepodib in adults with hospitalized COVID-19. Merimepodib is a broad-spectrum antiviral candidate that showed strong activity against COVID-19 in cell cultures. It was previously in development for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals.
Progenabiome is launching two FDA-approved clinical trials that include hydroxychloroquine to prevent or treat COVID-19.
Kancera submitted an application to the Swedish Medicines Agency to run a Phase II trial of KAND567 in COVID-19 patients. The goals it to determine if the drug can slow hyperinflammation and avoid the intensive care treatment and long-term rehabilitation of COVID-19 patients. It is expected to be conducted with Capio St. Gorans Hospital and the Science for Life Laboratory. KAND567 blocks the Fractalkine receptor, which plays a key role in the body’s immune system and inflammation.
Researchers at Brigham and Women's Hospital in Boston and international colleagues published the results of a study of 96,032 hospitalized COVID-19 patients, evaluating whether the use of antimalarial drugs chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, were helpful in battling the disease. They found that of the 15,000 patients who received either of the drugs were almost twice as likely to die compared to the patients who did not receive them. The research was published in the journal The Lancet.
Nemechek Technologies registered a clinical trial to study transcutaneous vagus nerve stimulation (tVNS) in patients with moderate, severe, or critical pneumonia associated with COVID-19. The theory is that electrical stimulation of the vagus nerve, known as the Inflammatory Reflex, might decrease the cytokine reaction. The study would use the company’s Vitality Smartcable tVNS device to suppress pro-inflammatory cytokines and improvement patient outcomes.
ChemoCentryx and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced topline data from a Phase II study in primary Focal Segmental Glomerulosclerosis (FSGS). The LUMINA-1 trial evaluated CCX140 in primary FSGS patients. CCX140 is an orally-administered selective inhibitor of the chemokine receptor, CCR2. The drug failed to show a meaningful reduction in proteinuria relative to the control group.
Zai Lab dosed the first Chinese patient in the global ATTACK Phase III trial of the combination of sulbactam and durlobactam (SUL-DUR) for the treatment of carbapenem-resistant Acinetobacter baumannii infections. It will enroll about 300 patients with pneumonia and bloodstream infections caused by the bacteria, with a data readout expected in early 2021.
Biohaven Pharma presented data from 25 accepted abstracts at the 2020 American Academy of Neurology (AAN) Science Highlights virtual platform. They are all related to the efficacy, safety, tolerability and pharmacoeconomic value of Nurtec (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet approved for migraine in the US.
EyePoint Pharmaceuticals presented positive respective case study data in support of Dexycu (dexamethasone intraocular suspension) 9% for post-operative inflammation after ocular surgery. They presented three electronic posters and one oral paper at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting on May 16-17. The trial is expected to enroll up to 600 patients at about 40 study sites.
TLC published data from subgroup analyses from the Phase II trial of TLC599 in osteoarthritis knee pain. It showed a pattern of efficacy, with greater reductions in pain with TLC599 than in the placebo group from Week 1 through Week 24. It was accepted as an abstract at Osteoarthritis Research Society International (OARSI) 2020 and published in the Osteoarthritis and Cartilage journal.
ViiV Healthcare, owned by GlaxoSmithKline, Pfizer and Shionogi, announced interim analysis of the HIV Prevention Trials Network (HPTN) 083 trial of cabotegravir for HIV prevention. The drug was found to be 69% more effective in preventing HIV in men who have sex with men (MSM) and transgender women who have sex with men compared to the current standard of care, daily oral emtricitabine/tenofovir disoproxil fumarate. It met its primary objective of non-inferiority. The DSMB recommended the blinded, randomized portion of the trial be stopped early and results released.
Biogen announced additional data from the Spinraza (nusinersen) clinical development program demonstrating the sustained efficacy and longer-term safety of Spinraza in spinal muscular atrophy (SMA). The SHINE study enrolled 292 patients from five previous Spinraza trials, including ENDEAR. The study showed treatment with the drug resulted in motor function improvement or disease stabilization in toddlers, children and young adults.
Vivex Biologics presented clinical results from the VAST study, a 12-month trial evaluating VIA Disc for patients with one- or two-level symptomatic degenerative disc disease (DDD). VIA Disc is a non-surgical, injectable intradiscal treatment for patients with chronic discogenic lower back pain resulting from DDD.
Beyond Air announced positive topline results from its third pilot study in bronchiolitis patients. The data showed on an intent-to-treat (ITT) basis, 150 parts per million (ppm) nitric oxide (NO) that is statistically significant compared to both the 85 ppm NO and control arms of the study. Beyond Air develops inhaled NO for patients with respiratory conditions and gaseous NO for solid tumors.
Fate Therapeutics announced the FDA had cleared its IND application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. The drug is an off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity—a high-affinity, non-cleavable CD16 Fc receptor; an IL-15/IL-15 receptor fusion; and the elimination of CD38 expression. The company expects to initiate a clinical trial of three once-daily doses as a monotherapy in acute myeloid leukemia and in combination with daratumumab for multiple myeloma.
Cidara Therapeutics dosed the first patient in its ReSPECT pivotal Phase III trial of rezafungin for the prevention of invasive fungal diseases in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin.
LivaNova published new study data showing its Vagus Nerve Stimulation Therapy (VNS Therapy) to treat as usual (TAU) significantly improved outcomes in patients with treatment-resistant bipolar depression (TRBD). The study showed that VNS Therapy as an adjunctive treatment to TAU was more effective than TAU alone in decreasing depressive symptoms and suicidal ideation.
Geron Corporation announced plans for a Phase III trial in refractory myelofibrosis patients who are refractory to treatment with a Janus kinase (JAK) inhibitor. It will compare imetelstat to best available therapy that excludes JAK inhibitors and has overall survival as the primary endpoint. Imetelstat is a novel, first-in-class telomerase inhibitor.
Gilead Sciences and Galapagos NV announced positive topline data from a Phase III trial of filgotinib. Filgotinib is a once-daily, selective JAK1 inhibitor. The topline data showed a higher dose of the drug achieved the desired results compared to placebo in the induction and maintenance of remission in the SELECTION Phase IIb/III trial in biologic-naïve or biologic-experienced adults with moderately to severely active ulcerative colitis.