Clinical Catch-Up: May 3-7
It was a busy week for clinical trial news. Here’s a look.
Covis Pharma Group announced topline data from a 400 patient Phase III trial of ciclesonide metered-dose inhaler in non-hospitalized COVID-19 patients 12 years of age and older with symptomatic COVID-19 infection. A subgroup analysis demonstrated that time to alleviation of cough was the most improved symptom in the cyclesonide arm compared to placebo by six days in 75% of the population. Otherwise, the changes were not statistically significant. A 70% reduction was observe din the cyclesonide arm versus 30% in the placebo arm of patients with subsequent emergency department visits or hospital or hospital admissions for reasons attributable to COVID-19 by Day 30. This was a secondary endpoint.
AbCellera announced that a second antibody from its collaboration with Eli Lilly entered clinical trials in patients with mild-to-moderate COVID-19. Lilly has expanded its BLAZE-4 trials to evaluate LY-CoV1404 alone and together with other monoclonal antibodies.
Novavax announced it has expanded its Phase III trial of its COVID-19 vaccine to include children between the ages of 12 and 17. The vaccine has yet to be authorized anywhere in the world or submitted for authorization in the U.S. It is undergoing rolling review in Europe. It is being tested now on about 3,000 children at 75 locations in the U.S. It is a two-shot vaccine taken 21 days apart.
Humanigen released pre-print data from its Phase III trial of lenzilumab in hospitalized COVID-19 patients. The data demonstrated the drug increased survival without needing ventilation in 90% of hospitalized COVID-19 patients. Lenzilumab is a novel Humaneered anti-human GM-CSF monoclonal antibody that directly binds GM-CSF and prevents signaling through its receptor.
CytoDyn is partnering with Academic Research Organization (ARO) – Albert Einstein Israelite Hospital (AEIH) in Sao Paulo, Brazil for two COVID-19 trials. They will evaluate the company’s leronlimab, a CCR5 antagonist, for multiple therapeutic indications.
Synairgen announced results from the Home Cohort of its SG016 Phase II trial of SNG001 in COVID-19 patients and data from the combined analysis of the Hospital and Home Cohorts. SNG001 is a formulation of IFN-beta for nebulization. In the Hospital Cohort, patients receiving the drug were twice as likely to recover from severe lower respiratory tract (LRT) illness to the point they had no limitation of activities without rebound compared to placebo. The Home Cohort had a lower at-risk patient population than anticipated, and prevention of severe LRT infection could not be determined.
GenSight Biologics published the final results of the REALITY Leber Hereditary Optic Neuropathy (LHON) Registry study. The study analyzed the natural history visual outcomes of patients with LHON who carried one of the three primary mitochondrial DNA (mtDNA) mutations that cause about 90% of all cases.
Mayne Pharma announced results from two studies showing that treatment with Nextstellis (drospirenone/estetrol) demonstrated contraceptive efficacy and excellent cycle control across subgroups. It is the first contraceptive pill containing E4, a new naturally occurring estrogen with a unique mechanism of action.
Revolo Biotherapeutics announced positive data from a multiple ascending dose Phase I trial of ‘1104, for allergic disease. The drug is a first-in-class peptide and the data showed it was safe and well-tolerated at the two doses studied, 4 and 8 mg.
Rezolute announced positive topline data from its first-in-human Phase Ia trial of RZ402. RZ402 is an investigational oral plasma kallikrein inhibitor (PKI) for treatment of diabetic macular edema (DME).
Soleno Therapeutics presented positive behavioral outcomes data from its ongoing open-label extension of DCCR (diazoxide choline) Extended-Release tablets for patients with Prader-Willi Syndrome (PWS). Through 48 interviews, 29 behavioral outcomes were identified in seven outcome domains, with an average of 22 plus or minus 5.9 behaviors reported. The most frequently reported domains were Food-seeking Behaviors (100%), Mealtime Behaviors (98%), and Daily Life Behaviors (98%). PWS is a genetic disease marked by hyperphagia, a chronic feeling of insatiable hunger. It also includes behavioral problems, cognitive disabilities, low muscle tone, short stature, excess body fat, developmental delays, and incomplete sexual development.
Recce Pharmaceuticals announced RECCE 327 demonstrated bactericidal activity against all six antibiotic resistant ESKAPE pathogens, including drug resistant mutations, and two more WHO priority pathogens list. ESKAPE are dubbed such because of their tendency to “escape” the action of antibiotics and are responsible for more than 72,000 hospital-acquired infections in the U.S. alone annually. The ESKAPE pathogens include: E. facium, S. aureus, K pneumonia, A. baumanii, P. aeruginosa, and Enterobacter species.
Vaxart enrolled the first patient in a Phase Ib boosting regimen trial of its norovirus vaccine candidate. The vaccine is a VP1-based bivalent oral tablet vaccine that targets the norovirus GI.1 Norwalk and GII.4 Sydney strains.
Arcutis Biotherapeutics presented efficacy and safety data from the DERMIS-1 and 2 pivotal Phase III trials of roflumilast cream for chronic plaque psoriasis. The identical trials hit their primary endpoint of IGA Success at week 8.
Incyte presented multiple abstracts about ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, in atopic dermatitis. The company presented five posters or presentations on the drug at the Society for Investigative Dermatology (SID) Virtual Meeting 2021.
Genascence Corporation completed dosing across three cohorts in its Phase I trial of GNSC-001 for osteoarthritis. GNSC-001 is an AAV gene therapy that carries code for interleukin-1 receptor antagonist (IL-1Ra).
Veru presented Phase II data of its study of enobosarm in heavily pretreated women with AR+ER+HER2- advanced breast cancer. Even though they had progressed on standard of care, patients receiving enobosarm demonstrated significant clinical responses. Enobosarm is an oral selective androgen receptor targeting agonist.
BGG World completed and published data on its study of a synergistic combination containing 22mg MyrtiPro BGG’s standardized bilberry extract containing 36% of anthocyanins by HPLC, 6mg AstraZine Natural Astaxanthin, and 10mg Lutein. The study was in 44 healthy subjects experiencing eye fatigue while working at computer screens for six weeks. Statistically significant results were found in the treatment group on key areas of eye health, including improved vision, decrease of trouble focusing, and improvement in percentage of pupillary response.
Neoleukin Therapeutics dosed the first patient in a Phase I trial of NL-201 for advanced solid tumors. NL-201 is a de novo protein that mimics the activity of natural cytokines IL-2 and IL-15.
Catalyst Biosciences dosed the first patient in the Crimson 1 Study, its Phase III trial of Marzeptacog alfa (activated) for Hemophilia A or B with inhibitors. MarzAA is a subcutaneously administered next generation engineered recombinant coagulation Factor VIIa (rFVIIa).
TILT Biotherapeutics dosed its first patients and progressed to a second dose level in a monotherapy Phase I trial of TILT-123 in injectable solid tumors. TILT-123 is a dual cytokine armed oncolytic adenovirus.
NervGen Pharma dosed the first patient in its Phase I trial of NVG-291 in Australia via Novotech Pty Limited. The drug is an inhibitor of PTPσ, a potential target for decreasing the clinical effects of nerve damage.
Hepion Pharmaceuticals completed recruitment for its Phase IIa AMBITION trial of CRV431 in non-alcoholic steatohepatitis (NASH). CRV431 is a potent inhibitor of cyclophilins.
Palisade Bio and Newsoara completed a Phase II trial of LB1148 for accelerating return of bowel function associated with gastrointestinal surgery. LB1148 is an oral, broad-spectrum serine protease inhibitor.