Clinical catch-up dates: 7.-11. February | bioroom


It’s been a relatively quiet week for clinical trial news, although things seemed to be picking up a bit for COVID-19-related announcements. Here’s a look.

COVID-19 related

Celltrion Group submitted an Investigational New Drug (IND) application to conduct a global phase III study of an inhaled antibody cocktail against mild to moderate COVID-19. They plan to enroll 2,200 patients around the world. It is a combination of two monoclonal antibodies, regdanvimab (CT-P59) and CT-P63, and is designed to target emerging mutations, including the Omicron variant.

Adamis Pharmaceuticals announced enrolling and dosing more than 100 participants in its ongoing phase II/III study of Tempol for COVID-19. The Data Safety Monitoring Board (DSMB) is to examine the clinical and safety data of the first 50 subjects as part of the first interim analysis.

Pfizer specified it had halted development of the intravenous variant of the drug, PF-07304814. PF-07304814 is a primary protease inhibitor of SARS-CoV-2, the same mechanism of action as either drug in Paxlovid.

SaNOtize Research & Development Corp. and This was announced by Glenmark Pharmaceuticals Results of a phase III study of SaNOtize’s nitric oxide nasal spray (NONS). The study met its primary endpoint, showing a reduction in logarithmic viral load of SARS-CoV-2 of more than 94% within 24 hours of treatment and more than 99% within 48 hours. It has been shown to be safe and effective, shortening the course of the disease and potentially preventing transmission of the virus.

Johnson&Johnson released the final analysis of a phase III study of its COVID-19 vaccine in The New England Journal of Medicine. This was the single-dose version in 39,185 participants. 8,940 of them were followed up for at least six months.

Vaccine efficacy in the overall population against COVID-19 with moderate to severe disease was 56.3% at least 14 days after administration. At least 28 days after administration, the vaccine efficacy was 52.9%. The effectiveness decreased compared to the gamma, lambda and mu variants. Efficacy against severe-critical COVID-19 was 74.6%, 75.6% against COVID-19 that led to medical intervention including hospitalization, and 82.8% against COVID-related death, with six months of protection or longer. No new safety concerns were identified.

Based on the data from the study, there were insufficient data to determine the vaccine’s efficacy against the Delta variant or the Omicron variant, although efficacy ranged from 50% to 94% against Delta hospitalizations and 52% to 82% against deaths during the period lay where delta was common.

Novavax reported that the Phase III trial of its COVID-19 vaccine showed promising data in adolescents aged 12 to 17. It achieved an overall efficacy of 80% during the PREVENT-19 study conducted during the delta rise.

Kintor Pharma dosed the first patient in China in its phase III trial of proxalutamide for COVID-19. The drug is a nonsteroidal antiandrogen, specifically a selective silent antagonist with high affinity of the androgen receptor.

Not COVID-19 related

Evelo Life Sciences announced Immunobiomarker analysis results from its phase II study of EDP1815 in mild and moderate psoriasis. A reduction in cytokine release was noted compared to placebo. EDP1815 is an oral drug containing a non-living pharmaceutical preparation of a strain of Prevotella histicola.

Alnylam initiated a phase I study of ALN-APP in early-onset Alzheimer’s disease. ALN-APP is an RNAi therapeutic that targets the amyloid precursor protein.

Brains Bioceutical Corp and the Icahn School of Medicine at Mount Sinai in NYC initiated a clinical PK study with EU-GMP grade CBD API. The early data will be used for potential future clinical trials in opioid addiction and related disorders.

CureVac dosed became the first patient in a Phase I study of its second-generation seasonal influenza mRNA vaccine candidate, CVSQIV, with which it was developed GlaxoSmithKline. The vaccine contains several non-chemically modified mRNA constructs to induce immune responses.

Merck published Results from the Phase III KEYNOTE-522 study of neoadjuvant Keytruda (pembrolizumab) in combination with chemotherapy followed by adjuvant Keytruda monotherapy showed that the regimen improved event-free survival compared to neoadjuvant chemotherapy followed by adjuvant placebo in the early stage high-risk significantly prolonged triple-negative breast cancer. Keytruda is an anti-PD-1 checkpoint inhibitor.

Phantom Pharmaceuticals reported positive topline data from the Phase II PHALCON-NERD study of three dose levels of vonoprazan as an on-demand treatment for the relief of episodic heartburn in people with non-erosive gastroesophageal reflux disease (NERD). All three doses met the primary endpoint. The drug is an oral low molecular weight potassium-competitive acid blocker.

Sanofi reported positive results from its long-term, open-label extension studies of olipudase alfa resulted in sustained improvements in lung function and decreased spleen and liver volumes in adults and children with non-CNS manifestations of acid sphingomyelinase deficiency (ASMD). Olipudase alfa is an enzyme replacement therapy that replaces deficient or defective ASM.

This was announced by SCYNEXIS positive data from its phase III CANDLE study of oral Ibrexafungerp in the prevention of recurrent vulvovaginal candidiasis or vaginal yeast infection. It expects to submit data to the FDA in the first half of this year. The drug is an oral fungicide.

Roche reported promising two-year data from phase III studies of Susvimo ​​(formerly known as the Port Delivery System with ranibizumab) and Vabysmo (faricimab). The data supported the drugs’ potential to improve the quality of life of patients with diabetic macular edema (DME) and neovascular or wet age-related macular degeneration (nAMD).

Oxurion presented data from Part A of the two-part Phase II KALAHARI study of THR-149 in diabetic macular edema. The drug is a potent plasma kallikrein inhibitor.


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