COVID-19 Drug Research Roundup

COVID-19 Vaccines:

Moderna is giving people who participated in its phase 1 vaccine trial the option to receive a third booster shot through a new clinical trial set to begin in July, the company disclosed last week.

The German Centre for Infection Research and IDT Biologika say their COVID-19 vaccine candidate failed to demonstrate an expected immune reaction in an early-stage clinical trial. The trial was conducted in Hamburg and enrolled 30 volunteers. Disappointing findings from the trial will likely hold up IDT’s plans to seek regulatory approval for the vaccine by the end of this year.

Sinovac’s COVID-19 vaccine candidate was reported as 78 percent effective at preventing infection, but recent reports suggest the vaccine carries only a 50.4 percent efficacy rate. The previously reported 78 percent effectiveness rate was announced by the Butantan Institute, the organization responsible for conducting trials on the vaccine in Brazil. The data included cases of mild-to-severe COVID-19 and excluded patients with very mild infections. Once patients with very mild infections were included in the analysis, however, the efficacy rate dropped to 50.4 percent. This updated rate barely exceeds the World Health Organization’s 50 percent standard threshold for efficacy.

Findings from a phase 1/2a study show Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine Ad26.COV2.S produced detectable neutralizing antibodies in healthy adults by day 57. At day 29, the investigators observed neutralizing antibody titers against COVID-19 in more than 90 percent of participants following a single vaccination. Interim results of the early-stage trial show the vaccine, also referred to as JNJ-78436735, was well-tolerated and featured high immunogenicity at 5x1010 viral particles. This dose level was selected for additional investigation in the phase 3 ENSEMBLE trial. Local and systemic reactions occurred either on the day of immunization or the day after but usually resolved within a 24-hour period. J&J plans to file for Emergency Use Authorization for their vaccine pending results of the ENSEMBLE trial.

A phase 1/2 trial evaluating Valneva’s inactivated whole-virus COVID-19 vaccine candidate VLA2001 plans to use Oxford Immunotec’s T-SPOT Discovery SARS-CoV-2 test to measure the efficacy of the vaccine in healthy participants.

COVID-19 Therapies:

Studies on the effectiveness of convalescent plasma for treating COVID-19 have yielded conflicting results, with the majority of research pointing to its lack of efficacy in patients with severe disease. A new study from Imperial College London found that treatment with convalescent plasma does not reduce the risk of death or minimize the number of days on intensive-care support in patients with severe COVID-19. While the treatment wasn’t effective for improving disease-related outcomes in the 912 severely ill participants, it also wasn’t harmful. The Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) plans to expand its research into convalescent plasma in 4,000 severely ill patients.

A phase 2 clinical trial from Celltrion shows the South Korean company’s COVID-19 therapy, Regkirona, was more effective than other antibody treatments developed by Eli Lilly and Regeneron for treating COVID-19. The trial was conducted across 50 hospitals and included 327 patients with mild and moderate COVID-19. Celltrion plans to study the treatment candidate further in phase 3 trials pending a regulatory approval decision by the nation’s Ministry of Food and Drug Safety.

Roche’s Actemra and Sanofi’s and Regeneron’s Kevzara significantly reduced mortality by 24 percent in patients with COVID-19 who required intensive care, according to findings from an National Institute for Health Research-sponsored study in the UK. The study also found that the IL-6 inhibitors reduced hospital stays by 10 days in patients with COVID-19 who were admitted to intensive care. In contrast with these findings, results from trials in Italy and France found little to no benefit with Roche’s drug in patients with moderate-to-severe COVID-19.

DalCor Pharmaceuticals has launched a double-blind, placebo-controlled phase 2 study investigating dalcetrapib as a potential anti-viral COVID-19 treatment. The study’s main endpoints, efficacy and safety, will be assessed in three different dalcetrapib dose cohorts compared with placebo in up to 200 adult patients. Treatment will be administered over 10 days. Currently, dalcetrapib is undergoing investigation in a phase 3 cardiovascular trial.

Alexion Pharmaceuticals is pausing enrollment in its phase 3 study examining ravulizumab as a treatment for adults with severe COVID-19. The company is hitting the pause button after the study’s independent data monitoring committee found in the interim analysis that the therapy lacked appropriate efficacy when tacked onto best supportive care vs. best supportive care alone.

The first patient with COVID-19-induced chronic fatigue has been dosed with rintatolimod in AIM ImmunoTech’s active AMP-511 Expanded Access Program. The program plans to enroll up to 100 participants with active chronic fatigue syndrome, including 20 of whom may be “long haulers.” Researchers of the study suggest important observations related to the study treatment may be reported in May.

A phase 1/2 study involving 24 patients found that umbilical cord-derived mesenchymal stem cells (UC-MSCs) reduced the risk of death and expedited the time to recovery in patients with severe COVID-19. Patients in this study received UC-MSCs plus heparin and best supportive care. The one-month survival rate in the UC-MSC group was 91 percent compared with 42 percent in the control arm. Also, approximately 80 percent of patients who received UC-MSCs recovered by 30 days vs. 37 percent in the control group.

SaNOtize Research and Development has launched trials in the UK to study whether its SaNOtize Nitric Oxide Nasal Spray is effective against COVID-19. The nasal spray was developed to neutralize and eliminate SARS-CoV-2, the novel coronavirus responsible for COVID-19, in the upper airways and halt its progression to the lungs. Tests at Utah State University’s Antiviral Research Institute found the investigational nasal spray was 99.9 percent effective at killing the virus within a two-minute period.

Findings from an interim analysis of a Kintor Pharmaceutical trial show that treatment with Proxalutamide in female patients with COVID-19 significantly reduced the need for hospitalization, admission to intensive care, need for mechanical ventilation and death compared with placebo. The trial enrolled 168 women with COVID-19 who were treated with Proxalutamide plus standard care or placebo plus standard of care. The interim analysis included 60 patients in the Proxalutamide group and 35 patients in the placebo arm. Enrollment in the trial is expected to be complete by February, and data collection will conclude by March.

UK drugmaker Synairgen has dosed the first patient in a global phase 3 trial evaluating an inhaled formulation of interferon beta-1a, SNG001, for treating hospitalized COVID-19 patients who require supplemental oxygen.