Pfizer’s RSV Vaccine enters in the late-stage of clinical trials 

As the battle to get an effective Respiratory Syncytial Virus (RSV) vaccine on the market heats up, Pfizer is launching a critical late-stage study of its experimental vaccine against a severe version of a cold virus that may cause pneumonia and death in the young and elderly. Recently, the US Food and Drug Administration has fully authorized its SARS-CoV-2 or COVID-19 vaccine.

The RSVpreF Phase 3 RENOIR trial is a worldwide, randomized, double-blind, placebo-controlled study that will recruit about 30,000 people aged 60 and up. The study’s major goals will be to evaluate the safety and effectiveness of msLRTI-RSV for the prevention of moderate to severe lower respiratory tract disease (msLRTI-RSV) during the first RSV season.

Respiratory Syncytial Virus is a seasonal virus that often begins in the autumn and peaks in the winter when colds and other respiratory disorders are more prevalent. RSV is often confused with COVID-19 owing to similar symptoms. According to the CDC, by the age of two, the majority of children experienced an RSV infection. While most individuals recover in one to two weeks, RSV can be fatal in babies and the elderly.

Forte Biosciences’ lead asset fails in phase II clinical trials for Atopic Dermatitis

California-based pharma company Forte has been testing FB-401, which comprises three therapeutic strains of a commensal gram-negative bacteria, as a possible therapy for atopic dermatitis. 

The main endpoint of Eczema Area and Severity Index (EASI)-50 was met by 58 percent of patients treated with FB-401 vs 60 percent of those given a placebo. 

Forte previously completed a phase 1/2a research in children and adults, which showed that the medication greatly improved the condition and itching while removing the need for steroid treatment. Forte had hoped for at least a 50% improvement in the severity of atopic dermatitis, but the findings fell short of that key aim.

Based on the findings of the phase II trial, the company intends to stop the development of FB-401 for this indication. As a result, the stocks of Forte Biosciences’ dropped more than 80% in premarket trading. 

The flagship programme of Bone Therapeutics fails in Osteoarthritis

Bone Therapeutics is working to create a next-generation intra-articular injection to treat knee osteoarthritis. JTA-004, which is being developed to give extra lubrication and protection to the cartilage of the arthritic knee joint in an attempt to relieve osteoarthritic pain, was evaluated in the Phase III trial.

The primary goal of the JTA-004 Phase III trial was to show that JTA-004 was more effective than placebo in decreasing osteoarthritic knee pain as evaluated by the WOMAC® pain subscale three months following therapy. An important secondary goal was to compare JTA-004 to the comparator Hylan G-F 20 in terms of knee pain reduction at three months. Despite JTA-004’s favorable safety profile, it failed to demonstrate a statistically significant difference in pain reduction against both placebo and the comparator drug in the study.

Bone Therapeutics is also concentrating its efforts on the advancement of its key assets, the allogeneic cell treatment platform, which includes ALLOB. ALLOB is being studied in a Phase IIB trial with fresh tibial fractures that are at risk of delayed or non-union. The study will look at the possibility of using a single injection of ALLOB as a therapy to speed up fracture healing and avoid late-stage problems in these individuals. The IIb study’s topline findings are expected in the first half of 2022.

Johnson & Johnson HIV vaccine trial halts in the middle of the research

A Johnson & Johnson HIV vaccine candidate failed to lower the risk of infection in a clinical study, marking yet another failure in the decades-long scientific search for an HIV vaccine. The HIV vaccine developed by Johnson & Johnson employs the same underlying “viral vector” technology as the company’s current COVID-19 vaccine.

The study ‘Imbokodo’ included 2,600 women in southern Africa who were at extremely high risk of HIV infection. It was co-sponsored by the Bill and Melinda Gates Foundation and the U.S. National Institutes of Health. The study was launched in 2017 and it was announced that the previous year, all individuals were given either a vaccination or a placebo. The vaccine’s objective was not to fully prevent infection, but rather to cut the risk in half.

Another late-stage trial, Mosaico, will continue to evaluate a slightly modified vaccination regimen in males who have sex with men and transgender persons in the Americas and Europe.

Versanis Bio Announces $70 Million Series A Financing to Advance Bimagrumab for Obesity Treatment

Versanis Bio, an Oakland, Calif-based company has licensed Novartis’s Bimagrumab drug rights and raised $70 million for mid-stage clinical testing. Aditum Bio, a biotech investment business, also seeded and funded the company earlier this year with the goal of developing a novel therapeutic for metabolic disease and obesity.

Novartis developed Bimagrumab in cooperation with MorphoSys. Bimagrumab is an antibody that binds to the activin receptor type II, which is one of a family of receptors involved in a variety of cell activities. Binding to this receptor was designed to prevent inhibitory compounds from binding.

The drug was developed by Novartis as a therapy for a variety of muscle-wasting diseases. Novartis and MorphoSys announced in 2016 that the medication failed a Phase 2b/3 trial in sporadic inclusion body myositis, a rare disease that causes increasing muscular weakness.

Novartis and MorphoSys evaluated Bimagrumab on over 1,500 patients, demonstrating that the medication is safe. Despite the failure in muscular diseases, Novartis kept the medication in clinical trials to learn more. 

Versanis will now attempt to duplicate the Novartis study’s findings. The Series A funding will be used to fund a comprehensive Phase 2 clinical research to evaluate the drug’s capacity to assist obese people in shed weight.

AC Immune’s potential Alzheimer’s antibody yields mixed results in phase II trials

AC Immune, a Swiss company, and its partner Genentech have announced that their candidate Semorinemab is the first tau-targeting monoclonal antibody to show clinical efficacy in Alzheimer’s disease.

Top-line findings from the phase 2 Lauriet study indicated that the therapy met one of its co-primary objectives, decreasing cognitive deterioration by 43.6 percent from baseline compared to placebo in patients with mild to severe Alzheimer’s disease. However, the therapy did not achieve its second co-primary goal (lowering the rate of functional deterioration from baseline) or two secondary efficacy endpoints. 

Alzheimer’s disease is in the limelight following the contentious approval of Biogen Inc.’s Aduhelm in the United States, which is viewed as a favorable indication for other drugmakers such as Roche. Despite the mixed results, AC Immune’s stock soared 73 percent in premarket trading to $12.15.