GlaxoSmithKline’s Nucala Achieves Co-Primary Endpoints
GlaxoSmithKline (GSK) announced that its drug candidate Nucala met co-primary endpoints for the pivotal SYNAPSE study. The trial was designed to assess the efficacy of this asthma drug in treating patients with nasal polyps associated with chronic rhinosinusitis. This late stage trial combined the drug with standard of care. The company intends to use this data for supporting its regulatory submissions later this year.
GlaxoSmithKline stated that this is the first time an anti-IL5 biologic has produced positive results in Phase 3 trials pertaining chronic rhinosinusitis. The co-primary endpoints pertained to the size of nasal polyps at week 52 and nasal obstruction during weeks 49 to 52. The drug candidate showed statistically significant improvement on both the accounts. It also showed statistically significant progress for the time to first actual nasal surgery up to week 52, which constituted key secondary endpoint for the trial.
SYNAPSE is the first trial aimed at assessing the use of biologic for treating patients with previous history of surgeries and requiring further surgery due to severe symptoms and increase in the size of their polyps. GSK chief scientific officer and R&D president Hal Barron said, “These results show that Nucala can reduce symptoms and need for surgery in patients with nasal polyps, and we look forward to progressing this regulatory submission.” Nasal polyps are a common condition but may negatively impact functions such as breathing and sleeping.
The Phase 3 trial was aimed at evaluating the efficacy and safety of the liquid form of Nucala 100mg used in conjunction with standard of care. The trial encompassed more than 400 adult patients suffering from recurrent severe bilateral polyps.
However, Nucala is not the only news from GlaxoSmithKline’s side. The company also announced that it is upping its stake in fight against coronavirus by making a $250 million equity investment in Vir Biotechnology (NASDAQ:VIR). The collaboration will entail the use of Vir’s proprietary monoclonal antibody platform technology for accelerating existing and identifying new anti-viral antibodies. GlaxoSmithKline will be responsible for providing their expertise in Artificial Intelligence, CRISPR screening and functional genomics. The deal valued Vir stock at $37.73 apiece, providing a considerable premium over its Friday closing price of $29.
Vir Chief Executive Officer George Scangos said, “It is becoming increasingly clear that multiple therapeutic approaches, used in combination or in sequence, will be necessary to stop this coronavirus pandemic. It is likely that the current coronavirus outbreak will not be the last.” However, this is not the only coronavirus initiative by GlaxoSmithKline. The company is also collaborating with Clover Biopharmaceuticals as well as with AstraZeneca Plc (NYSE:AZN).
GlaxoSmithKline will be using its adjuvant system for developing vaccines along with Epidemic Preparedness Innovations. The system aims to increase the body’s immune reaction to provide more robust and enduring protection. Currently, more than 100 off the shelf and experimental therapies are under evaluation for their use in combating the pandemic.
Incyte Reports Positive Data from Phase 3 Ruxolitinib Trial
Incyte Corp. (INCY) reported results for two Phase 3 clinical trials for Ruxolitinib. The trials namely TRuE-AD1 and TRuE-AD2 were carried out for assessing the efficacy of Ruxolitinib in adults and adolescents suffering from atopic dermatitis. The company reported that both the trials met their primary endpoints. Incyte reported that there are no observable new safety signals from the trial. The standard of care topical treatment for AD is corticosteroid creams, ointments or lotions.
The primary endpoint for the trials was showing a statistically significant proportion of treated patients achieving clear or almost clear skin at week 8 compared to vehicle cream (placebo). In TRuE-AD1 trial 50 percent of the patients who received twice daily applications of 0.75 percent Ruxolitinib cream demonstrated clear or almost clear skin compared to 15.1 percent of the participants in the placebo group showing the same results. For TRuE-AD2, the respective proportions were 39 percent and 7.6 percent. At 1.5 percent dosage, the cream achieved the primary endpoint in 53.8 percent and 51.3 percent patients in the trials.
Incyte also reported that patients who were treated with the drug candidate demonstrated statistically significant reductions in itching as measured by a scale called NRS score. Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte said, “We are pleased to share these important data with the dermatology community, as they support the potential of Ruxolitinib cream to become an important antipruritic and anti-inflammatory treatment option for patients with atopic dermatitis.” The company plans to file the New Drug Application with the FDA later in 2020.
The trial demonstrated the overall safety profile of the drug to be consistent with previous studies. However, the company is currently evaluating the long-term safety profile of the cream under the 44 week extension period of both studies. The TRuE-AD clinical trial program comprises two randomized, dose ranging Phase 3 studies. These studies are also double blind and vehicle controlled.
XBiotech Stock Shoots Up After Plasma Program Update
XBiotech (XBIT) reported that it will be collaborating with BioBridge Global for collecting and distributing convalescent plasma taken from people who have recovered from COVID-19 infection. BioBridge Global is a non-profit organization and the collaboration falls under an FDA program. Plasma collected this way may be used for treating patients with serious and/or life threatening COVID-19 infection.
Under this collaboration, QualTex Laboratories, a subsidiary of BioBridge Global, will use the clinical test developed by XBiotech for identifying natural antibodies found in human blood which may provide defense against the virus causing COVID-19. Dr. Sushma Shivaswamy, Ph.D, XBiotech’s Chief Scientific Officer said “Our unique human antibody technology at XBiotech has been developed specifically to address these kinds of issues. We are humbled to be able to support BioBridge Global in its effort to use human convalescent donor blood to provide remedies for patients hospitalized with this deadly disease.” With this testing technology, QualTex will be able to recognize blood that contains naturally neutralizing antibodies against the virus.
South Texas Blood & Tissue Center, another BioBridge Global subsidiary, will be responsible for collecting the plasma from these donors. The Center will also provide blood samples to XBiotech to aid the development of True Human antibody therapy aimed at combating COVID-19. XBiotech is currently working on transferring the testing technology to QualTex. The company is also working towards providing training to its laboratory workers to enable them to carry out the assay in San Antonio laboratory.
XBiotech is mainly involved in the discovery and development of therapeutic antibodies. Its True Human antibodies are currently the only antibodies derived without modification from humans who possess natural immunity to certain diseases.
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