All articles tagged with #phase iii trial
The Bill & Melinda Gates Medical Research Institute has launched a Phase III trial in South Africa to test an experimental tuberculosis vaccine's ability to prevent latent infections from developing into potentially deadly lung disease. The study, with an estimated cost of $550 million, is being funded by the Wellcome Trust and the Gates Foundation.
Amylyx's FDA-approved ALS drug, Relyvrio, has failed a crucial Phase III trial, prompting the company to consider withdrawing the drug. In a study of 664 ALS patients, the drug did not outperform a placebo and missed all secondary outcomes, including quality-of-life assessments and muscle function. The failure puts access to the drug in jeopardy and is a significant setback for the treatment of the neurodegenerative disease.
Novartis announced positive results from the ASC4FIRST Phase III trial, showing that Scemblix (asciminib) demonstrated superior major molecular response (MMR) rates compared to standard-of-care tyrosine kinase inhibitors (TKIs) in newly diagnosed patients with chronic myeloid leukemia. The trial met both primary endpoints, with Scemblix showing favorable safety and tolerability profiles. These results suggest that Scemblix may offer a well-tolerated and highly efficacious treatment option for patients with chronic myeloid leukemia, addressing the unmet need for tolerable therapies that allow patients to balance treatment with their quality of life.
Pfizer's mRNA flu vaccine has met primary endpoints in a Phase III trial for the 18- to 64-year-old population, but the company has revised its timeline for launch, pushing it to "after 2024" instead of the previously anticipated 2024 launch. CEO Albert Bourla also mentioned that their next-generation mRNA flu and COVID-19 combination vaccine is expected to launch in 2025.
Omeros' drug candidate for immunoglobulin A nephropathy (IgAN) failed a Phase III study, causing the company's stock price to drop by nearly half. The late-stage failure is a setback for Omeros' pipeline-in-a-product plans for narsoplimab, and as a result, the ARTEMIS-IGAN study will be discontinued. The trial did not achieve statistical significance in reducing elevated protein levels in urine compared to the placebo.
A Phase III trial has found that MDMA-assisted therapy is effective in relieving symptoms of post-traumatic stress disorder (PTSD) when compared to standard therapy. The study involved over 100 participants with moderate to severe PTSD and showed that 86% of the MDMA group achieved a "clinically meaningful" improvement in symptoms compared to 69% of the control group. The nonprofit organization funding the research plans to seek formal approval from the FDA for MDMA-assisted therapy before the end of the year. If approved, this treatment could provide a valuable new option for individuals who haven't responded to existing medications or therapy.
San Francisco-based pharmaceutical company Vistagen experienced a surge in its stock price of over 1,000% after announcing positive results from a Phase III trial for its nasal spray in treating social anxiety disorder. The trial demonstrated statistically significant differences in subjective distress scores and clinician-assessed responders between the experimental drug and placebo.
In a Phase III trial comparing ViiV Healthcare's long-acting injectable Cabenuva with Gilead Sciences' daily pill Biktarvy for HIV treatment, the majority of patients preferred the injection over the pill, citing various physical and emotional benefits. Patients also reported improved adherence to the medication and emotional and psychological benefits. The study found that Cabenuva was "non-inferior" to Biktarvy in terms of efficacy and was preferred by 90% of patients after 12 months of treatment.
BridgeBio has announced positive results from its Phase III trial of acoramidis in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). The trial showed improvements in mortality, cardiovascular-related hospitalizations, a six-minute walk test, and a biomarker of the disease. Patients receiving the drug had an 81% survival rate at 30 months, compared to 74% on placebo, and the drug reduced hospitalization rates by 50%.
Moderna and Merck plan to launch a Phase III study this year for their personalized cancer vaccine in melanoma, and have revealed more details from a Phase IIb test that earlier this year renewed excitement about the use of vaccines in fighting tumors. AstraZeneca posted event-free survival data on Imfinzi’s use before and after surgery in patients with non-small cell lung cancer on Sunday, with its rival Merck months away from an FDA decision in the same indication.