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Phase Iii Trial

All articles tagged with #phase iii trial

health22 days ago•17 min saved

LSD-Based DT120 Delivers Promising Depression Relief in Phase III Trial

Definium Therapeutics reports that a single 100‑microgram dose of its LSD‑based DT120 significantly reduced major depressive disorder symptoms versus placebo in a 149‑participant Phase III trial across 20 sites, with a week‑6 average 8.1‑point greater drop on a standard depression scale, about 35% of DT120 users achieving a 50%+ improvement (vs 7% placebo), and 12% in remission (vs 3%), with effects persisting through 12 weeks. The company plans FDA expedited review pending results from a second Phase III trial (Ascend) and continued development of DT120 for anxiety disorders, signaling potential for rapid, durable relief from a single treatment if approved.

via Gizmodo|

#depression #fda #health

health3 months ago•9 min saved

Oral PCSK9 Pill Cuts LDL Cholesterol by Up to 60% in Phase 3 Trial

A phase 3 trial of the daily oral PCSK9 inhibitor enlicitide showed LDL cholesterol falls by about 60% in 2,909 patients with atherosclerosis or high cardiovascular risk, many already on statins. The pill also reduced non-HDL cholesterol, apolipoprotein B, and lipoprotein(a), with effects lasting one year. If FDA approves, enlicitide could offer an oral alternative to injectable PCSK9 therapies and improve adherence, though a separate study is needed to confirm whether these LDL reductions translate into fewer heart attacks and strokes. The trial was Merck-funded and ongoing work aims to determine cardiovascular event outcomes.

via SciTechDaily|

#cholesterol #enlicitide #health

health-and-medicine2 years ago•0 min saved

"Final Stage Trial of Gates-Backed TB Vaccine Underway in South Africa"

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.

via Endpoints News|

#bill-and-melinda-gates-foundation #health-and-medicine #phase-iii-trial

health-pharmaceuticals2 years ago•0 min saved

Amylyx's ALS Drug Relyvrio Fails Phase 3 Trial, Potential Market Withdrawal

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.

via Endpoints News|

#als #amylyx #drug-withdrawal

healthcare2 years ago•11 min saved

"Scemblix® Outperforms Standard Treatment in Phase III Trial for Chronic Myeloid Leukemia"

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.

via Novartis|

#chronic-myeloid-leukemia #healthcare #novartis

health2 years ago•0 min saved

Pfizer and Moderna's mRNA flu vaccines show promise in trials, raising hopes for dual COVID-19 protection

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.

via Endpoints News|

#covid-19-combination-vaccine #health #launch-timeline

healthcare2 years ago•0 min saved

Omeros Abandons Kidney Disease Therapy After Failed Trial

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.

via Endpoints News|

#healthcare #immunoglobulin-a-nephropathy #kidney-disease

health2 years ago•3 min saved

"Breakthrough Study Shows MDMA Therapy's Promise for PTSD Treatment"

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.

via Gizmodo|

#fda-approval #health #mdma-assisted-therapy

pharmaceuticals2 years ago•0 min saved

Vistagen's Social Anxiety Nasal Spray Trial Sends Stock Price Soaring

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.

via Endpoints News|

#nasal-spray #pharmaceuticals #phase-iii-trial

healthcare3 years ago•0 min saved

Cabenuva Outperforms Biktarvy in PhIII Trial with 90% Patient Preference

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.

via Endpoints News|

#biktarvy #cabenuva #healthcare

healthcare3 years ago•0 min saved

BridgeBio's ATTR-CM Trial Demonstrates Significant Mortality and Hospitalization Reduction

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%.

via Endpoints News|

#acoramidis #attr-cm #bridgebio

healthcare3 years ago•7 min saved

Moderna and Merck's mRNA cancer vaccine shows promise in reducing risk of melanoma relapse.

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.

via Endpoints News|

#cancer-vaccine #healthcare #lung-cancer