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Synbiotic Supplementation to Prevent Preterm Birth: A Multi-Center Trial

  • A multi-center, randomized, placebo-controlled trial is underway to investigate the efficacy of synbiotic supplementation in preventing spontaneous preterm birth (sPTB).
  • Pregnant women at risk for sPTB between 80/7 and 106/7 weeks of gestation will receive either a synbiotic containing eight Lactobacillus strains or a placebo daily until delivery.
  • The primary outcome is gestational age at delivery, with secondary outcomes including PTB rates, PPROM rates, vaginal microbiome analysis, and neonatal outcomes.
  • The trial aims to recruit 402 participants across seven Belgian teaching hospitals over approximately 36 months to determine if synbiotics can prolong pregnancy and improve neonatal health.

Ascletis' ASC30 Enters Phase I Trials as Novel Oral and Injectable Obesity Treatment

  • Ascletis has initiated two Phase I clinical trials in the U.S. for ASC30, a small molecule GLP-1R agonist, offering both once-monthly subcutaneous injection and once-daily oral tablet options for obesity treatment.
  • Preclinical data indicates ASC30 is two- to threefold more potent than orforglipron in vitro and demonstrates superior insulin secretion in non-human primates.
  • Animal studies show that ASC30 sustains weight loss with both monthly injections and daily oral doses, supporting its potential for convenient administration in humans.
  • Topline data from the Phase I trials are expected in the first quarter of 2025, potentially positioning ASC30 as a first-in-class and best-in-class GLP-1R agonist.

Ferrer's FNP-223 Enters Phase II Trial for Progressive Supranuclear Palsy

  • Ferrer has dosed the first participant in the Phase II PROSPER trial, evaluating FNP-223 for Progressive Supranuclear Palsy (PSP).
  • The PROSPER trial is a randomized, double-blind, placebo-controlled study with a 52-week treatment period and a 4-week follow-up.
  • FNP-223 aims to slow PSP progression by preventing abnormal accumulation of tau proteins in neurons, based on preclinical data.
  • The PROSPER trial will enroll up to 220 participants across the US, UK, and EU, with recruitment ongoing in the United States.

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)

NCT06355531RecruitingPhase 2
Ferrer Internacional S.A.
Posted 7/23/2024

Cardiovascular Device Recalls Linked to Insufficient Premarket Testing

  • A new analysis reveals that many recalled cardiovascular devices lacked rigorous premarket clinical testing, raising concerns about patient safety.
  • The FDA's 510(k) pathway, used for moderate-risk devices, was associated with a high proportion of Class I recalls, the most serious type.
  • Postmarket surveillance for these devices was also found to be inadequate, with many devices being recalled before postapproval studies were completed.
  • Experts suggest strengthening evidence requirements for device approval and enhancing postmarket monitoring to ensure device safety and efficacy.

Kisqali and Itovebi Secure FDA Approval for Advanced Breast Cancer Treatment

  • Ribociclib (Kisqali) gains FDA approval in combination with aromatase inhibitors for adjuvant treatment of HR+/HER2- early breast cancer, reducing recurrence risk.
  • Inavolisib (Itovebi) receives FDA approval when combined with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
  • The approvals offer new treatment options for a broader range of breast cancer patients, addressing unmet needs and improving care approaches.

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 7/12/2017

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

NCT05646862Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 6/7/2023

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

NCT05894239RecruitingPhase 3
Hoffmann-La Roche
Posted 9/8/2023

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

AstraZeneca's Imfinzi and Imjudo Combo Shows Sustained Survival Benefit in Liver Cancer

  • The STRIDE regimen (Imfinzi plus Imjudo) demonstrated a 24% reduction in the risk of death compared to sorafenib in unresectable hepatocellular carcinoma (HCC).
  • Approximately 19.6% of patients treated with the STRIDE regimen were alive at five years, compared to 9.4% treated with sorafenib.
  • The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, with no new safety signals observed.
  • These results reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease.

Pazopanib and Bevacizumab Combination Doubles Survival in Advanced Kidney Cancer

  • A phase 2 clinical trial demonstrated that combining pazopanib and bevacizumab significantly extends progression-free survival in patients with advanced kidney cancer.
  • The combination therapy resulted in a median progression-free survival of 23 months, more than double the 11 months seen with pazopanib alone in previous trials.
  • The treatment regimen showed a favorable safety profile compared to immunotherapy combinations, making it a promising option for patients in the favorable risk group.
  • The study's encouraging results suggest that alternating pazopanib with bevacizumab could be a beneficial treatment strategy for renal cell carcinoma.

Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer

NCT01684397Active, Not RecruitingPhase 1
Roswell Park Cancer Institute
Posted 11/21/2012

Recent Pipeline Activity: Key Approvals and Phase III Readouts in Pharmaceuticals

  • Recent pharmaceutical pipeline activity reveals four new drug approvals, offering potential advancements in treatment options for various conditions.
  • Multiple Phase III clinical trials have recently reported results, shaping the near-term outlook for several investigational therapies.
  • These developments underscore the dynamic nature of pharmaceutical research and development, highlighting both successes and ongoing efforts to address unmet medical needs.

MinervaX and Wacker Biotech Collaborate to Advance Group B Streptococcus Vaccine Production

  • MinervaX and Wacker Biotech collaborate to scale up manufacturing of MinervaX's novel protein-only vaccine against Group B Streptococcus (GBS) in preparation for Phase III trials.
  • Wacker Biotech will handle technology transfer, process validation, and commercial manufacturing of the vaccine's active protein ingredients at its Amsterdam facility.
  • The GBS vaccine targets maternal immunization to prevent adverse pregnancy outcomes and life-threatening infections in newborns, addressing a critical unmet medical need.
  • MinervaX's vaccine has demonstrated an acceptable safety profile and high immunogenicity in Phase II trials, showing potential for broad protection against GBS.

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV

NCT04596878CompletedPhase 2
Minervax ApS
Posted 11/19/2020

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

NCT05782179CompletedPhase 1
Minervax ApS
Posted 3/1/2023

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

NCT05154578CompletedPhase 2
Minervax ApS
Posted 2/17/2022

Expert Highlights Critical Role of Early Diagnosis and Targeted Therapy in BPDCN Management

  • Dr. James Foran of Mayo Clinic emphasizes that BPDCN, often misdiagnosed as other leukemias, requires precise identification of CD123, CD4, and CD56 markers for accurate diagnosis.
  • The FDA-approved CD123-targeted immunotoxin tagraxofusp (Elzonris) has shown promising outcomes in BPDCN treatment, marking a significant advancement in targeted therapy.
  • Early intervention and allogeneic transplantation are crucial for achieving long-term remission and potential cure in BPDCN patients, according to expert insights.

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