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Clinical Trial News

Tempo Therapeutics Initiates Clinical Trial of TT101 for Tissue Repair in Skin Cancer Surgery

  • Tempo Therapeutics has dosed the first patients in a clinical trial of TT101, a regenerative medicine for tissue repair.
  • The trial evaluates TT101's safety and regenerative potential in surgical sites following skin cancer resection.
  • TT101 utilizes Microporous Annealed Particle (MAP) technology to promote tissue regrowth and minimize scarring.
  • The therapy addresses a significant unmet need for improved healing in complex surgical oncology cases.

Vesper Bio's VES001 Shows Promise in Phase I Trial for Frontotemporal Dementia

  • Vesper Bio's VES001 demonstrated a favorable safety and tolerability profile in a Phase I trial involving 78 healthy subjects.
  • The study confirmed that VES001 effectively distributes to plasma and the central nervous system after oral administration.
  • VES001 significantly engaged its target, increasing progranulin levels and showing potential for normalizing concentrations in patients.
  • Based on Phase I results, Vesper Bio plans to initiate a Phase IIa proof-of-concept study in Q4 2024.

FDA Approves Crexont (IPX203) for Parkinson's Disease with USF Researcher's Contribution

  • Crexont (IPX203), a new medication for Parkinson's disease, has been approved by the FDA, offering improved symptom control and longer-lasting relief compared to existing treatments.
  • Clinical trials, led by a USF researcher, demonstrated that Crexont allows patients to take fewer doses per day while maintaining symptom control for approximately 1.5 hours longer.
  • The drug's effectiveness is attributed to its slow-release formulation, which includes a mucoadhesive polymer for prolonged absorption in the lower intestine.
  • Crexont aims to reduce 'off time,' the period when Parkinson's symptoms return between doses, thereby enhancing the quality of life for individuals with Parkinson's.

Intrepid Valve Trial Shows Promise for Mitral Regurgitation Patients with Annular Calcification

  • A clinical trial using the Intrepid valve significantly improved the quality of life for a patient with mitral regurgitation (MR) and mitral annular calcification (MAC).
  • The Apollo trial offers a potential alternative for patients with MR who are not suitable candidates for open-heart surgery or edge-to-edge repair procedures.
  • The Intrepid valve allows for valve replacement without the need for decalcification, reducing surgical risks associated with mitral annular calcification.
  • University Hospitals Harrington Heart and Vascular Institute is the only center in Northeast Ohio participating in the Apollo trial, offering this innovative treatment option.

Postoperative Skeletal Muscle Loss Common After GI Cancer Surgery, Impacting Quality of Life

  • A prospective study reveals that 92% of gastrointestinal cancer patients experience skeletal muscle loss (SML) within three months post-surgery.
  • Researchers identified distinct patterns of SML, with advanced age, preoperative sarcopenia, inflammation, and advanced cancer stage as key predictors.
  • Moderate to severe SML is associated with significantly higher rates of postoperative complications and reduced quality of life.
  • The study emphasizes the importance of routine SMM assessment and early intervention to mitigate SML and improve patient outcomes.

Lilly's Once-Weekly Insulin Efsitora Shows Promise in Phase 3 Diabetes Trials

  • Eli Lilly's efsitora alfa, a once-weekly insulin, demonstrated non-inferior A1C reduction compared to daily insulin glargine in insulin-naïve adults with type 2 diabetes.
  • In adults with type 2 diabetes previously treated with basal insulin, efsitora showed non-inferior A1C reduction compared to daily insulin degludec.
  • A trial in type 1 diabetes showed non-inferior HbA1c reduction compared with daily insulin degludec, but higher rates of hypoglycemia were observed with efsitora.
  • Efsitora aims to simplify insulin therapy, potentially improving adherence and quality of life for individuals with type 1 and type 2 diabetes.

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

NCT04184622CompletedPhase 3
Eli Lilly and Company
Posted 12/4/2019

A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

NCT05275400CompletedPhase 3
Eli Lilly and Company
Posted 3/8/2022

A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

NCT05463744CompletedPhase 3
Eli Lilly and Company
Posted 8/12/2022

A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time

NCT05362058CompletedPhase 3
Eli Lilly and Company
Posted 6/3/2022

A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)

NCT05662332CompletedPhase 3
Eli Lilly and Company
Posted 1/14/2023

FDA Asked to Scrutinize US Pharma's Clinical Trials with PLA Affiliates

  • A bipartisan group of U.S. representatives has requested the FDA to provide information on clinical trials conducted by major U.S. biopharmaceutical companies in collaboration with entities affiliated with China's People's Liberation Army (PLA).
  • The representatives are concerned about potential technology transfer and intellectual property risks associated with these collaborations, especially given the PLA's Academy of Military Medical Sciences being on the Commerce Department's Entity List.
  • The FDA is asked to disclose how many PLA-affiliated facilities it has reviewed for clinical trial work and whether it has ever notified U.S. companies about conducting studies with the PLA or in regions with ethical concerns.
  • The request follows previous instances where the FDA declined oncology treatment approvals based solely on clinical trial data from China, suggesting a need for similar scrutiny in cases involving PLA collaboration.

Stifel Initiates Coverage on ORIC Pharmaceuticals with Buy Rating and $20 Target

Stifel has initiated coverage on ORIC Pharmaceuticals with a Buy rating and a $20 price target, highlighting the company's potential in prostate cancer treatments, especially its ORIC-944 product expected to enter phase 3 trials in 2025. ORIC Pharmaceuticals is noted for its innovative approach to treating metastatic castration-resistant prostate cancer, with ORIC-944 utilizing PRC2 inhibition in combination with androgen receptor pathway inhibitors.

FDA Approves Updated COVID-19 Vaccines for Fall and Winter

  • The FDA has approved updated COVID-19 vaccines from Pfizer and Moderna, designed to target newer variants like KP.2, for the upcoming fall and winter seasons.
  • These updated vaccines utilize mRNA technology to stimulate the body's immune response, offering a potentially more effective defense against current COVID-19 strains.
  • The CDC recommends that all Americans aged six months and older receive the updated COVID-19 vaccine to protect against an anticipated surge in cases during the fall and winter.
  • Local health departments will receive limited vaccine supplies for uninsured and underinsured patients, while insured individuals are advised to check with their local pharmacies.

AI Predicts Patient Dropout in Clinical Trials, Improving Adherence

  • AI-powered platforms are being utilized to predict patient dropout and non-adherence in clinical trials, helping sponsors avoid wasted resources.
  • These AI tools analyze various factors to identify participants at high risk of dropping out or not adhering to medication regimens.
  • Schizophrenia and obesity drug trials have successfully employed AI technology to improve patient engagement and reduce dropout rates.
  • AI-driven platforms use computer vision, synchronous chat, and predictive analytics to track participation and provide timely interventions.

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