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Clinical Trial News

Lipella Pharmaceuticals' LP-310 Shows Promise in Phase 2a Trial for Oral Lichen Planus

  • Lipella Pharmaceuticals completes the first cohort dosing in its Phase 2a trial of LP-310 for Oral Lichen Planus (OLP).
  • Initial results from the 0.25 mg dose cohort show promising tolerability and minimal systemic exposure of tacrolimus.
  • The trial advances to the next stage, evaluating a higher dose of 0.5 mg of LP-310, with top-line data expected by year-end.
  • LP-310 aims to address the unmet need for effective, well-tolerated treatments for OLP, impacting approximately 6 million Americans.

Evaluating LP-10 in Subjects With OLP

NCT06233591Active, Not RecruitingPhase 2
Lipella Pharmaceuticals, Inc.
Posted 7/1/2024

FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer

• The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC). • Approval was based on a 52% objective response rate and a 14.9-month median duration of response in the HERIZON-BTC-01 clinical trial. • Ziihera is the first dual HER2-targeted bispecific antibody approved for HER2-positive BTC, offering a chemotherapy-free treatment option. • Zymeworks is eligible for up to $500M in regulatory milestones and tiered royalties from Jazz Pharmaceuticals following the approval.

Neuralink Receives Approval to Begin Brain Chip Trials in Canada

  • Neuralink has received approval from Health Canada to launch its first clinical trial in Canada, marking the first trial site outside of the U.S.
  • The trial will be conducted at Toronto Western Hospital, focusing on patients with quadriplegia due to ALS or spinal cord injury.
  • The CAN-PRIME study will assess the functionality and safety of Neuralink's fully implanted wireless brain-computer interface (BCI) device.
  • Neuralink is recruiting patients who can operate a computer or smartphone using only their thoughts, without physical movement or cables.

Tirzepatide (Zepbound) Shows Promise in Reducing Heart Failure Deaths in Obese Patients

  • Tirzepatide (Zepbound) significantly reduced the risk of death or worsening heart failure in obese patients with heart failure with preserved ejection fraction.
  • Patients taking tirzepatide experienced an average weight loss of 11.6% and showed improvements in exercise capacity and reduced inflammation markers.
  • MRI scans revealed that tirzepatide led to beneficial reductions in heart weight and surrounding fat, suggesting a reversal of obesity-related heart abnormalities.
  • The clinical trial demonstrated benefits beyond weight loss, indicating tirzepatide's potential as an important treatment for obesity-related heart failure.

FDA Approves Bimzelx (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa

  • The FDA has approved Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults, offering a new treatment option.
  • Bimzelx is the first treatment of its kind, selectively inhibiting both IL-17A and IL-17F, providing a novel approach to managing this inflammatory skin condition.
  • Clinical trials demonstrated that Bimzelx achieved significant and sustained clinical responses in patients with HS over a 48-week period.
  • Data presented at ACR Convergence 2024 highlighted Bimzelx's sustained efficacy in treating psoriatic arthritis and axial spondyloarthritis over two years.

Wearable Skin Patch Offers Continuous Blood Pressure Monitoring

  • Researchers have developed a wearable ultrasound patch for continuous blood pressure monitoring, offering a potential alternative to traditional cuff measurements.
  • The patch uses ultrasound waves to track changes in blood vessel diameter, converting these changes into blood pressure values, and has shown accuracy comparable to invasive methods.
  • Testing across various conditions, including daily activities and clinical settings, demonstrated the patch's reliability in providing accurate blood pressure readings.
  • The development team plans to refine the device and conduct larger clinical trials to further validate its efficacy and potential for widespread use.

Phase I/II Trial of Lu177-PentixaTher Initiated for Relapsed/Refractory AML and ALL

  • Pentixapharm's Phase I/II trial PENTILULA is evaluating Lu177-PentixaTher in relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
  • The open-label, multicenter trial aims to determine the maximum tolerated dose (MTD) and assess efficacy parameters like overall response rate (ORR) and complete remission (CR).
  • Lu177-PentixaTher targets the CXCR4 receptor, offering a novel radiopharmaceutical approach for hematologic malignancies with high unmet medical needs.
  • The trial, funded by the French Ministry of Health, enrolls up to 21 patients over 24 months, with a total study duration of 36 months.

Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.

NCT06356922RecruitingPhase 1
Nantes University Hospital
Posted 10/22/2024

Embolization Plus Surgery Reduces Repeat Operations for Subdural Hematomas

  • A new study reveals that combining standard hematoma surgery with embolization of the middle meningeal artery significantly reduces the need for repeat surgeries in patients with subdural hematomas.
  • The trial, involving 400 patients, showed that the combination approach, using Medtronic's Onyx, decreased repeat surgeries within three months from 11.3% to 4%.
  • Embolization, a minimally invasive procedure, blocks the middle meningeal artery, preventing hematoma recurrence, particularly beneficial for older patients on blood thinners.
  • Researchers suggest this new approach could transform the treatment of subdural hematomas, reducing the need for multiple surgeries and improving patient outcomes.

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