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Clinical Trial News

Obsidian Solutions Group Awarded AFWERX Contract for Virtual Emergency Response Training

  • Obsidian Solutions Group received a $791,000 Direct-to-Phase II contract from AFWERX to develop virtual emergency response training.
  • The training program aims to enhance tactical team capabilities through advanced live, virtual, and constructive (LVC) exercises.
  • Obsidian's technology prototyping and demonstration were recognized as a viable solution for strengthening national defense.
  • The initiative supports the Department of the Air Force's efforts to streamline innovation and accelerate technology transition.

FDA Advisory Committee Skeptical of Stealth BioTherapeutics' Barth Syndrome Drug Application

  • Stealth BioTherapeutics faced scrutiny from the FDA's Cardiovascular and Renal Drugs Advisory Committee regarding its drug application for Barth syndrome.
  • Committee members questioned the feasibility of conducting a new randomized trial, citing challenges like potential functional unblinding.
  • Despite concerns, the committee acknowledged that inherent difficulties could compromise the integrity of a new study.
  • The advisory committee's skepticism raises uncertainty about the potential approval of Stealth BioTherapeutics' drug for Barth syndrome.

OKYO Pharma Doses First Patient in Phase 2 Trial of OK-101 for Neuropathic Corneal Pain

  • OKYO Pharma has dosed the first patient in its Phase 2 clinical trial evaluating OK-101 for the treatment of neuropathic corneal pain (NCP).
  • The Phase 2 trial is a randomized, double-masked, placebo-controlled study aiming to enroll 48 patients with confirmed NCP.
  • OK-101 is a non-opioid therapeutic candidate designed to alleviate pain associated with corneal nerve damage, addressing an unmet need.
  • The trial's primary endpoint is to measure pain relief using the Visual Analog Scale (VAS).

The Study Assessing the Safety and Efficacy of OK-101 Treatment in Subjects With Neuropathic Corneal Pain

NCT06637527RecruitingPhase 2
Okyo Pharma Ltd
Posted 10/15/2024

Alcon's AR-15512 Poised for FDA Approval for Dry Eye Treatment, Analysts Predict

  • Wells Fargo maintained a Buy rating on Alcon (ALC) with a $105 price target, driven by the potential FDA approval of AR-15512 for dry eye.
  • Phase 3 results showed statistically significant improvement in tear production, a primary endpoint, supporting likely FDA approval despite mixed results in symptom improvement.
  • KeyBanc also reiterated a Buy rating on Alcon's stock, setting a price target of $107, reinforcing positive market expectations for AR-15512.
  • Tolerability concerns exist due to mild irritation reported by some patients, but the overall outlook remains positive based on primary endpoint data and market comparisons.

Clinical Trial Reporting Rates on the Rise Globally, but Gaps Persist

  • Reporting rates for clinical trials are improving in the EU and the US, driven by stricter regulations and increased awareness.
  • Compliance varies significantly between countries, with Italy, the Netherlands, Spain, and France lagging in reporting results, especially for publicly funded trials.
  • Initiatives like the EU Trials Tracker and advocacy efforts are increasing transparency, but challenges remain in ensuring complete and accurate reporting.
  • Experts emphasize the ethical duty of scientists and funders to publish all trial information, regardless of outcome, for the benefit of patients and advancement of medical knowledge.

Adicet Bio's ADI-001 Receives FDA Clearance for Expanded Autoimmune Trial

• Adicet Bio's IND amendment for ADI-001 has been cleared by the FDA to include idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) in its Phase 1 autoimmune trial. • Patient enrollment for the IIM and SPS cohort is expected to begin in the first quarter of 2025, expanding the trial to six autoimmune indications. • The Phase 1 program will have four arms, each enrolling patients with lupus nephritis/SLE, SSc, AAV, or IIM/SPS, to assess safety, tolerability, and efficacy of ADI-001. • Initial clinical data from the Phase 1 study in multiple autoimmune diseases is anticipated in the first half of 2025, offering potential insights into ADI-001's therapeutic effects.

Guard Therapeutics Doses First European Patient in Phase 2b POINTER Study of RMC-035 for Kidney Protection

  • Guard Therapeutics has dosed the first European patient in its Phase 2b POINTER study, evaluating RMC-035 for kidney protection during open-heart surgery.
  • The POINTER study is a randomized, double-blind, placebo-controlled trial aiming to determine the optimal dosing regimen for RMC-035 and identify the target patient population.
  • The study will enroll approximately 160 patients, including those with chronic kidney disease, across 14 European clinics in Germany, the Czech Republic, and Spain.
  • RMC-035, a first-in-class drug, is being developed to mitigate kidney injury associated with open-heart surgery, potentially reducing the risk of long-term renal damage.

Novocure's Optune Device Receives Expanded FDA Approval for Lung Cancer Treatment

• The FDA has expanded the approval of Novocure’s Optune device for metastatic non-small cell lung cancer after initial chemotherapy failure. • The approval was based on the Phase 3 LUNAR trial, which demonstrated a 3.3-month increase in median overall survival with Optune. • Some experts find the LUNAR trial data challenging to interpret due to the limited use of immune checkpoint inhibitors in the study population. • FDA Commissioner Robert Califf highlights GLP-1 drugs' potential beyond weight loss, including cardiovascular health and addiction treatment.

Pain Relief Mechanisms Differ Between Sexes, Impacting Opioid Efficacy

  • A new study reveals that men and women utilize different biological systems for pain relief, with men relying on endogenous opioids and women using non-opioid pathways.
  • The research indicates that blocking the opioid system with naloxone inhibits meditation-based pain relief in men but enhances it in women, highlighting sex-specific responses.
  • Findings suggest that women's poorer response to opioid therapies may contribute to higher rates of dependence, as they may require higher doses for pain relief.
  • Tailoring pain treatment to an individual’s sex may improve patient outcomes and reduce reliance on opioids, especially for chronic pain management.

Chronic Low Back Pain and Meditation

NCT04034004CompletedEarly Phase 1
University of California, San Diego
Posted 1/1/2021

The Role of Opioidergic Systems in Breathing Based Analgesia

NCT03419858CompletedEarly Phase 1
University of California, San Diego
Posted 3/13/2017

Jaguar Health Launches Gelclair for Oral Mucositis in Cancer Patients

  • Jaguar Health has launched Gelclair, an FDA-approved prescription product, marking its entry into cancer supportive care.
  • Gelclair provides rapid, lasting pain relief for oral mucositis without stinging, addressing a significant need for cancer patients.
  • Oral mucositis affects up to 90% of head and neck cancer patients undergoing chemotherapy and radiotherapy, causing treatment interruptions.
  • The launch includes a dedicated sales team and digital marketing, targeting oncology professionals and patients to improve awareness.

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