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Clinical Trial News

Cidara Therapeutics Cuts Workforce to Prioritize CD388 Influenza Prevention Program

  • Cidara Therapeutics is reducing its workforce by 30%, impacting 20 positions, to focus on the clinical development of CD388, an influenza prevention therapy.
  • The company plans to initiate a Phase IIb trial of CD388 for influenza A and B prevention in the Northern Hemisphere's upcoming flu season.
  • Cidara reacquired rights to CD388 from Johnson & Johnson for $85 million and is now responsible for its development and marketing, with potential milestone payments to J&J.
  • Despite promising Phase IIa data showing a numerical decrease in influenza virus replication, the reduction was not statistically significant.

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

NCT05285137CompletedPhase 1
Cidara Therapeutics Inc.
Posted 3/14/2022

Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

NCT05619536CompletedPhase 1
Cidara Therapeutics Inc.
Posted 10/18/2022

The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults

NCT05523089CompletedPhase 2
Cidara Therapeutics Inc.
Posted 9/9/2022

Moberg Pharma's MOB-015 Phase 3 Trial Shows Lower Than Expected Clinical Cure Rate

  • Moberg Pharma reports that a subset of patients in their North American Phase 3 study of MOB-015 achieved clinical cure for nail fungus at a rate lower than anticipated.
  • Cipher Pharmaceuticals, which holds Canadian marketing rights to MOB-015, acknowledges the update from Moberg Pharma regarding the clinical trial results.
  • Cipher Pharmaceuticals emphasizes that the outcome of the MOB-015 trial does not currently impact the company's sales and earnings profile.
  • Cipher Pharmaceuticals remains focused on the integration of the Natroba™ business and other potential growth opportunities.

AZD8205 Shows Promise in Heavily Pretreated Solid Tumors: ESMO 2024

  • AZD8205, a novel antibody-drug conjugate, demonstrates a manageable safety profile in heavily pretreated patients with advanced or metastatic solid tumors.
  • The Phase I/II trial of AZD8205 showed promising clinical activity, particularly in gynecologic tumors and breast cancer, with partial responses observed.
  • Common grade 3 or higher adverse effects included neutropenia, anemia, and decreased white blood cell count, manageable with dose adjustments.
  • Phase II expansion cohorts are underway to further evaluate AZD8205 in ovarian, breast, endometrial, and biliary tract cancers.

A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies

NCT05123482RecruitingPhase 1
AstraZeneca
Posted 10/18/2021

Inflammatix Secures $57 Million to Advance TriVerity Sepsis Test

• Inflammatix has raised $57 million to support regulatory filing and commercialization of its TriVerity rapid blood test for acute infection and sepsis. • The TriVerity system measures gene expression levels in blood related to immune response, providing results in about 30 minutes using machine learning. • The FDA granted breakthrough device designation to TriVerity, intended to expedite clearance and Medicare coverage; regulatory submission is already underway. • Inflammatix plans to expand its commercial team and conduct clinical studies while awaiting FDA clearance for the TriVerity test in the coming months.

FDA Approves Dupixent as First Biologic for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

• The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). • This approval marks the first time a biologic is specifically indicated for adolescent CRSwNP, offering an alternative to standard treatments like steroids and surgery. • The decision was supported by data from the SINUS-24 and SINUS-52 trials, which demonstrated significant improvements in nasal congestion, polyp size, and sense of smell. • Dupixent, a fully human monoclonal antibody, inhibits the IL-4 and IL-13 pathways, addressing type 2 inflammation, a key driver in CRSwNP, and is not an immunosuppressant.

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

NCT02912468CompletedPhase 3
Sanofi
Posted 12/5/2016

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

NCT02898454CompletedPhase 3
Sanofi
Posted 11/28/2016

Engineered Toxoplasma Gondii Delivers Therapeutic Proteins to Mouse Brain

  • Researchers engineered Toxoplasma gondii to deliver large proteins across the blood-brain barrier in mice, overcoming a major obstacle in brain-targeted drug delivery.
  • The engineered parasite efficiently delivered various therapeutic proteins to neurons and could simultaneously deliver multiple proteins, demonstrating versatility.
  • Delivery of MeCP2, a target in Rett syndrome, to brain organoids showed the protein bound to methylated DNA and altered gene expression, indicating functionality.
  • In mice, the engineered T. gondii distributed MeCP2 throughout the brain, with highest levels in the cortex, suggesting a potential therapeutic approach.

Pemivibart Guidelines Updated for COVID-19 Preexposure Prophylaxis in Immunocompromised Patients

  • The FDA authorized pemivibart for preexposure prophylaxis of COVID-19 in moderately to severely immunocompromised individuals aged 12 years and older.
  • IDSA updated its COVID-19 treatment guidelines, suggesting clinicians use pemivibart prophylactically when circulating variants are susceptible.
  • Pemivibart's efficacy is inferred via immunobridging, comparing it to adintrevimab, which showed reduced symptomatic COVID-19 risk in trials.
  • Emerging data suggest potential reduced susceptibility of pemivibart to newer variants, necessitating ongoing monitoring and research efforts.

A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2

NCT06039449CompletedPhase 3
Invivyd, Inc.
Posted 9/8/2023

Lenvatinib and Pembrolizumab Combination Shows Promise in Advanced Thymic Epithelial Tumors

  • The combination of lenvatinib and pembrolizumab demonstrated a promising 5-month progression-free survival (PFS) rate of nearly 90% in patients with platinum-refractory advanced thymic epithelial tumors.
  • Median PFS reached 14.9 months, with a 12-month PFS rate of 56%, indicating a potential new standard treatment for advanced B3-thymoma and thymic carcinoma.
  • The combination showed an objective response rate of 23.3% and manageable safety profile, though close monitoring for adverse events is crucial for optimal patient management.

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

NCT04710628Active, Not RecruitingPhase 2
MedSIR
Posted 9/21/2021

Comprehensive Digital System Reduces Symptom Burden in Cancer Patients Undergoing Chemotherapy

  • A randomized clinical trial evaluated the efficacy of a multicomponent digital intervention, Symptom Care at Home (SCH), in reducing symptom burden among cancer patients undergoing chemotherapy.
  • The complete SCH intervention, which includes automated self-management coaching and nurse practitioner (NP) follow-up with decision support, significantly reduced symptom burden compared to individual components alone.
  • NP follow-up was superior to self-management coaching, but there was no significant difference between activity tracker groups or between the two NP groups.
  • The study suggests that a comprehensive, multicomponent digital approach to cancer symptom management offers optimal symptom burden reduction and improved symptom control during chemotherapy.

SymptomCare@Home: Deconstructing an Effective Symptom Management Intervention

NCT02779725CompletedNot Applicable
University of Utah
Posted 8/7/2017

Fixed-Duration Venetoclax Regimens Offer CLL Patients a Balanced Approach

  • Fixed-duration treatments in CLL offer a defined treatment period, contrasting with continuous therapies that require ongoing administration until disease progression or unacceptable toxicity.
  • Venetoclax-based regimens, such as venetoclax plus obinutuzumab for 12 cycles in the frontline setting, provide a time-limited treatment option.
  • In the relapsed/refractory setting, venetoclax combined with rituximab is approved for 24 cycles, offering another fixed-duration approach for CLL management.

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