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Clinical Trial News

Bonafide Health Launches Thermella, a Hormone-Free NK3R Antagonist for Menopause

  • Bonafide Health has launched Thermella, a hormone-free, prescription-free NK3R antagonist, to relieve hot flashes and night sweats associated with menopause.
  • Clinical trials showed that over 90% of participants experienced improvement in moderate to severe hot flashes within 12 weeks of using Thermella.
  • Thermella is formulated with curcumin extract, green tea extract, and spirulina extract, targeting the neurokinin B (NKB) pathway to rebalance the body's thermoregulatory center.
  • Studies suggest a favorable safety profile, with no serious adverse events reported and no estrogenic effects observed on breast cancer cell lines.

Herbal Nutraceutical Supplementation on Vasomotor Symptoms in Menopausal Women

NCT05813067CompletedNot Applicable
Bonafide Health
Posted 12/27/2022

Kazia Therapeutics' EVT801 Shows Promise in Ovarian Cancer Trial

  • Kazia Therapeutics presented Phase 1 data for EVT801, a VEGFR3 inhibitor, at the Ovarian Cancer Research Symposium, showcasing its potential in treating advanced ovarian cancer.
  • The Phase 1 trial of EVT801 met its primary objectives, establishing a maximum tolerated dose of 500mg BID and identifying 400mg BID as the recommended Phase 2 dose.
  • In heavily pretreated ovarian cancer patients, 46% achieved stable disease for at least three cycles, with one patient experiencing a partial response after two cycles of EVT801 therapy.
  • EVT801 was well-tolerated across all doses, with most toxicities being mild to moderate and transient, suggesting a favorable safety profile for further clinical development.

Vistagen Initiates Phase 3 Trial of Fasedienol for Acute Social Anxiety Disorder Treatment

  • Vistagen has commenced the PALISADE-4 Phase 3 trial to assess fasedienol nasal spray for acute treatment of social anxiety disorder (SAD).
  • The trial will evaluate fasedienol's efficacy, safety, and tolerability in adults with SAD during induced anxiety in a clinical setting.
  • Fasedienol, a neuroactive pherine, offers a novel non-systemic approach, potentially transforming acute SAD treatment for over 30 million Americans.
  • The FDA has granted Fast Track designation for fasedienol, highlighting the unmet need for acute SAD treatments.

Immusoft's Engineered B Cell Therapy Shows Promise in Phase 1 MPS I Trial

  • Immusoft announced positive Phase 1 results for ISP-001, an engineered B cell therapy, in a patient with mucopolysaccharidosis type I (MPS I).
  • The trial, supported by an $8 million CIRM award, demonstrated pharmacodynamic and functional improvements nine months post-dosing with a single ISP-001 administration.
  • The therapy was well-tolerated, with no adverse events reported as of September 19, 2024, and did not require preconditioning regimens.
  • Initial data, to be presented on October 14, 2024, indicate potential improvements in quality of life, activities of daily living, and pain reduction associated with MPS I.

ISP-001: Sleeping Beauty Transposon-Engineered B Cells for MPS I

NCT05682144RecruitingPhase 1
Immusoft of CA, Inc.
Posted 4/12/2023

Rivus Pharmaceuticals' HU6 Shows Muscle-Sparing Weight Loss in HFpEF Trial

• Rivus Pharmaceuticals' HU6 demonstrated statistically significant reductions in fat mass and visceral fat in obese patients with heart failure with preserved ejection fraction (HFpEF). • The Phase IIa HuMAIN trial showed that HU6 preserved lean body mass, a crucial benefit for HFpEF patients where muscle loss is linked to increased mortality. • HU6 also showed promise in improving systolic and diastolic blood pressure and markers of cardiovascular disease, according to trial data presented at HFSA 2024. • Rivus plans to engage with health authorities in 2025 to discuss a Phase 3 study of HU6 in obesity-related HFpEF, aiming to address the unmet need for targeted therapies.

Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

NCT05284617CompletedPhase 2
Rivus Pharmaceuticals, Inc.
Posted 10/30/2022

Theriva Biologics Completes Enrollment in Phase 2b VIRAGE Trial of VCN-01 for Metastatic Pancreatic Cancer

  • Theriva Biologics has achieved target enrollment of 92 patients in its Phase 2b VIRAGE trial for metastatic pancreatic ductal adenocarcinoma (PDAC).
  • The VIRAGE trial evaluates VCN-01, an oncolytic adenovirus, in combination with gemcitabine/nab-paclitaxel as a first-line therapy for PDAC.
  • VCN-01 has received Orphan Drug and Fast Track designations from the FDA for the treatment of PDAC, highlighting its potential impact.
  • The company is planning regulatory discussions to determine the next steps for VCN-01's clinical development, including a possible interim data analysis.

Study to evaluate the impact of VCN-01 on the overall survival of patients with advanced pancreatic cancer treated with standard therapy.

2024-511290-30-00CompletedPhase 2
Theriva Biologics S.L., Theriva Biologics S.L.

Oryzon's Vafidemstat Receives FDA Support for Phase III Trial in Borderline Personality Disorder

  • Oryzon Genomics has received positive feedback from the FDA regarding its Phase II meeting for vafidemstat in Borderline Personality Disorder (BPD).
  • The FDA supports the initiation of a Phase III trial, acknowledging agitation-aggression in BPD as a potential therapeutic indication.
  • Oryzon may use the STAXI-2 Trait anger scale as a primary efficacy endpoint for the PORTICO-2 trial, pending further validation.
  • Vafidemstat demonstrated a statistically significant reduction in agitation and aggression in the Phase IIb PORTICO study, showing promise for BPD treatment.

Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population

NCT04932291CompletedPhase 2
Oryzon Genomics S.A.
Posted 3/26/2021

Assembly Bio's ABI-5366 Shows Promise for Recurrent Genital Herpes Treatment

  • Assembly Biosciences reports positive Phase 1a results for ABI-5366, an HSV helicase-primase inhibitor, showing a favorable safety profile.
  • The drug exhibits an approximate 20-day half-life, supporting potential once-weekly or once-monthly oral dosing regimens.
  • Phase 1b screening is underway to assess ABI-5366's efficacy in participants with recurrent genital herpes, with interim results expected in H1 2025.

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes

NCT06385327RecruitingPhase 1
Assembly Biosciences
Posted 5/30/2024

Carrick Therapeutics Initiates Phase 1 Trial of Novel CDK12/13 Inhibitor CT7439 in Advanced Solid Tumors

  • Carrick Therapeutics has dosed the first patient in a Phase 1 clinical trial of CT7439, a novel CDK12/13 inhibitor and Cyclin-K glue-degrader.
  • The Phase 1 trial will assess the safety, pharmacokinetics, and early proof of principle of CT7439 in patients with advanced solid tumors.
  • CT7439's dual mechanism of action targets DNA repair at the transcriptional level, potentially synergizing with PARP inhibitors in various cancers.
  • This trial marks the advancement of Carrick Therapeutics' second therapeutic into clinical development for aggressive and resistant cancers.

A Modular Phase 1/2 Study with CT7439 in Participants with Solid Malignancies

NCT06600789RecruitingPhase 1
Carrick Therapeutics Limited
Posted 8/16/2024

Ipsen's Kayfanda (Odevixibat) Receives EU Approval for Cholestatic Pruritus in Alagille Syndrome

  • The European Commission has approved Kayfanda (odevixibat) for treating cholestatic pruritus in Alagille Syndrome (ALGS) patients aged six months and older.
  • Kayfanda's approval is based on the ASSERT Phase III trial, which demonstrated significant improvements in scratching severity and serum bile acid concentration.
  • Odevixibat, a once-daily non-systemic ileal bile acid transport (IBAT) inhibitor, reduces serum bile acids by blocking the IBAT protein.
  • This approval expands Ipsen’s portfolio in rare cholestatic liver diseases, offering a new treatment option for the ALGS community in the EU.

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