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Clinical Trial News

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

DBV Technologies has announced positive topline results from its Phase 3 EPITOPE trial, evaluating the safety and efficacy of Viaskin Peanut in treating peanut-allergic toddlers aged 1 to 3 years. The trial met its primary endpoint, showing a significant treatment effect with 67.0% of subjects in the Viaskin Peanut arm meeting response criteria at 12 months, compared to 33.5% in the placebo arm.

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

NCT03211247CompletedPhase 3
DBV Technologies
Posted 7/31/2017

Dostarlimab Achieves 100% Complete Response Rate in Rectal Cancer Trial with Mismatch Repair Deficiency

  • A phase 2 clinical trial at Memorial Sloan Kettering Cancer Center found that dostarlimab achieved complete cancer remission in all 14 patients with locally advanced rectal cancer harboring mismatch repair deficiency mutations.
  • Patients received dostarlimab every three weeks for six months, avoiding the need for standard chemotherapy, radiation, and surgery while maintaining normal body functions and quality of life.
  • The immunotherapy drug targets a rare genetic subtype affecting 5-10% of rectal cancer patients, with follow-up ranging from six to 25 months showing no cancer recurrence.
  • Researchers emphasize the need for larger studies to confirm these unprecedented results and determine long-term cure rates in this specific patient population.

FDA Approves Fylnetra, Fifth Biosimilar of Neulasta, for Febrile Neutropenia

  • The FDA has approved Fylnetra (pegfilgrastim-pbbk), a biosimilar referencing Neulasta, developed by Amneal Pharmaceuticals and Kashiv Biosciences.
  • Fylnetra is indicated to treat or prevent febrile neutropenia in cancer patients undergoing chemotherapy, addressing a critical need in supportive cancer care.
  • This approval marks the fifth pegfilgrastim biosimilar in the US, the third biosimilar approval for Amneal, and the second drug approval for Kashiv Biosciences.
  • Amneal Pharmaceuticals anticipates launching Fylnetra, along with Releuko and Alymsys, in the latter half of 2022, expanding access to these vital medications.

Eagle Pharmaceuticals Submits NDA for Landiolol, Ultra-Short-Acting Beta Blocker for Critical Care Tachycardia

Drug Approval
  • Eagle Pharmaceuticals announced that AOP Orphan Pharmaceuticals submitted a new drug application to the FDA for landiolol, seeking approval for short-term reduction of ventricular rate in patients with supraventricular tachycardia.
  • Landiolol is an ultra-short-acting, cardio-selective beta-1 adrenergic blocker with a β1:β2 ratio of 255:1, making it the most cardioselective beta blocker available.
  • The drug is already commercially available in Japan and several European markets, with multiple clinical studies demonstrating its safety and efficacy for rapid short-term control of tachyarrhythmias.
  • If approved, Eagle expects five years of new chemical entity exclusivity and anticipates approval by mid-year 2023 based on FDA feedback from a Type C meeting.

Risankizumab Shows Efficacy in Crohn's Disease Induction Therapy

  • Risankizumab demonstrated significant clinical remission in patients with moderately to severely active Crohn's disease in the ADVANCE and MOTIVATE trials.
  • Both 600mg and 1200mg doses of risankizumab met all co-primary endpoints, including clinical remission and endoscopic response, at week 12.
  • The trials included patients who had previously shown intolerance or inadequate response to biologics or conventional therapies.
  • Risankizumab was generally well-tolerated, with a similar incidence of adverse events across treatment groups.

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

NCT03104413CompletedPhase 3
AbbVie
Posted 12/18/2017

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

NCT03105128CompletedPhase 3
AbbVie
Posted 5/10/2017

Uliledlimab Shows Promise in Advanced NSCLC with High CD73 Expression

  • Uliledlimab, a CD73 antibody, demonstrates a favorable safety profile both as a monotherapy and in combination with toripalimab in Phase 2 trials.
  • In NSCLC patients ineligible for standard care, uliledlimab combined with toripalimab achieved a 26% ORR and a 73.7% disease control rate.
  • Clinical responses to uliledlimab correlate with high CD73 expression in tumors, suggesting its potential as a predictive biomarker.
  • I-Mab plans to initiate a Phase 3 registrational clinical trial in NSCLC, pending regulatory approval, and explore uliledlimab in other cancers.

A Phase I/II Study of TJ004309 for Advanced Solid Tumor

NCT04322006Active, Not RecruitingPhase 1
TJ Biopharma Co., Ltd.
Posted 5/9/2020

FDA Approves Ivosidenib Plus Azacitidine for IDH1-Mutated Acute Myeloid Leukemia

  • The FDA has approved ivosidenib in combination with azacitidine for previously untreated IDH1-mutated acute myeloid leukemia (AML).
  • The approval was based on the phase 3 AGILE trial, which demonstrated a statistically significant improvement in event-free survival (EFS) and overall survival (OS).
  • The combination therapy is indicated for patients aged 75 years or older or those with comorbidities precluding intensive induction chemotherapy.
  • Ivosidenib targets cancer metabolism and has shown a favorable safety profile, marking a significant advancement in AML treatment.

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

NCT03173248Active, Not RecruitingPhase 3
Institut de Recherches Internationales Servier
Posted 6/26/2017

Phase II Study Shows Atacicept's Potential in Treating IgA Nephropathy

A phase II clinical trial, JANUS, evaluated the safety and efficacy of atacicept in patients with IgA nephropathy (IgAN) and persistent proteinuria. The study found atacicept to have an acceptable safety profile and demonstrated its effectiveness in reducing levels of pathogenic factor Gd-IgA1, with potential improvements in proteinuria and renal function.

Efficacy and Safety of Atacicept in IgA Nephropathy

NCT02808429TerminatedPhase 2
EMD Serono Research & Development Institute, Inc.
Posted 1/31/2017

Atacicept in Subjects With IgA Nephropathy

NCT04716231Active, Not RecruitingPhase 3
Vera Therapeutics, Inc.
Posted 5/23/2023

FDA Approves Epsolay for Inflammatory Lesions of Rosacea

• The FDA has approved Epsolay, a 5% encapsulated benzoyl peroxide cream, for treating inflammatory lesions of rosacea in adults. • Clinical trials showed Epsolay reduced inflammatory lesions by nearly 70% after 12 weeks, compared to 38-46% with the vehicle cream. • Almost 50% of patients achieved an IGA score of 0/1 at 12 weeks, indicating clear or almost clear skin, compared to placebo. • Epsolay utilizes microencapsulation technology to slowly release benzoyl peroxide, potentially reducing skin irritation.

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