Veloce BioPharma Announces Positive Phase 2b Study Results for VBP-926 (Topical Povidone-Iodine in a Novel Non-Aqueous Vehicle)

Food and Healthcare Press Releases Thursday October 4, 2018 13:40
FORT LAUDERDALE, Florida--4 Oct--PRNewswire/InfoQuest
Veloce BioPharma Announces Positive Phase 2b Study Results for VBP-926 (Topical Povidone-Iodine in a Novel Non-Aqueous Vehicle) in Subjects with Chemotherapy-Associated Paronychia
  • Veloce BioPharma's VBP-926 (Povidone-Iodine) Demonstrates Statistically Significant and Clinically Significant Results in Phase 2b Study for Chemotherapy-Associated Paronychia
  • Positive clinical results provide basis for pivotal Phase 3 clinical trials

Veloce BioPharma, LLC ("Veloce"), a clinical-stage biopharmaceutical company dedicated to developing topical therapeutics for unmet needs in dermatologic and ophthalmic diseases, today announced positive results of its Phase 2b study of dilute povidone-iodine in a novel DMSO solvent system for the topical treatment of chemotherapy-associated paronychia, or painful and inflamed nail units resulting as a side effect of chemotherapy.

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia. Results from the study showed that VBP-926 (2%) met the primary efficacy endpoint of grade-improvement on the Paronychia Severity Grading Scale. Consistent with previously reported case series results, VBP-926 was well-tolerated at both doses and provided both morphological resolution and symptomatic relief in affected nails.

"This trial clearly demonstrated the clinical benefit of VBP-926 2% solution," said Dr. Kara Capriotti, MD, President and Director of Dermatology programs at Veloce. "We are well positioned to move VBP-926 into Phase 3 development and continue advancing a product that targets an indication with no approved therapies. Addressing the pain and discomfort suffered by patients with chemotherapy-associated paronychia is an enormous unmet need and we are encouraged to be getting closer to a topical therapy that can solve this problem."

Phase 2b results showed that VBP-926 at the higher concentration met the primary efficacy endpoint. The 2% dose reached statistical significance for nail grade improvement from baseline to the end of therapy for change in the Paronychia Severity Grading Scale (p=.0003). No treatment-related serious adverse events were reported. Adverse events were mild in severity and reversible when treatment was discontinued.

Mario Lacouture, MD, Director, Oncodermatology Program at Memorial Sloan Kettering Cancer Center and Lead Investigator of the trial, commented, "Chemotherapy-associated paronychia is a frequent side effect of cancer treatments, and may impair quality of life and administration of anti-cancer treatments. This study is of interest, as it showed a significant reduction in paronychia score at the higher concentration of VBP-926 solution." Dr. Lacouture's research was funded by Veloce BioPharma.

About VBP-926
VBP-926 is a broad-spectrum, resistance-free biocidal topical solution that has the ability to eradicate all known microorganisms including bacteria, viruses, yeasts, molds, fungi and protozoa.
About Chemotherapy-Associated Paronychia

Systemic chemotherapy employed for the treatment of a variety of common malignancies can induce painful nail changes associated with mixed polymicrobial infections in a subset of patients. Iatrogenic paronychia has been clearly associated with numerous classes of cancer chemotherapies. Epidermal Growth Factor Receptor Inhibitors, taxanes, MEK inhibitors, mTOR inhibitors, anthracyclines and DNA/RNA synthesis inhibitors are known inciting drugs. Nail changes associated with higher morbidity include periungual erythema, edema, exudate, suppurative onycholysis and periungual or subungual pyogenic granuloma.

About Veloce BioPharma
Veloce BioPharma, LLC is a privately held clinical-stage pharmaceutical company focused on the development of topical therapeutics for unmet needs in dermatology and ophthalmology.
For more information, please contact:
Veloce BioPharma:
Kara Capriotti, MD
President, Veloce BioPharma LLC
kcapriotti@velocebiopharma.com
For Business Development Inquiries:
Triad Securities Corp.
Mark Palmer
Managing Director
mpalmer@triadsecurities.com
Logo - https://mma.prnewswire.com/media/753707/Veloce_BioPharma_Logo.jpg

Latest Press Release

The Menarini Group Announces Meropenem/vaborbactam European Marketing Authorization

- Meropenem/vaborbactam approved on 20th November 2018 by the European Commission for clinical use in adult patients with difficult-to-treat infections - The first combination of a carbapenem and a beta-lactamase inhibitor approved for clinical use in...

Merck Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

- FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer - First regulatory designation for M7824 following recent presentation of first clinical data in BTC - BTC is a group of rare, aggressive...

Merck in Agreement With Cyclica for AI-augmented Screening Platform to Expand Research Capabilities

- Agreement to screen discovery and early development compounds using artificial intelligence and computational biophysics - Cloud-based in silico platform that screens small molecules to determine polypharmacological profiles - Evaluation to include...

Vitality-linked Insurers to Get 100 million People 20% More Active by 2025

Building on the results of the largest behaviour change study on physical activity, Vitality and its global network of insurers have collectively committed to improving the health of millions over the next seven years. This is in line with the World...

World Congress of Cardiology Cardiovascular Health 2018 Opens in Dubai

- Professor David Wood, President of the World Heart Federation, welcomes more than 5000 cardiologists, doctors, nurses, and health and policy experts from around the world to Dubai for WCC 2018 at a time when the opportunities for a sustainable impact...

Related Topics