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BridgeBio Pharma Affiliate Venthera Presents Preliminary Results From Clinical Trial Of VT30 (BBP-681) For Venous, Lymphatic And Venolymphatic Malformations

BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio) and its affiliate company Venthera, Inc. (Venthera), today announced preliminary data from the Phase 1b trial of VT30 topical gel (BBP-681) in patients with venous,

Benzinga · 06/10/2022 07:32

BridgeBio Pharma, Inc. (NASDAQ:BBIO) (BridgeBio) and its affiliate company Venthera, Inc. (Venthera), today announced preliminary data from the Phase 1b trial of VT30 topical gel (BBP-681) in patients with venous, lymphatic and mixed venolymphatic lesions of the skin (VM, LM and VLM, respectively), which are rare genetic vascular anomalies driven by dysregulated activation of intracellular PI3K. The data are being shared in a virtual presentation to the International Society for the Study of Vascular Anomalies (ISSVA).
 

"People living with cutaneous VMs and LMs can experience clinical complications including pain, bleeding, and impaired functioning of the affected area. To date, their treatment options are limited to interventional procedures and surgeries. We are pleased that the trial has achieved its goal of characterizing the tolerability of a range of dosage strengths in affected patients and we believe it has provided us with the data we need to make decisions on the future direction of the program," said Thomas Rossi, Ph.D., Chief Executive Officer of Venthera.

The data presented are preliminary results from an open-label, dose-finding study of VT30 topical gel in patients with cutaneous VM/LM/VLM lesions associated with mutations that result in dysregulated PI3K activation. VT30 topical gel is designed to potently inhibit PI3K in the treated tissue without systemic side effects. Early findings include:

  • Across 15 subjects treated in escalating-dose cohorts, VT30 topical gel has been generally well-tolerated; local self-limited rash was the only adverse experience of note, occurring at an increased incidence with the highest gel concentration. All reported adverse experiences were characterized as mild to moderate.
  • Pharmacokinetic and pharmacodynamic skin punch biopsies were taken from within the lesion. These data demonstrate that high concentrations of drug (in the micromolar range) are present in the lesion at day 28 and show a reduction of pS6 in the lesion from baseline to day 28.
  • No circulating drug was detected in plasma with any of the gel strengths studied.
     

Based on the findings shared during ISSVA 2022, Venthera has tentatively selected the 0.6% gel for further study. Venthera is currently seeking partners to support development of VT30 topical gel in Phase 2. To learn more, please contact licensing@bridgebio.com.

For more information about study specifics, see ClinicalTrials.gov (NCT04409145).