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Tuesday, November 7, 2023

Lumos Topline Data from Phase 2 Trials Met All Primary and Secondary Endpoints

 

  • OraGrowtH210 Results Show LUM-201 Dose of 1.6 mg/kg Achieves Annualized Height Velocities (AHV) of 8.2 cm/yr at 6 Months and 8.0 cm/yr at 12 Months, Comparable to Growth Rates for Moderate PGHD Population
  • Delta at 6 and 12-month AHV Between Optimal LUM-201 Dose of 1.6 mg/kg and rhGH Comparator Arm is Within the Non-inferiority Margin (< 2 cm/yr) Suggested by FDA for Recent Approvals
  • Initial 24-month LUM-201 Data from Combined OraGrowtH210 and OraGrowtH212 Trials Demonstrate a Sustained AHV Effect from Year 1 to Year 2
  • Met Pre-specified Primary Endpoint of Validation of Predictive Enrichment Marker (PEM) Test and Secondary Endpoint Demonstrating 100% Reproducibility of PEM-Positive Classification
  • OraGrowtH212 Demonstrated That, with Only 20% the GH Concentration of Injectable rhGH, LUM-201 Achieved Expected AHV While Demonstrating the Unique Pulsatile Mechanism of Action of LUM-201††
  • No Safety Signal to Date for LUM-201

Company to Host Conference Call Tomorrow Morning at 8:30AM ET

Conference Call and Webcast Details

Date: November 8, 2023
Time: 8:30 AM ET
Dial-in: 1-877-407-9716 or 1-201-493-6779 (international)
Conference ID: 13742617
Or Dial-in registration (Available 15 minutes prior to scheduled start time): https://callme.viavid.com/viavid/?callme=true&passcode=13742617&h=true&info=company-email&r=true&B=6
Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1642841&tp_key=d9efda8a69

https://www.globenewswire.com/news-release/2023/11/07/2775552/15114/en/Lumos-Pharma-Announces-Topline-Data-from-Phase-2-OraGrowtH210-and-OraGrowtH212-Trials-of-LUM-201-in-PGHD-Met-All-Primary-and-Secondary-Endpoints.html

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