Avalo Therapeutics Reports Highly Positive Phase 2 LOTUS Trial Results for Abdakibart in Hidradenitis Suppurativa

summarizeSummary

Avalo Therapeutics reported highly positive Phase 2 clinical trial results for abdakibart in hidradenitis suppurativa, meeting primary and secondary endpoints with strong efficacy and a favorable safety profile, leading to plans for a Phase 3 program.

check_boxKey Events

• Positive Phase 2 LOTUS Trial Results

  Abdakibart (AVTX-009) successfully met its primary endpoint in the Phase 2 LOTUS trial for moderate to severe hidradenitis suppurativa, demonstrating HiSCR75 response rates of 42.2% (150 mg) and 42.9% (300 mg) at Week 16, which are the highest observed in trials of this size or larger.

• Statistically Significant Secondary Endpoints

  The trial also showed statistically significant benefits across key secondary endpoints, including HiSCR50, change in IHS4, and change in draining tunnel count.

• Favorable Safety Profile

  Abdakibart was well-tolerated with a safety profile similar to placebo, and no unexpected safety findings or serious adverse events related to neutropenia, serious infections, or opportunistic infections were reported.

• Advancement to Phase 3 Program

  Based on these compelling data, Avalo Therapeutics plans to advance abdakibart into a registrational Phase 3 program, marking a significant de-risking event for the lead asset.

auto_awesomeAnalysis

Avalo Therapeutics announced highly positive topline results from its Phase 2 LOTUS trial for abdakibart (AVTX-009) in moderate to severe hidradenitis suppurativa. The trial successfully met its primary endpoint, demonstrating high response rates (HiSCR75) for both doses, which were noted as the highest observed in trials of this size or larger. Key secondary endpoints also showed statistically significant benefits, and abdakibart was well-tolerated with a favorable safety profile. These strong results de-risk the lead asset and provide a critical positive catalyst for the company, especially given its previous financial challenges and ongoing cash burn. The company plans to advance abdakibart into a registrational Phase 3 program, which could significantly enhance its long-term value and potential for future financing.