Avalo Therapeutics, Inc. (NASDAQ: AVTX) saw its shares rise 35% after the market close on Tuesday following the release of positive topline data from its Phase 2 LOTUS trial evaluating abdakibart in adults with moderate to severe hidradenitis suppurativa.
The company reported that the study met its primary efficacy endpoint - HiSCR75 - for both dose levels tested. At Week 16, the 150 mg dose produced a HiSCR75 response rate of 42.2%, while the 300 mg dose produced a response rate of 42.9%. Avalo noted these response levels represent the highest rates observed in a trial of this size or larger.
The LOTUS study enrolled 253 adults in a randomized, double-blind, placebo-controlled design. Participants were assigned to one of two abdakibart dosing regimens or placebo and treated over a 16-week period. The primary endpoint results cited absolute response rates of 42.2% and 42.9% at Week 16 for the two active dose arms, compared with a placebo rate of 25.6%.
In addition to the primary endpoint, abdakibart demonstrated statistically significant benefit on several key secondary measures, including HiSCR50, change in IHS4, and change in draining tunnel count. The company characterized the safety profile as favorable and reported the most common adverse events were headache and nausea. No adverse events related to neutropenia, serious infections, or opportunistic infections were observed in the reported data.
Following these topline findings, Avalo said it plans to move abdakibart into a registrational Phase 3 program. The company also expects to present the full LOTUS dataset at an upcoming medical congress; full results were not included in the topline summary.
Separately, Avalo announced the commencement of an underwritten public offering of common stock and pre-funded warrants. The company stated its intent to use the net proceeds to advance clinical development of abdakibart - including support for its Phase 3 topline data release - as well as for working capital and general corporate purposes. Leerink Partners, TD Cowen and BofA Securities are serving as joint bookrunning managers for the offering.
Implications
The disclosed data provide a clinical catalyst for the company by supporting progression into a registrational program. The simultaneous equity offering indicates Avalo is seeking to secure capital to fund that next stage of clinical development and near-term corporate needs.
What remains pending
- Full LOTUS results to be presented at an upcoming medical congress - the topline release does not replace the detailed dataset.
- Advancement into and outcomes from a planned Phase 3 registrational program, which the company intends to initiate based on these Phase 2 topline results.
- The completion and terms of the announced underwritten public offering and its impact on company capital structure.