Avalo's Monthly HS Injection Clears Phase 2 With 43% Response Rate
Avalo's abdakibart hit a 43 percent HiSCR75 response in phase 2 for hidradenitis suppurativa, roughly 17 points above placebo, with a once-monthly dosing option.
Updated
The takeaway
- In a 253-patient phase 2 trial, about 43 percent of patients on abdakibart achieved at least a 75 percent reduction in inflamed bumps and abscesses at week 16, versus about 26 percent on placebo.
- Abdakibart blocks IL-1β, an inflammatory pathway not targeted by currently approved HS biologics, which act on TNF or IL-17.
- Avalo Therapeutics plans to advance abdakibart into a pivotal phase 3 registrational program; full phase 2 results are expected at an upcoming medical meeting.
Abdakibart, an experimental injectable from Avalo Therapeutics, cut inflamed bumps and abscesses by at least 75 percent in about 43 percent of moderate to severe hidradenitis suppurativa patients after 16 weeks — roughly 17 points above placebo.
The phase 2 results, reported by Dermatology Times, position the drug as the first HS biologic aimed at IL-1β, an inflammatory messenger that differs from the TNF and IL-17 targets of current treatments.
The trial numbers
The study enrolled 253 adults. Participants received abdakibart every four weeks, every two weeks, or a placebo over 16 weeks. By the endpoint, about 43 percent of patients on either dosing schedule reached a 75 percent reduction in the combined count of inflamed bumps and abscesses, compared with about 26 percent on placebo.
Abdakibart also significantly improved draining tunnel counts and overall disease severity. Pain results favored the treatment but did not reach statistical significance.
Response rates on the trial's main measure held whether or not patients had tried other biologics before. Both dosing schedules performed consistently — a point that matters for Avalo's pitch of a once-monthly regimen.
A different target
Abdakibart is a lab-made antibody that blocks IL-1β, which may help fuel the bumps and abscesses of HS. No approved HS biologic works on this pathway, which could make the drug an option for patients who have not responded to existing therapies.
"We are proud to report that abdakibart has delivered a strong, consistent, and deep response across both the HiSCR75 and HiSCR50 endpoints in our phase 2 trial. This achievement powerfully validates the clinical promise of IL-1β inhibition for HS," said Garry Neil, MD, chief executive officer of Avalo Therapeutics. "This de-risking data set gives us tremendous confidence to advance abdakibart into a pivotal phase 3 registrational program. With a differentiated and patient-friendly potential monthly dosing regimen, we aim to offer a truly innovative mechanism of action to the HS community."
John Frew, PhD, professor of dermatology at the University of New South Wales in Sydney, called the findings encouraging for patients still searching for relief. "These phase 2 results are highly promising for the HS community," Frew said. "Achieving this level of improvement suggests that IL-1β inhibition with abdakibart may offer a meaningful new therapeutic option for people with HS who continue to struggle with this disease. The physical and emotional burden of HS is profound, and I am encouraged to see an investigational therapy showing such robust and clinically relevant results."
Safety profile
Side effects occurred at similar rates in the treatment and placebo groups and were mostly mild to moderate. Headache and nausea were the most common. Investigators reported no unexpected safety concerns during the 16-week trial, no serious or opportunistic infections, and no adverse events related to neutropenia, a drop in infection-fighting white blood cells.
What happens next
Avalo plans to move abdakibart into phase 3 trials. Full results from the phase 2 study are expected at an upcoming medical meeting. The drug remains years from potential approval, but for HS patients who have not found relief with current TNF and IL-17 inhibitors, abdakibart's monthly dosing schedule and novel target make it one of the most credible candidates now in the pipeline.
Original: dermatologytimes.com
More from Olivia Hart
Show full bio
Senior reporter covering business strategy at Eurasian Beauty Journal.
42 articles
