MoonLake Immunotherapeutics is set to launch an international Phase II clinical trial of investigational nanobody, sonelokimab, to treat moderate-to-severe hidradenitis suppurativa (HS).

Sonelokimab can potentially treat inflammatory disease by hindering the naturally seen IL-17A/A, IL-17A/F, and IL-17F/F dimers that induce inflammation.

It comprises three VHH domains that are covalently connected by flexible glycine-serine spacers and can also directly act on inflammation sites and enter hard-to-reach inflamed tissues.

The company filed a new protocol for HS as part of its investigational new drug application (IND) with the US Food and Drug Administration following the conclusion of an international Phase IIb trial in moderate-to-severe psoriasis.

Assessment process by the regulatory agency included a Type C meeting and statutory 30-day review period, during which no further comments were provided. 

The central Institutional Review Board granted approval for the protocol.

Named MIRA, the randomised, double-blind, placebo-controlled trial will analyse the safety and efficacy of varying doses of sonelokimab versus placebo in more than 200 subjects

The trial will have adalimumab as an active control reference arm.

Hidradenitis Suppurativa Clinical Response (HiSCR) 75 will be used as the primary endpoint of the trial. 

It is defined as a ≥75% decline in total abscess and inflammatory nodule count without a surge in abscess or draining tunnel count against the baseline.

Heterogeneous clinical phenotypes of the disease, including inflammatory lesions and tunnels and various subject-reported outcome measures such as pain and quality of life assessments, will be included as secondary endpoints.

The company anticipates initiating subject enrolment soon this year with the first study centres to be launched in the US.

MoonLake Immunotherapeutics founder and chief scientific officer Kristian Reich said: “Using an at least 75% improvement of HiSCR as the primary endpoint reflects our goal to reach for a greater reduction in disease markers than is typically tested in clinical trials. 

“We are excited to continue development of the first IL-17A- and IL-17F-targeting Nanobody as a potential novel treatment for chronic inflammatory conditions such as HS, with the aim of elevating outcomes for patients.”

A chronic skin condition, HS leads to the destruction of tissues that is irreversible and causes painful inflammatory skin lesions.