Calluna Pharma AS (Calluna), a medical stage biotechnology firm pioneering first-in-class antibodies to deal with inflammatory and fibrotic illnesses, as we speak introduced the completion of Section 1 medical research for CAL101, Calluna’s lead product candidate. The research demonstrated a good security, pharmacokinetic (PK) and immunogenicity profile for the mAb.
CAL101 is a first-in-class mAb that targets S100A4, a damage-associated molecular sample (DAMP) protein implicated in severe and life-threatening illnesses, equivalent to idiopathic pulmonary fibrosis and systemic sclerosis. Preclinical research have demonstrated the flexibility of CAL101 to stop and deal with fibrosis and modify the disease-specific activation of fibroblasts – the important thing effector cells driving development of fibrosis.
We’re inspired by the findings from the Section 1 research. These outcomes are an essential step ahead within the growth of our lead asset, CAL101, significantly for fibrotic and fibro-inflammatory illnesses the place there stays a vital want for modern therapeutic choices. We’re excited as we now transfer into the following part of medical growth.”
Jonas Hallén M.D., Ph.D., Co-Founder and Chief Medical Officer, Calluna Pharma
The primary-in-human, randomized, double-blind, placebo-controlled Section 1 research in 57 topics was designed to guage security, tolerability, immunogenicity and PK, and was led by Professor Dave Singh on the Medicines Analysis Unit in Manchester, UK. The research examined single ascending doses of CAL101 in wholesome volunteers and a number of ascending doses in sufferers with delicate to reasonable continual plaque psoriasis.
Abstract of key CAL101 Section 1 research outcomes:
- CAL101 demonstrated a good security profile and was properly tolerated with no Critical Antagonistic Occasions throughout all doses examined.
- Antagonistic Occasions had been all delicate to reasonable and balanced between CAL101 and placebo.
- CAL101 demonstrated a good PK profile with dose-dependent will increase in publicity, supporting as soon as month-to-month dosing.
- In members with anti-drug antibodies, titers had been very low and with no affect on PK and security.
- Goal engagement knowledge helps full goal protection at clinically related doses.