Calluna Pharma AS (Calluna), a medical stage biotechnology firm pioneering first-in-class antibodies to deal with inflammatory and fibrotic illnesses, right this moment introduced the completion of Section 1 medical examine for CAL101, Calluna’s lead product candidate. The examine 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 critical and life-threatening illnesses, reminiscent of 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 examine. These outcomes are an essential step ahead within the improvement of our lead asset, CAL101, notably for fibrotic and fibro-inflammatory illnesses the place there stays a important want for revolutionary therapeutic choices. We’re excited as we now transfer into the subsequent section of medical improvement.”
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 examine 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 examine examined single ascending doses of CAL101 in wholesome volunteers and a number of ascending doses in sufferers with gentle to average persistent plaque psoriasis.
Abstract of key CAL101 Section 1 examine outcomes:
CAL101 demonstrated a good security profile and was nicely tolerated with no Critical Antagonistic Occasions throughout all doses examined.
Antagonistic Occasions had been all gentle to average 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 contributors with anti-drug antibodies, titers had been very low and with no impression on PK and security.
Goal engagement information helps full goal protection at clinically related doses.
