Australian life sciences company Cellmid (ASX: CDY) has announced positive efficacy results of a study using its anti-midkine antibody CAB102 in the treatment of rare kidney disease focal segmental glomerulosclerosis.
The study, performed at the Westmead Institute for Medical Research, confirmed previous findings that blocking midkine alleviates damage to the kidney and prevents ensuing defects in renal function brought on by FSGS.
Midkine has been identified as a contributor in several kidney disorders and blocking the action of midkine has been shown to improve disease outcomes in animal models.
Earlier studies have shown that Cellmid’s murine antibody IP14 can preserve renal structure and function.
The CAB102 antibody represents the humanised form of IP14 and Cellmid said it has been shown to be equally as effective as its murine precursor.
The findings have been considered a “critical step” in progressing Cellmid’s antibody assets towards clinical trials in kidney patients.
Chief executive Maria Halasz said it allows the company to apply to the US Food and Drug Administration and European Medicines Agency for CAB102 Orphan Drug Designation, which holds benefits such as tax credits for costs of clinical trials, fee waivers and eligibility for seven years of marketing exclusivity.
“We are excited that engagement with some of the leading renal clinicians and researchers in the field of chronic kidney disease globally has lead us one step closer to clinical deployment of our anti-midkine assets,” she said.
In a January 2017 announcement regarding a study on mice with kidney damage resembling human FSGS, Cellmid – through its wholly-owned subsidiary Lyramid – showed IP14 could prevent kidney injury, glomerular scarring and repressed inflammatory cell infiltration into the kidney, resulting in preserved renal function.
Highly-expressed in embryonic development but barely detectable in healthy adults, midkine is a basic protein responsible for modulating biological interactions such as cell growth, cell migration and cellular adherence.
These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth and repair, and wound healing.
Midkine occurs as a consequence of the pathogenesis of a number of different disorders – its expression is often evident in the early onset stage, before physical symptoms, and is considered an important marker for diagnosing cancers and autoimmune diseases.
Midkine is only evident in a disease context, and targeting midkine is not expected to harm normal healthy tissues.
Previous studies by Cellmid using a variety of strategies to block midkine have minimised kidney injury and preserved renal function in a number of experimental models of acute and chronic kidney disease.
Share purchase plan
Earlier this month, Cellmid announced the completion of a share purchase plan launched in July to advance of its other business interests.
The company received applications to the value of $1,025,000 for the issuing of 2,697,377 shares – representing an increase of $25,000 on the maximum $1 million originally determined by the board of directors.
The plan was offered at the same price as a simultaneous share placement to sophisticated and institutional investors for $9 million.
Cellmid said the funds raised under the share purchase plan and the private placement will be used to drive growth in the consumer health business globally, with emphasis on its flagship évolis hair growth product range and its exclusive agreement announced in April with Italy’s Labo International S.r.l to distribute the Fillerina range of anti-aging skincare products in Australia and New Zealand.
At midday, shares in Cellmid were trading 2.63% higher at $0.39.