IP Group (LSE:IPO) has reported that Instesso has provided its shareholders with the results of its 12-week randomized, double-blind, placebo controlled Phase 2b study of leramistat in patients with moderate-to-severe rheumatoid arthritis (RA) with an inadequate response to treatment with methotrexate.
According to Intesso, while the study did not meet the primary endpoint of improvements in ACR20 versus placebo, leramistat did demonstrate statistically significant reductions in the key secondary endpoint of bone erosions, as well as improvements in disability and fatigue.
The company noted that these findings demonstrate leramistat’s unique mechanism of action and support further evaluation of its potential to promote adaptive tissue repair in combination with existing disease-modifying anti-rheumatic drugs in RA, as well as in other chronic conditions.
Intesso underscored that treatment with leramistat significantly reduced or stopped the progression of bone erosions. The company explained that bone erosions are a central feature of RA and appear early in the course of the disease. Progression of bone erosions leads to bone damage and is a major driver of disability and increased mortality in people living with RA.
In addition, the company reported that no new safety concerns were identified in the study. The adverse event (AE) rate was similar between groups receiving leramistat and placebo, and the majority of AEs were mild in nature and resolved without treatment. No deaths were reported and no significant changes in clinical chemistry, bloods, vital signs or cardiovascular health have been noted in leramistat trials to date.
Istesso intends to publish full study results at length and plans further Phase 2 studies to evaluate leramistat’s unique potential to promote adaptive tissue repair in RA, as well as other chronic conditions. Istesso is sufficiently funded to conduct these studies.
In a statement, Greg Smith, CEO of IP, said, “We are encouraged that these results are consistent with leramistat’s unique mechanism of action which supports and augments tissue repair. In addition, the impact on disability and fatigue, from which a large proportion of RA patients continue to suffer despite the widespread availability of current medications, is also highly promising.”
“Istesso will carry out additional work to evaluate leramistat’s potential to address these unmet needs and to promote adaptive tissue repair in RA and other chronic conditions, potentially in combination with existing therapies. Based on these data, we continue to believe in the market opportunity for leramistat to improve patients’ health and deliver significant value for shareholders,” he added.
IP has an undiluted holding of 56.5% in Istesso and anticipates providing a further update on Istesso, including its valuation, in its 2024 results that will be published next month.
