Biosplice Announces Upcoming Presentation of Successful OA-07 Phase 3 Long-Term Structure and Pain & Function Results for Lorecivivint for Treatment of Knee Osteoarthritis at OARSI Conference, and Completion and Preliminary Analysis of OA-21 Trial 12-Week
18 April 2024 - 8:00PM
Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage
biotechnology company pioneering first-in-class therapeutics based
on small-molecule inhibition of CLK/DYRK kinases, recently
completed two Phase 3 trials, OA-07 long-term structure, pain and
function study, and OA-21 short-term pain study. Preliminary
results of OA-07 study, initially reported in November 2023, had
demonstrated statistically significant and clinically meaningful
improvement in joint structure demonstrated by X-ray results of
medial joint space width (medial JSW). Final analysis of OA-07
results confirmed this structural benefit and further demonstrated
that patients also experienced statistically significant reduction
in their pain (as measured by WOMAC Pain at Month 6 and Month 12)
and significant improvement in function (as measured by WOMAC
Function at Month 12). Biosplice will present its OA-07 results at
the Osteoarthritis Research Society International (“OARSI”) World
Congress, April 18-21, 2024, in Vienna, Austria.
“Patients are desperately seeking a new and safe approach for
treating knee osteoarthritis that can provide durable pain relief,
improved function, and joint structure benefit,” commented
Biosplice Chief Medical Officer, Dr. Yusuf Yazici. “We are very
encouraged by our unique data from our OA development program, and
especially the recent OA-07 trial, and look forward to sharing
these results with the medical community in upcoming meetings.”
With respect to the shorter-term OA-21 study, preliminary
analysis showed that the study did not meet the primary endpoint of
pain reduction at Week 12. The Company observed an unusually high
placebo response in this trial compared to published
intra-articular OA trials and Biosplice’s prior trials. The Company
is currently analyzing these preliminary OA-21 results to further
discern what may have caused this result in contrast with the
successful OA-07 results, as well as the successful short- and
long-term pain and function results of the OA-04 Phase 2 study.
The primary goal of Biosplice OA program has been to develop a
first-in-class drug that could provide the more than 30 million OA
patients in the US, and many more worldwide, with an effective
treatment option that would go beyond mere short term pain relief.
The cumulative data from Biosplice’s OA program to date, especially
in light of the final results of the OA-07 Phase 3 X-ray study,
provide strong support in service of this goal. OA-07 study results
show that lorecivivint (1) provided a structural benefit in a
statistically significant and clinically meaningful manner in
moderate and advanced OA patients, a first-in-class attribute among
OA treatment options, (2) reduced patients’ pain, (3) improved
their function with (4) a remarkably clean safety profile to
date.
With the benefit of these clinical results, Biosplice intends to
consult with the US Food and Drug Administration (FDA), as well as
regulatory agencies in other countries, for further guidance on the
path to marketing approval of lorecivivint.
About BiospliceBiosplice stands at the
forefront of research concentrating on the study and regulation of
Cdc2-like kinases (CLKs) and dual-specificity tyrosine-regulated
kinases (DYRKs). These kinases play pivotal roles in cell cycle
regulation, splicing, and neurodevelopment, marking them as
critical targets for therapeutic intervention in a range of
diseases, including osteoarthritis, cancer, neurological disorders,
and diabetes. With a robust chemical platform for kinase inhibition
and a deep understanding of kinase signaling pathways, Biosplice
leverages cutting-edge technologies to discover and develop highly
selective kinase inhibitors. Biosplice’s drugs in clinical
development include lorecivivint for osteoarthritis and cirtuvivint
for numerous cancers, with a broad pre-clinical pipeline that
encompasses Alzheimer’s disease, diabetes and other degenerative
conditions.
Learn more at https://www.biosplice.com
Corporate Contact:Erich
Horsleyerich.horsley@biosplice.com