SAN DIEGO, Oct. 29, 2026 (GLOBE NEWSWIRE) — Biosplice Therapeutics, Inc. (“Biosplice”), a late-stage biopharmaceutical company developing lorecivivint (“LOR”), a first-in-class small-molecule inhibitor of CLK/DYRK kinases, for the treatment of knee osteoarthritis (“OA”), announced today that Erich Horsley, Chief Executive Officer, and Dr. Yusuf Yazici, Chief Medical Officer, will be featured on Health Uncensored with Dr. Drew on Sunday, November 1, 2026 at 5:30 p.m. ET on FOX Business Network. The segment covers the burden of knee osteoarthritis and the need for new treatment options, along with Biosplice’s development of lorecivivint over more than a decade.

LOR is a small-molecule suspension intended to be injected 1–2 times per year into the knee joint. It has been evaluated in eleven clinical trials, with improvements in joint structure, pain and function, together with a well-established safety profile. Evidence supportive of disease modification was generated primarily in Biosplice’s Phase 3 OA-07 trial, which showed that LOR improved medial joint space width (JSW) on imaging over multiple years. Patients treated with LOR maintained and ultimately improved their medial JSW, as measured by X-ray at two years following annual injections, and placebo patients whose medial JSW decreased during the first year showed increases after crossing over to active treatment. In the same trial, patients dosed with LOR significantly improved their pain scores at 6 months, and both pain and function at 12 months, compared with placebo. These results support LOR’s potential to be the first disease-modifying therapy for OA, a milestone long sought by patients, physicians and researchers.

LOR is under regulatory review in both the United Kingdom and the European Union. The Medicines and Healthcare products Regulatory Agency (“MHRA”) validated Biosplice’s application on August 28, 2026, and the European Medicines Agency (“EMA”) validated Biosplice’s marketing authorization application on September 30, 2026.

Erich Horsley, Chief Executive Officer of Biosplice, commented, “Fifty million American adults live with osteoarthritis, and most of them have been told to manage it rather than treat it. Very few people outside our field know that a medicine with disease-modifying potential is now in front of regulators. A program like this one reaches every-day patients that may not be used to sifting through clinical data, and we were glad to have the chance to explain in simple terms what we have spent more than a decade building.”

Patients who want to act on what they hear can visit fightOA.org. Visitors can share their own experience of living with osteoarthritis and have a letter prepared and sent on their behalf to the FDA and their two U.S. senators and representative in the U.S. House.

Biosplice has been developing LOR for over a decade and initially synthesized and identified the novel compound in 2011. LOR is a small-molecule drug that selectively inhibits two kinases, DYRK1A and CLK2. DYRK1A is an inflammatory kinase, the inhibition of which results in significant reductions in multiple inflammatory cytokines and catabolic enzymes that break down hyaline cartilage. Inhibition of CLK2 alters local Wnt pathway signaling, which is believed to promote chondrocyte formation and protect hyaline cartilage.

Any application for the approval of a new medicine in OA must be supported by data demonstrating that it is safe. Throughout the decade-long clinical development program, LOR’s safety profile has been consistent with that of placebo. LOR’s safety is enhanced by the fact that, when injected into the knee joint, the drug has no detectable systemic exposure.

About Osteoarthritis

Osteoarthritis (OA), the most common form of arthritis, is a serious chronic disease that affects an estimated 50 million U.S. adults and over 500 million adults globally.1 OA is the most prevalent joint disease and a leading source of chronic pain and disability in the United States. OA may affect the knees, hips, shoulders, hands, spine or great toes; current estimates indicate that about 25 million U.S. adults, 1 in 10, have knee OA alone.1 Although OA is often considered a disease of old age, approximately half of symptomatic knee OA diagnoses occur by age 55.2

Those who live with OA experience pain, stiffness and swelling, which limit their function and mobility, often impacting their daily lives. Functional limitations are present in about 80% of people with OA, and 25% are unable to perform major activities of daily living.3 Mortality is higher in patients with knee and hip OA largely due to cardiovascular disease, with a higher risk of death associated with severity of walking disability.4 Given both the increased morbidity and mortality, the U.S. FDA has accepted knee OA as a “serious condition.”

About Lorecivivint (LOR)

Lorecivivint is a small-molecule suspension drug intended to be injected into the intra-articular space of the knee for the treatment of OA. LOR has been tested as a once-per-year or every-six-month injection in Biosplice’s development program. LOR’s mechanism of action is based on selective and potent inhibition of DYRK1A and CLK2 kinases. DYRK1A inhibition has been shown to reduce inflammation and catabolic enzyme activity, and inhibition of CLK2 is believed to provide cartilage-protective and regenerative properties. The extensive clinical development program for LOR has provided evidence of statistically and clinically significant improvement in pain, function and medial JSW, with a well-established safety profile. LOR is an investigational medicine and has not been approved by the MHRA, the EMA, the FDA or any other regulatory authority.

About Biosplice

Biosplice is a late-stage biopharmaceutical company focused on lorecivivint, a first-in-class small-molecule inhibitor of CLK/DYRK kinases being developed as a potentially disease-modifying treatment for knee osteoarthritis. Biosplice’s work is grounded in novel biology linking CLK/DYRK kinases to the therapeutic regulation of alternative splicing. Lorecivivint is under regulatory review in the United Kingdom and the European Union. Biosplice also holds a majority interest in TenaRx, which is developing programs in oncology, diabetes and neurology. Learn more at https://www.biosplice.com.

About Health Uncensored with Dr. Drew

Health Uncensored with Dr. Drew is a groundbreaking health and wellness program hosted by Dr. Drew Pinsky, a board-certified physician in Internal and Addiction Medicine, as well as a renowned television host, author, and public speaker. Dr. Drew engages with a diverse range of experts, thought leaders, celebrities, and everyday people to provide viewers with practical advice, evidence-based information, and unfiltered discussions about wellness, mental health, and the importance of proactive health management. With a commitment to empowering audiences through education and open dialogue, Health Uncensored aims to explore the complex landscape of health, addresses pressing medical issues, implements better lifestyle choices, and shares the latest in medical research with candor and insight.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the MHRA’s and the EMA’s assessment of Biosplice’s marketing authorization applications for lorecivivint, the expected timing and outcome of those assessments, the review and potential approval of lorecivivint by the MHRA, the EMA or any other regulatory authority, and the therapeutic potential of lorecivivint. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by those statements. These include, among others, the uncertainties inherent in the regulatory review process, including the possibility that a regulatory authority may request additional information, may extend or suspend its review timetable, or may decline to grant approval, and other risks associated with drug development and commercialization. Statements regarding statutory review timetables reflect published regulatory guidance and are not assurances as to the timing of any regulatory decision. Biosplice undertakes no obligation to update or revise any forward-looking statements contained herein, whether as a result of new information, future events, or otherwise.

Corporate Contact:
Phil Wilson, CFO
Biosplice Therapeutics, Inc.
phil.wilson@biosplice.com

1 Institute for Health Metrics and Evaluation (IHME). GBD 2021 Results. Seattle, WA: IHME, University of Washington; accessed October 1, 2026. https://vizhub.healthdata.org/gbd-results/
2 Losina E, et al. Arthritis Care Res (Hoboken). 2013.
3 Neogi T. Osteoarthritis Cartilage. 2013.
4 Osteoarthritis Research Society (OARSI). Osteoarthritis: A Serious Disease. Published December 1, 2016. Accessed June 25, 2024. https://oarsi.org/sites/oarsi/files/docs/2016/oarsi_white_paper_oa_serious_disease_121416_1.pdf


Primary Logo

Media gallery

About The Author