Saol Therapeutics Announces Completion of Enrollment in Both the Phase II COMPASS Osteoarthritis Knee Pain Trial and the Phase II RAISE Limb Spasticity Trial

SL-1002 is currently being developed for the treatment of chronic knee pain associated with osteoarthritis (COMPASS Trial) and mild to severe limb spasticity (RAISE Trial). Topline data for the COMPASS Osteoarthritis Knee Pain Trial will be available in the first quarter of 2024, with topline data from the RAISE Limb Spasticity Trial available shortly thereafter. 

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Saol Therapeutics

ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, September 19, 2023 / PRNewswire/  – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that enrollment has been completed in the company’s two Phase II trials for SL-1002.

Both the COMPASS Osteoarthritis Knee Pain Trial ( NCT05470608 ) and the RAISE Limb Spasticity Trial ( NCT05311215 ) are each fully enrolled, at 132 patients and 32 patients, respectively.

SL-1002 is a novel, chemoneurolytic injection, that utilizes Saol’s proprietary CYCLOPHLEX TM  technology.

“Running parallel, multi-indication Phase II studies for SL-1002 has only been possible due to our committed investigator partners, their research teams, and the tireless work of the employees at Saol Therapeutics,” said David Penake, CEO of Saol Therapeutics.   “This is a tremendous milestone for our company, and we look forward to sharing the results with the medical community.  While celebrating this accomplishment, our team has already shifted into preparing for what will be necessary to initiate the Phase III programs and expansion to other important indications.”

The COMPASS Osteoarthritis Knee Pain Trial is a multicenter, randomized (3:1), double-blind, placebo-controlled, single ascending-dose escalation study to assess the safety and efficacy of SL-1002 for the treatment of chronic knee pain associated with osteoarthritis in adult patients.  The efficacy of SL-1002 will be assessed in comparison to placebo in its ability to reduce the average pain intensity at 3 months (12 weeks). The safety of SL-1002 will be assessed throughout the study compared to placebo when used for treating chronic knee pain associated with osteoarthritis.  Additional secondary measures include improvements in function, concomitant medication, and healthcare utilization.

“The completion of enrollment in the COMPASS Osteoarthritis Knee Pain Trial brings this therapy one step closer to ultimately helping patients,” said Principal Investigator Zachary McCormick, MD, Vice Chair and Associate Professor of Physical Medicine and Rehabilitation at the University of Utah.  “Recent developments in our understanding of the neuroanatomy of the knee indicate that this treatment could be incredibly beneficial to the millions of patients who deal with chronic pain related to osteoarthritis of the knee.  We have enjoyed collaborating with the Saol Therapeutics team and the 14 additional sites in the COMPASS trial. I look forward to seeing the results soon.”

The RAISE Limb Spasticity Trial is a randomized (3:1), double-blind, placebo-controlled single ascending dose escalation study intended to assess the safety, pharmacokinetics, and efficacy of a single treatment of SL-1002 in patients with mild to severe limb spasticity. Following randomization, the study period will be up to 26 weeks.  The primary endpoint is the overall safety profile of a single treatment exposure of SL-1002 in comparison to a placebo.

Saol Therapeutics currently expects topline results for the COMPASS Osteoarthritis Knee Pain Trial in the first quarter of 2024, and the RAISE Limb Spasticity Trial in the second quarter of 2024.

About COMPASS Osteoarthritis Knee Pain Trial

The COMPASS Osteoarthritis Knee Pain Trial is a multicenter, randomized, double-blind, placebo- CO ntrolled, single-ascending dose escalation study to assess the safety and efficacy of SL-1002 injectable for treat M ent of  PA in a SS ociated with  O steo A rthritis of the knee.  ( NCT05470608 ).

About RAISE Limb Spasticity Trial

The RAISE Limb Spasticity trial is a  R andomized double-blind, placebo-controlled, single  A scend I ng dose escalation study to assess the  S afety, Pharmacokinetics and  E fficacy of SL-1002 in adult patients with limb spasticity.  ( NCT05311215 ).

About SL-1002

SL-1002 is a novel, chemoneurolytic injection, that utilizes Saol’s proprietary CYCLOPHLEX TM  technology. It is currently being developed for the treatment of chronic knee pain related to osteoarthritis and limb spasticity, both in the adult population (18+) in the United States.

About Saol Therapeutics

Saol Therapeutics (pronounced “Sail”) is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, GA, Dublin, Ireland, and Hamilton, Bermuda.  Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases.  Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations.  For more information, visit  www.saolrx.com.

Saol Therapeutics Contact

Senior Vice President, Strategy
Brian Nappi
bnappi@saolrx.com

BIO Statement on the Section 232 Pharmaceutical Proclamation

April 4, 2026
April 2, 2026- WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) , released the following statement on Section 232 Pharmaceutical Proclamation. “A thriving American biotechnology ecosystem is essential to growing the U.S. economy, strengthening national security, and improving the health and well‑being of everyday Americans. While we appreciate the Administration’s recognition of the need for tariff exemptions for certain critical biotech products, the reality is that any tariffs on America’s medicines will raise costs, impede domestic manufacturing, and delay the development of new treatments - all while doing nothing to enhance our national security. “U.S. biotech companies have been eager to expand investments here at home, but tariffs, along with an uncertain policy environment and efforts to force “most‑favored nation” schemes, work directly against that goal. The risks are especially acute for small and mid‑size biotech companies, which develop more than half of all FDA‑approved medicines yet often lack the capital to build dedicated manufacturing facilities as they weather an industry defined by high costs, long development timelines, and significant risk. “The fact is: tariffs divert scarce resources away from research and development, weaken American biotech against China’s rising industry, and ultimately, harm health and economic wellbeing of Americans. “We stand ready to work with the Administration on a long‑term strategy that encourages biotechnology investment, reduces the time, cost, and uncertainty of developing new medicines, expands U.S. biomanufacturing capacity, and ensures American innovation is fairly valued overseas. Tariffs and MFN are not the answer." Source - https://www.bio.org/press-release/bio-statement-section-232-pharmaceutical-proclamation

Georgia Life Sciences Announces 2026 Georgia BioGENEius Challenge Winner

April 1, 2026
Atlanta, GA (April 1, 2026) – Georgia Life Sciences (GLS) is proud to announce that Saisurya Lakkimsetti, a junior at Lakeside High School in Columbia County, has been named the winner of the 2026 Georgia BioGENEius Challenge. The Georgia BioGENEius Challenge took place, as part of the statewide Georgia Science and Engineering Fair (GSEF) at the Classic Center in Athens, Georgia. Forty-seven students from across Georgia competed for this year’s title and cash prize. Jaehyeon Lee, an 11th-grade student from Walton High School, was named runner-up in this year’s competition. The Georgia BioGENEius Challenge recognizes outstanding high school students who are conducting innovative biotechnology research with real-world applications. This year’s top projects, presented in the Global Healthcare Challenge track, demonstrated exceptional scientific rigor and forward-thinking potential in addressing critical healthcare challenges. Saisurya’s research focuses on identifying potential inhibitors for Endocan, a protein known to play a role in glioblastoma tumor growth. Using advanced computational modeling techniques—including AlphaFold and molecular docking tools—she screened thousands of small molecules to identify compounds that may block tumor-promoting signaling pathways. Her work identified several promising candidates that could serve as a foundation for future drug development targeting glioblastoma. Jaehyeon’s project investigates how varying glucose concentrations affect regeneration in planaria, modeling impaired wound healing in diabetic conditions. By testing graded glucose environments and measuring regeneration indicators such as growth and differentiation, Jaehyeon demonstrated that lower glucose levels enhance regeneration while higher levels inhibit healing. The study establishes a model to better understand hyperglycemia’s impact on diabetic wound healing. “The work by these students is a powerful example of the innovation and determination we see in Georgia’s next generation of life sciences leaders,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences. “The BioGENEius Challenge is critical because it provides students with a platform to apply cutting-edge science to real-world problems, while also strengthening the future workforce that will drive breakthroughs in healthcare, biotechnology, and beyond.” The Georgia BioGENEius Challenge is part of Georgia Life Sciences’ broader commitment to advancing workforce development and fostering innovation across the state’s rapidly growing life sciences ecosystem. Judging the 2026 Georgia BioGENEius Challenge: Ian Biggs; Ralph Cordell, CDC; Alex Harvey, ViaMune; Jamie Graham, Smith Gambrell Russell; and Evan Scullin, LuminiSci.

Georgia Life Science's Feature in Very First Atlanta Edition of Inside Medicine

March 24, 2026
Georgia Life Sciences is thrilled to be featured in the very first Atlanta edition of Inside Medicine . This inaugural issue represents something truly special. Atlanta’s healthcare and life sciences community is driven by innovation, collaboration, and outstanding leadership—and we’re honored to be part of this exciting launch. Also in the issue, GLS's Kennedy Dumas is featured, sharing her journey on how observation and research evolved into a powerful practice of journaling. As the founder of Stationery Black, she creates notebooks designed to showcase, uplift, and inspire people of color. Read the full article here.
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