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

By Maria Thacker Goethe August 1, 2025
As Washington heads into August recess, Georgia Life Sciences is counting down the days to the 2025 Georgia Life Sciences Summit , taking place August 26–27 in Sandy Springs . With just one month to go, this pivotal gathering will bring together innovators, investors, policymakers, and ecosystem leaders at a time when the national policy landscape is shifting rapidly—and not always in our favor. In just the past week, we’ve seen: A short-lived but deeply disruptive pause in NIH funding : The White House Office of Management and Budget (OMB) temporarily halted the issuance of NIH research grants, contracts, and training awards—impacting institutions nationwide, including here in Georgia. After significant backlash from Congress, research leaders, and advocacy groups, the administration quickly reversed course and released the funds. However, this episode underscores the growing unpredictability of federal research funding—one of the lifelines for our academic and startup ecosystem. The return of pharmaceutical tariffs : The administration announced a 15% tariff on European pharmaceutical imports , though it will not take effect until a national security review is completed. While far lower than the previously floated 200% rate, this move still poses a concern for supply chains and U.S. companies relying on EU-based manufacturing. Escalating pressure on drug pricing : President Trump has now issued direct letters to CEOs of 17 major pharmaceutical companies demanding implementation of Most Favored Nation (MFN) pricing within 60 days. The directive includes MFN pricing for all existing Medicaid drugs, future Medicare and commercial launches, and even repatriation of foreign revenues. While regulatory specifics remain vague, the message is clear: the administration is increasing its pressure on pricing reform—and that could have broad implications for biotech innovation, particularly among smaller companies. At the same time, a new BIO report shows that early-stage biotech funding continues to contract. Series A investment remains flat, IPOs are sluggish, and Q2 startup funding dropped to just $900 million—down from $2.6 billion in Q1. Layoffs across the sector have surged. This paints a sobering picture for many companies in Georgia and beyond. In this environment, Georgia Life Sciences remains committed to elevating our state’s voice, regionally and nationally . We continue to advocate for stable federal funding, smart policies, and the resources innovators need to survive and thrive. The Georgia Life Sciences Summit will be a platform to do just that, demonstrating the resilience of our ecosystem, celebrating homegrown successes, and shaping the future of health innovation in Georgia. I hope to see you there.
By Maria Thacker Goethe July 28, 2025
By: Clary Estes “Small companies are the lifeblood of the industry and a lot of what they do, and what they’re experiencing, greatly affects the industry as a whole,” said Chad Wessel, Director of Industry Analysis at the Biotechnology Innovation Organization (BIO). He spoke with Bio.News in an interview about BIO’s 2025 report, “ The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends ,” focused on the biotech industry from the early-stage perspective. As researchers found, the current landscape is challenging, but there are still opportunities. “In the last couple years, we’ve had a little bit of a contraction of the industry. During COVID, we kind of had this sugar rush for the industry,” said Wessel. “A lot of companies were being created. A lot of money was being thrown out there. A lot more companies were being funded. And in the last couple of years, there has been a little bit more of a correction, and we’re seeing funding levels going down to what we’ve seen prior to COVID.” “But when you add on other challenges, like the political landscape and everything, it is leaning towards a very challenging environment for a lot of companies,” he continued. Bearish venture capital “In venture capital, yes, you have a lot of money, but it’s going to fewer companies at higher average amounts,” explained Wessel. “It’s creating this competitive haves and have-nots type marketplace or environment. So it just makes it a lot more competitive and more challenging to raise funds.” Instead of finding new opportunities, venture capitalists are investing more in companies they are already working with. As the BIO report found, the amount of new series A-1 investment rounds into biopharma remained flat between 2023 and 2024, while the number of U.S. companies receiving their first series A-1 tranche went from 102 to 100. This is in comparison to 181 in 2021, reflecting the COVID influx to emerging biotechs. Comparatively, as the BIO report found, the average amount for A-1 transactions in the U.S. saw a remarkable increase of 700% in the last 15 years, with the average amount raised sitting at $60 million in 2024. The rest of the world stayed relatively steady in comparison to the U.S.’s persistent growth. And with the more bearish tendencies of investors, Wessel and team observed an interesting trend. “2024 was the first year that clinical programs actually raised more venture dollars than pre-clinical, which hasn’t happened in a while,” said Wessel. “I think the last time that happened was in 2018. This ties into some of the information that we’ve heard anecdotally, which is that a lot of VC firms are focusing on the companies that they currently have in their portfolio, rather than adding new companies.” Licensing and deals dip It is not too surprising, then, that as investors shore up what they already have in the pipelines, the R&D pipeline and licensing have slowed somewhat. As the BIO report observed, long-term growth in the R&D pipeline continues with an overall growth of 145% since 2010. Yet, the 2024 expansion rate (4.6%) subsided slightly, trailing the 5-year average of 6.7%. “The growth has slowed on new programs, and more of those programs are being licensed with larger companies,” explained Wessel. “There are fewer options for big companies to backfill their pipeline with products because a lot of them are already out.” The data also shows a notable slowing of the R&D typically done by large biopharma companies. “The areas that are not licensed out as much are the ones with some of the higher patient populations and subsequently the ones that are not being run by small companies,” said Wessel. “These are areas like endocrine and cardiovascular diseases, which are areas where there are a lot of things like type 2 diabetes, psoriasis , high blood pressure, etc. Those all have a lot of burden on the healthcare sector or the patient population, and those aren’t really being worked on that much by smaller companies.” Comparatively – and also not surprisingly – oncology has stayed at the top of the clinical pipeline, along with neurology and infectious disease. “Same thing with licensing,” said Wessel. “While there are deals that are still happening, the upfront amount is lower currently than it has been in years past, and most of the value is tied up into milestone payments, which may or may not happen.” This is also being felt when it comes to new companies going public, which has been an oft-discussed challenge in the biotech industry for the last few years. “The IPO market has still been challenging,” Wessel says. “We went from having 40 companies a year going public, down to 15 in 2023, and now we’re back up in 2025, but it’s still down from the pre-COVID era timeframe.” Biopharma layoffs Another notable characteristic of this year’s biopharma landscape has been uptick in layoffs. “Sometimes it’s just the nature of the economy. But the amount that we’ve seen in the last few years is quite a bit higher,” said Wessel. “To counter that, we don’t really have a way of measuring job creation, but we do know it’s happening. We just are unable to put a value on that.” The BIO report found that layoff announcements ticked up to 65 during Q1 of 2025. While two points lower than Q1 of the previous year, this still marks a jump from 2024’s Q2, Q3, and Q4, which saw the number of layoff announcements at 41, 54, and 46, respectively. All in all, Wessel noted, the biotech industry is still in a bit of a holding period when it comes to trying to navigate the coming months. “It’s too early to be able to say much about the coming years for the industry based on these numbers,” he said. “It takes a little time for reality to kind of catch up for multiple reasons. But what I can say is that we do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge of raising funds and continue doing their best to try to maintain operations as long as they can until they can get funds.” “We know the challenge is out there, but we’re going to have to kind of wait and see a little bit on the data side of things to understand how everything is going to catch up going forward.” Source: https://bio.news/bioeconomy/bio-2025-state-of-emerging-biotechs-report-market-trends/?mkt_tok=NDkwLUVIWi05OTkAAAGb7m5php-rTOf0a_GTaj5pj7Zl-HlpVM25WtyVvCYudM82a9GKjoazUg9sqU66hlAbhqbEuYvcX3C4EqfBG7Q
By Maria Thacker Goethe July 26, 2025
Pioneer Institute has released updated #340B state fact sheets for 2025
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