Recursion to Present Preliminary Clinical Data from the Ongoing Phase 1b/2 trial of REC-4881 in FAP at Digestive Disease Week 2025

Rhea-AI Summary

Recursion (NASDAQ: RXRX) will present preliminary clinical data from its Phase 1b/2 TUPELO trial of REC-4881 for familial adenomatous polyposis (FAP) at Digestive Disease Week 2025. The presentation will take place on May 4, 2025, in San Diego.

Key preliminary findings as of February 7, 2025, show:

• 13 patients received 4 mg of REC-4881 daily
• 84.6% experienced at least one treatment-related adverse event
• Most common side effect was rash/dermatitis acneiform (Grade 1 or 2)
• 5 efficacy-evaluable patients showed >30% median reduction in total polyp burden after 12 weeks

REC-4881, identified through Recursion's AI-powered platform, has received Fast Track and Orphan Drug designations from the FDA and European Commission. FAP affects approximately 50,000 people across the US and major European countries, with no current FDA-approved therapies available.

Positive

• Preliminary efficacy shows >30% median reduction in polyp burden after 12 weeks
• Fast Track and Orphan Drug designations secured from FDA and European Commission
• Addressing an unmet medical need with no current FDA-approved therapies
• Treatment-related adverse events primarily mild to moderate (Grade 1 or 2)

Negative

• High percentage (84.6%) of patients experienced treatment-related adverse events
• Small patient sample size (only 5 efficacy-evaluable patients) in preliminary data
• efficacy data available at this stage

Insights

Oncology Clinical Researcher

Recursion's REC-4881 shows promising early efficacy with >30% polyp reduction in FAP patients, addressing an unmet need with manageable safety profile.

The preliminary data from Recursion's Phase 1b/2 TUPELO trial demonstrates a clinically meaningful signal for REC-4881 in familial adenomatous polyposis (FAP) - a rare genetic condition with no FDA-approved therapies. The >30% median reduction in polyp burden after just 12 weeks in the 5 efficacy-evaluable patients represents a potentially significant benefit for patients who currently face inevitable progression to colorectal cancer without surgical colon removal.

The safety profile shows 84.6% of patients experienced treatment-related adverse events, primarily Grade 1-2 rash/dermatitis acneiform, which is consistent with expectations for MEK inhibitors and appears manageable. The small sample size (13 patients) warrants caution in interpreting these results.

REC-4881's mechanism as a non-ATP-competitive allosteric MEK 1/2 inhibitor targeting the cellular effects of APC gene loss (the root cause of FAP) is scientifically sound. Recursion's approach of using AI to identify this application demonstrates a novel path to addressing genetic diseases through precision targeting of pathway dysregulation.

The Fast Track and Orphan Drug designations from regulatory agencies reflect the significant unmet need in this population of approximately 50,000 patients across major markets. The upcoming presentation at DDW in May will provide updated data from a more recent cutoff, offering better insight into durability and potentially expanded efficacy findings.

Biotechnology Investment Analyst

Early positive clinical data validates Recursion's AI platform in identifying novel therapeutic applications, addressing a rare disease with significant unmet need.

Recursion's presentation of preliminary REC-4881 data represents a significant milestone for their AI-powered drug discovery platform. The Recursion OS successfully identified MEK 1/2 inhibition as a potential treatment approach for FAP by analyzing cellular models of APC gene loss - demonstrating the platform's ability to uncover non-obvious therapeutic applications.

The market opportunity for FAP, while niche at approximately 50,000 patients across major markets, represents a commercially viable target given the complete absence of approved pharmacological interventions. Orphan drug pricing models typically support sustainable commercialization even with smaller patient populations.

Regulatory advantages are substantial, with Fast Track and dual Orphan Drug designations (FDA and European Commission) providing accelerated development pathways and extended market exclusivity upon approval. These designations significantly enhance the program's value proposition and development efficiency.

The acceptance of this data as a late-breaking oral presentation at DDW highlights the scientific community's interest in this approach. The presentation will include newer data beyond the February 7, 2025 cutoff cited in the abstract, potentially providing more robust evidence of efficacy.

For a clinical-stage TechBio company like Recursion, these early positive signals are particularly meaningful as they provide validation of their AI-driven discovery approach beyond just the specific therapeutic candidate. Success in this program could enhance confidence in their broader platform and pipeline.

Salt Lake City, UT, April 22, 2025 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, will present preliminary data during the 2025 Digestive Disease Week (DDW) meeting from its ongoing Phase 1b/2 clinical trial, TUPELO, which is evaluating the safety and preliminary activity of REC-4881 for the treatment of familial adenomatous polyposis (FAP). The data will be presented as a late-breaking oral presentation during the Research Forum session on Hereditary GI cancer syndromes on Sunday, May 4, 2025 in San Diego.

“We are pleased that DDW has recognized the importance of our data in addressing the unmet needs of the FAP patient population, where no FDA-approved therapies currently exist,” said Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer at Recursion. “MEK 1/2 inhibition for the potential treatment of FAP was identified through our AI-powered Recursion OS platform, which analyzed cellular models of APC gene loss to uncover a potential first-in-disease treatment. We look forward to sharing our preliminary findings in our upcoming DDW presentation in May.”

Currently, there are no FDA-approved therapies for FAP, a rare hereditary autosomal dominant colorectal cancer predisposition syndrome, affecting approximately 50,000 people in the US, France, Germany, Italy, Spain, and the UK. REC-4881 has been granted Fast Track and Orphan Drug designation by the U.S. Food and Drug Administration as well as Orphan Drug designation by the European Commission.

REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule MEK 1/2 inhibitor. The platform analyzed cellular models of APC gene loss—the root cause of FAP—to identify compounds that suppress the disease-inducing effects of APC mutations.

In the late-breaking abstract, Recursion presented preliminary data as of February 7, 2025, showing that 13 patients received 4 mg of REC-4881 QD, with 84.6% experiencing at least one treatment-related adverse event (TRAE). The most commonly reported TRAE was rash / dermatitis acneiform, primarily Grade 1 or 2. Of the 5 efficacy-evaluable patients, they experienced a greater than 30% median reduction in total polyp burden after 12 weeks of treatment. The DDW data presentation will include new results from a later data cut-off, as well as the data included in the accepted abstract.

For more information about Digestive Disease Week please visit https://www.ddw.org/.

Presentation Title: Ongoing Phase 1b/2 Trial of the Allosteric MEK1/2 Inhibitor REC-4881 as Monotherapy in Familial Adenomatous Polyposis (FAP): Preliminary Safety and Efficacy Data

Session 0006, Presentation ID 354a: May 4, 2025 from 9:15 AM to 9:30 AM PDT

Presenter: N Jewel Samadder, M.D., Mayo Clinic Comprehensive Cancer Center

About the TUPELO Trial 
The Phase 1b/2 TUPELO trial is evaluating REC-4881 as a potential treatment for patients with FAP post-colectomy/proctocolectomy. This multicenter, open-label study assesses the efficacy, safety, and pharmacokinetics of REC-4881 in this patient population.

About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements
This document contains information that includes or is based upon "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding the potential efficacy of REC-4881, including the potential to be a first-in-disease treatment; the timing of and outcomes of the TUPELO clinical trial; the effects of our platform on trial outcomes; the potential size of the market opportunity for our drug candidates; the timing and presentation of preliminary data at the 2025 Digestive Disease Week meeting; Recursion’s leadership of the TechBio space; the Recursion OS and other technologies; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

FAQ

What are the preliminary results of Recursion's (RXRX) REC-4881 Phase 1b/2 trial for FAP?

Preliminary data shows 5 efficacy-evaluable patients experienced >30% median reduction in polyp burden after 12 weeks, with 84.6% of 13 treated patients experiencing treatment-related adverse events, mainly mild to moderate rash.

How many patients are affected by FAP in Recursion's (RXRX) target markets?

FAP affects approximately 50,000 people across the United States, France, Germany, Italy, Spain, and the United Kingdom.

What regulatory designations has Recursion's (RXRX) REC-4881 received?

REC-4881 has received Fast Track and Orphan Drug designation from the FDA, and Orphan Drug designation from the European Commission.

When will Recursion (RXRX) present the REC-4881 trial data at DDW 2025?

Recursion will present the data on May 4, 2025, from 9:15 AM to 9:30 AM PDT in San Diego.

What is the dosage of REC-4881 being tested in Recursion's (RXRX) FAP trial?

The trial is testing a 4 mg daily (QD) dose of REC-4881.