~360K1
UPDATE: Recursion Announces Phase 2 Data of REC-994, a First-in-Disease Investigational Treatment for Symptomatic Cerebral Cavernous Malformation (CCM), has Met its Primary Endpoint of Safety and Tolerability. Read more.
REC-994 is an orally bioavailable small molecule superoxide scavenger being developed for the treatment of CCM. CCM is a devastating neurovascular disease with approximately 360,000 symptomatic patients in the US, France, Germany, Italy, Spain and the UK. In Phase 1 trials in healthy volunteers that Recursion conducted, REC-994 demonstrated tolerability and suitability for chronic dosing.
In March 2022, we announced the initiation of our Phase 2 SYCAMORE clinical trial, which is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of REC-994 in participants with CCM. This study was fully enrolled as of June 2023 with 62 participants and all participants who have thus far finished their first year of treatment have enrolled in the long-term extension study. We expect to share Phase 2 topline data in the third quarter of 2024.
Learn more on clinicaltrials.gov.
~33K2
REC-2282 is a CNS-penetrant, orally bioavailable, small molecule pan-HDAC inhibitor being developed for the treatment of NF2-mutated meningiomas. There are currently no FDA-approved drugs for the treatment of patients with NF2, an inherited genetic syndrome that can cause a variety of benign tumors in the central nervous system, including meningiomas. This molecule appears to be well tolerated, including in patients dosed for multiple years, and potentially has reduced cardiac toxicity that would differentiate it from other HDAC inhibitors. Its oral bioavailability and CNS penetrance distinguish it from currently-approved HDAC inhibitors.
In June 2022, we announced the initiation of our Phase 2/3 POPLAR clinical trial, which is a two part study of REC-2282 in participants with progressive NF2-mutated meningiomas. Part A of the study is ongoing and is exploring two doses of REC-2282 in approximately 23 adults and 9 adolescents. We expect to share Phase 2 safety, tolerability, pharmacokinetics, and preliminary efficacy data in the fourth quarter of 2024.
Learn more on clinicaltrials.gov.
~50K3
REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in people living with FAP. There are currently no FDA-approved therapies for the treatment of FAP, a rare tumor predisposition syndrome affecting approximately 50,000 people in the US, France, Germany, Italy, Spain and the UK.
In September 2022, we announced the initiation of our Phase 2 TUPELO clinical trial, which is a multicenter, randomized, double-blind, placebo-controlled two-part clinical trial to evaluate efficacy, safety, and pharmacokinetics of REC-4881 in patients with FAP. We have enrolled multiple participants and expect to share Phase 2 safety, tolerability, pharmacokinetics, and preliminary efficacy data in the first half of 2025.
Learn more on clinicaltrials.gov.
~730K
REC-3964 represents a novel small molecule approach designed to selectively inhibit the toxin produced by Clostridioides difficile in the gastrointestinal tract. This molecule has the potential, when used as part of a treatment regimen, to prevent recurrent disease and/or other forms of C. diff infection, which is a leading cause of antibiotic-induced diarrhea sometimes leading to significant morbidity and mortality. More than 29,000 patients die in the US every year from C. diff infection.
In September 2023, we announced the completion of our Phase 1 clinical trial, which achieved its primary objectives of assessing the safety, tolerability and pharmacokinetic profile of REC-3964. REC-3964 was well tolerated with no serious adverse events reported. Based on these data, a Phase 2 proof-of-concept trial is expected to initiate in 2024 to further study the attributes of this molecule.
~50K4,5,6
This program originated under our initial fibrosis collaboration with Bayer and we have since in-licensed from Bayer all rights to this program. We are advancing our lead candidate through IND-enabling studies with IND submission expected in the near-term.
~104K7
In October 2022, we announced the nomination of REC-4881 for the potential treatment of advanced AXIN1/APC mutant cancers. We will evaluate REC-4881 in a Phase 2 biomarker enriched study in patients with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. This study was initiated at the end of 2023 with the first participant dosed in Q1 2024. Since that time, multiple participants are now enrolled. We expect to share Phase 2 safety and preliminary efficacy data in the first half of 2025.
Learn more on clinicaltrials.gov.
REC-1245 (previously identified as Target γ) targets RBM39, a novel CDK12-adjacent target identified by the Recursion OS. We believe we can modulate this target to produce a therapeutic effect in biomarker-enriched solid tumors and lymphoma. This program is in the preclinical stage and IND-enabling studies are progressing. The FDA has cleared an IND application for a Phase 1/2 clinical trial of REC-1245. Read more.
~360K1
UPDATE: Recursion Announces Phase 2 Data of REC-994, a First-in-Disease Investigational Treatment for Symptomatic Cerebral Cavernous Malformation (CCM), has Met its Primary Endpoint of Safety and Tolerability. Read more.
REC-994 is an orally bioavailable small molecule superoxide scavenger being developed for the treatment of CCM. CCM is a devastating neurovascular disease with approximately 360,000 symptomatic patients in the US, France, Germany, Italy, Spain and the UK. In Phase 1 trials in healthy volunteers that Recursion conducted, REC-994 demonstrated tolerability and suitability for chronic dosing.
In March 2022, we announced the initiation of our Phase 2 SYCAMORE clinical trial, which is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of REC-994 in participants with CCM. This study was fully enrolled as of June 2023 with 62 participants and all participants who have thus far finished their first year of treatment have enrolled in the long-term extension study. We expect to share Phase 2 topline data in the third quarter of 2024.
Learn more on clinicaltrials.gov.
~33K2
REC-2282 is a CNS-penetrant, orally bioavailable, small molecule pan-HDAC inhibitor being developed for the treatment of NF2-mutated meningiomas. There are currently no FDA-approved drugs for the treatment of patients with NF2, an inherited genetic syndrome that can cause a variety of benign tumors in the central nervous system, including meningiomas. This molecule appears to be well tolerated, including in patients dosed for multiple years, and potentially has reduced cardiac toxicity that would differentiate it from other HDAC inhibitors. Its oral bioavailability and CNS penetrance distinguish it from currently-approved HDAC inhibitors.
In June 2022, we announced the initiation of our Phase 2/3 POPLAR clinical trial, which is a two part study of REC-2282 in participants with progressive NF2-mutated meningiomas. Part A of the study is ongoing and is exploring two doses of REC-2282 in approximately 23 adults and 9 adolescents. We expect to share Phase 2 safety, tolerability, pharmacokinetics, and preliminary efficacy data in the fourth quarter of 2024.
Learn more on clinicaltrials.gov.
~50K3
REC-4881 is an orally bioavailable, non-ATP-competitive allosteric small molecule inhibitor of MEK1 and MEK2 being developed to reduce polyp burden and progression to adenocarcinoma in people living with FAP. There are currently no FDA-approved therapies for the treatment of FAP, a rare tumor predisposition syndrome affecting approximately 50,000 people in the US, France, Germany, Italy, Spain and the UK.
In September 2022, we announced the initiation of our Phase 2 TUPELO clinical trial, which is a multicenter, randomized, double-blind, placebo-controlled two-part clinical trial to evaluate efficacy, safety, and pharmacokinetics of REC-4881 in patients with FAP. We have enrolled multiple participants and expect to share Phase 2 safety, tolerability, pharmacokinetics, and preliminary efficacy data in the first half of 2025.
Learn more on clinicaltrials.gov.
~730K
REC-3964 represents a novel small molecule approach designed to selectively inhibit the toxin produced by Clostridioides difficile in the gastrointestinal tract. This molecule has the potential, when used as part of a treatment regimen, to prevent recurrent disease and/or other forms of C. diff infection, which is a leading cause of antibiotic-induced diarrhea sometimes leading to significant morbidity and mortality. More than 29,000 patients die in the US every year from C. diff infection.
In September 2023, we announced the completion of our Phase 1 clinical trial, which achieved its primary objectives of assessing the safety, tolerability and pharmacokinetic profile of REC-3964. REC-3964 was well tolerated with no serious adverse events reported. Based on these data, a Phase 2 proof-of-concept trial is expected to initiate in 2024 to further study the attributes of this molecule.
~50K4,5,6
This program originated under our initial fibrosis collaboration with Bayer and we have since in-licensed from Bayer all rights to this program. We are advancing our lead candidate through IND-enabling studies with IND submission expected in the near-term.
~104K7
In October 2022, we announced the nomination of REC-4881 for the potential treatment of advanced AXIN1/APC mutant cancers. We will evaluate REC-4881 in a Phase 2 biomarker enriched study in patients with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. This study was initiated at the end of 2023 with the first participant dosed in Q1 2024. Since that time, multiple participants are now enrolled. We expect to share Phase 2 safety and preliminary efficacy data in the first half of 2025.
Learn more on clinicaltrials.gov.
At Recursion Pharmaceuticals, we are committed to radically improving the lives of patients and their families by developing therapies that will make a lasting, positive, and transformative impact on diseases and conditions for which there are high unmet needs.
We believe that the best way to succeed in our mission is through well-designed clinical trials that determine the safety and effectiveness of investigational medicines. We understand that in some rare and specific circumstances, when enrollment into a clinical trial is not possible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines. When appropriate and through an expanded access protocol, Recursion will consider individual Expanded Access, sometimes called “Compassionate Use” or “Early Access”, requests for an investigational medicine outside of an ongoing clinical trial for the indication being investigated by the company.
There may be additional requirements, but to start, a licensed treating physician must submit the request for Expanded Access in writing by contacting ExpandedAccess@Recursion.com. The physician must be able and willing to obtain a treatment IND, or regional equivalent, and Institutional Review Board or Ethics Committee approval, for the patient prior to initiating treatment with our investigational medicine.
We will consider applications to provide the investigational drug that will not, among other things, compromise the scientific validity of our broader development programs, or interfere with or delay clinical trials or regulatory filings designed to make the drug available to a larger patient population.
We endeavor to respond to Expanded Access requests within one week after the steps for submission are completed.
It is important to remember that investigational medicinal products have not yet received regulatory approval; thus, their potential risks and benefits are not yet established. Physicians and patients should consider all possible benefits and risks when seeking access to an investigational medicinal product. For information on available clinical trials visit: www.ClinicalTrials.gov.
Recursion is committed to maintaining the highest level of integrity and ethics across all clinical trials and investigational programs, including the timely and transparent disclosure of clinical trial information and results.
All company-sponsored Phase 2 and 3 clinical trials are posted on country-specific registries of clinical trials, such as clinicaltrials.gov. As part of our commitment to advancing science in the therapeutic areas in which we work, Recursion discloses results of these trials on public registries within 12 months following the trial completion date. To keep our patients informed, clinical trial results will be made available to participants in that trial upon request. Additionally, Recursion aims to submit an abstract of the primary analysis of clinical trial results for publication regardless of trial outcome or regulatory approval status.
By leveraging technology at every step of the process, we can accelerate the development of high potential drug candidates once we have validated their potential.