REC-994

Recursion's Phase 2 Clinical Trial

REC-994 is being developed by Recursion Pharmaceuticals specifically for the treatment of cerebral cavernous malformations.

The Phase I trial of REC-994, using healthy volunteers, was completed in late 2020. A Phase II trial testing the safety and tolerability of the medicine in patients with CCM is launching in early 2022. The Phase 2 trial will include 60 patients who will be randomized into three groups: a high-dose group, a low-dow group, and a placebo group. The patient eligibility criteria for the trial are below. Please check clinicaltrials.gov often to learn about United States trial sites as they open.

REC-994 is the first industry-sponsored trial of a medicine developed specifically for CCM.  The following webinar offers more information about its unique history.

Phase 2 Trial

Eligibility Criteria (from Clinicaltrials.gov NCT05085561)

Ages Eligible for Study: 18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion criteria:
  1. 18 years of age or older with anatomic CCM lesions demonstrated by brain MRI
  2. Have symptomatic CCM
  3. Have provided written informed consent to participate in the study
  4. Have NOT participated in a clinical trial utilizing an investigational agent within 28 days or within 6 half-lives of the investigational drug (whichever is longer) prior to Screening

Exclusion Criteria:

  1. Symptoms deemed by the study Investigator to be caused exclusively by irreversible neuronal damage from prior stroke or neurosurgical instrumentation
  2. History of cranial irradiation or surgical/radiosurgical treatment of the primary symptomatic CCM lesion
  3. Pregnant or breast feeding
  4. Unable or unwilling to participate in MRI assessments (eg, claustrophobia, metal implant, implanted cardiac pacemaker, allergy to gadolinium)
  5. Liver dysfunction or active liver disease as defined by baseline serum transaminases >2x upper limit of normal (ULN)
  6. Have severely impaired renal function (eGFR <60ml/min) or active renal disease
  7. Have had a previous diagnosis of skeletal muscle disorders (myopathy) of any cause or have a baseline creatine kinase level > 5x ULN
  8. History of alcohol or substance abuse within 1 year prior to screening
  9. Clinically significant laboratory abnormality
  10. Have had an intracerebral hemorrhage within 3 months of screening or any brain surgery within 6 months of screening

 

Updated 12.20.2021