Flexion To Test Higher Dose Of FX201 Gene Therapy In Early-Stage Osteoarthritis Study

Flexion Therapeutics Inc (NASDAQ: FLXN) plans to advance FX201 into the high dose cohort of Phase 1 dose-escalation trial, evaluating the safety and tolerability of FX201 for the treatment of osteoarthritis (OA).
The decision follows an independent Data Monitoring Committee (DMC) review of the mid-dose safety data.
The company also announced to expand the trial to include up to 20 additional patients in both the low and mid-dose treatment groups.
Data from the single ascending dose phase of this study indicated that the low and mid doses of FX201 appear to be well tolerated. No serious adverse events and evidence of systemic biodistribution in plasma or shedding in urine were observed in any patient.
Longer-term data to assess the safety and clinical activity in both the low and mid-dose cohorts are still being collected. Interim data will be presented at a scientific meeting in the first half of 2021.
Data through Week 52 for patients treated in the initial low and mid-dose cohorts of the single ascending dose phase are expected by the end of 2021. Besides, preliminary data from the high dose cohort and expanded treatment groups are also anticipated before year-end.
Price Action: FLXN stock is down 1.58% at $11.23 in market trading hours on last check Thursday.