- Findings from a Phase 1 single ascending dose trial indicate the low dose of FX201, an intra-articular gene therapy candidate for osteoarthritis (OA), was generally well-tolerated
- Two of five patients (40%) treated with FX201 in the low-dose, single ascending dose cohort reported substantial improvement in pain out to Week 24
- No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient
- Longer term follow-up data from the low-dose cohort will be presented at ASGCT on May 11
BURLINGTON, MA, USA I April 28, 2021 I Flexion Therapeutics, Inc. (Nasdaq:FLXN) will present preliminary data from a Phase 1 single ascending dose (SAD) trial of FX201 at the 2021 American Society of Gene & Cell Therapy (ASGCT) annual meeting taking place virtually May 11-14, 2021.
“We are pleased to share preliminary clinical data from our FX201 single ascending dose trial at the American Society of Gene & Cell Therapy annual meeting,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “While the Phase 1 SAD study is principally designed to evaluate the safety and tolerability of FX201, it is encouraging to see an early signal of clinical activity in the low-dose cohort with two of the five patients treated reporting substantial pain relief that lasted through at least Week 24. We look forward to providing updated data from this cohort at ASGCT on May 11.”
The clinical data will be presented in a digital presentation entitled, Interim Data from the First-in-Human Phase 1 Trial of FX201, An Intra-Articular, Helper-Dependent Adenoviral Gene Therapy for Osteoarthritis – Safety, Tolerability, Biodistribution, and Preliminary Evaluation of Clinical Activity in 5 Patients (Abstract 594). Key findings included in the ASCGT abstract:
- FX201 was generally well-tolerated in the initial low-dose cohort.
- Two patients had self-limited Grade 2 index-knee AEs (pain, swelling, effusion) possibly related to treatment, managed conservatively.
- No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient, indicating that the vector remained in the encapsulated joint space.
- Based on IMMPACT1 criteria, two out of the five patients (40%) demonstrated substantial improvement in knee OA pain at Weeks 8, 12, and 24 following treatment with FX201.
Flexion will present longer term follow-up data from the low-dose cohort in a video presentation available on the ASGCT website at the start of the conference on May 11.
About FX201
FX201 is an investigational gene therapy which utilizes a helper-dependent adenovirus (HDAd) vector devoid of all viral genes that carries a coding sequence for an anti-inflammatory protein called interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-responsive promoter. FX201 is injected directly into the joint space (also termed the intra-articular space) and is intended to deliver as-needed anti-inflammatory activity to joint tissues, with the goal of providing at least 6 to 12 months of meaningful pain relief and functional improvement following a single injection with the possibility of slowing disease progression.
About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, the most common form of arthritis. The company’s core values are focus, ingenuity, tenacity, transparency, and fun. Please visit flexiontherapeutics.com.
SOURCE: Flexion Therapeutics
Post Views: 26
- Findings from a Phase 1 single ascending dose trial indicate the low dose of FX201, an intra-articular gene therapy candidate for osteoarthritis (OA), was generally well-tolerated
- Two of five patients (40%) treated with FX201 in the low-dose, single ascending dose cohort reported substantial improvement in pain out to Week 24
- No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient
- Longer term follow-up data from the low-dose cohort will be presented at ASGCT on May 11
BURLINGTON, MA, USA I April 28, 2021 I Flexion Therapeutics, Inc. (Nasdaq:FLXN) will present preliminary data from a Phase 1 single ascending dose (SAD) trial of FX201 at the 2021 American Society of Gene & Cell Therapy (ASGCT) annual meeting taking place virtually May 11-14, 2021.
“We are pleased to share preliminary clinical data from our FX201 single ascending dose trial at the American Society of Gene & Cell Therapy annual meeting,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “While the Phase 1 SAD study is principally designed to evaluate the safety and tolerability of FX201, it is encouraging to see an early signal of clinical activity in the low-dose cohort with two of the five patients treated reporting substantial pain relief that lasted through at least Week 24. We look forward to providing updated data from this cohort at ASGCT on May 11.”
The clinical data will be presented in a digital presentation entitled, Interim Data from the First-in-Human Phase 1 Trial of FX201, An Intra-Articular, Helper-Dependent Adenoviral Gene Therapy for Osteoarthritis – Safety, Tolerability, Biodistribution, and Preliminary Evaluation of Clinical Activity in 5 Patients (Abstract 594). Key findings included in the ASCGT abstract:
- FX201 was generally well-tolerated in the initial low-dose cohort.
- Two patients had self-limited Grade 2 index-knee AEs (pain, swelling, effusion) possibly related to treatment, managed conservatively.
- No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or at the injection site was observed in any patient, indicating that the vector remained in the encapsulated joint space.
- Based on IMMPACT1 criteria, two out of the five patients (40%) demonstrated substantial improvement in knee OA pain at Weeks 8, 12, and 24 following treatment with FX201.
Flexion will present longer term follow-up data from the low-dose cohort in a video presentation available on the ASGCT website at the start of the conference on May 11.
About FX201
FX201 is an investigational gene therapy which utilizes a helper-dependent adenovirus (HDAd) vector devoid of all viral genes that carries a coding sequence for an anti-inflammatory protein called interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-responsive promoter. FX201 is injected directly into the joint space (also termed the intra-articular space) and is intended to deliver as-needed anti-inflammatory activity to joint tissues, with the goal of providing at least 6 to 12 months of meaningful pain relief and functional improvement following a single injection with the possibility of slowing disease progression.
About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, the most common form of arthritis. The company’s core values are focus, ingenuity, tenacity, transparency, and fun. Please visit flexiontherapeutics.com.
SOURCE: Flexion Therapeutics
Post Views: 26
