– The global THRIVE Phase 3 trial will be conducted in approximately 50 centers across North America and Europe –
– Topline results for the THRIVE Phase 3 trial are expected in the middle of 2024 –
WALTHAM, MA, USA I December 21, 2022 I Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that the first patient has been enrolled in its THRIVE Phase 3 trial evaluating the efficacy and safety of the investigational agent VRDN-001 in patients with active thyroid eye disease (TED). The global THRIVE Phase 3 trial will be conducted in approximately 50 centers across North America and Europe.
“We are pleased to enroll the first patient in the THRIVE trial, which is designed to confirm the compelling early results we’ve seen in TED patients,” said Jonathan Violin, Ph.D., President and Chief Executive Officer of Viridian Therapeutics. “The study is a significant milestone for Viridian, and reinforces our commitment to the TED community. It is an important and meaningful step in our efforts to provide new and improved treatment options to patients with TED.”
The THRIVE Phase 3 trial is a double-blind, placebo-controlled, randomized study enrolling approximately 120 patients with active TED. The study participants will be randomized 1:1:1 across three arms: VRDN-001 10 milligrams per kilogram administered once every three weeks for eight cycles, an accelerated course of VRDN-001 10 milligrams per kilogram administered once every three weeks for five cycles, and a placebo arm.
The primary efficacy endpoint for THRIVE is proptosis (eye bulging) responder rate, defined as the proportion of patients who achieve a reduction of proptosis of at least 2 millimeters compared to baseline at week 24. Secondary endpoints include overall response rate, change in proptosis as measured by exophthalmometer and magnetic resonance imaging (MRI), change in clinical activity score, and rate of diplopia resolution. Following week 24, trial participants may roll over into an open-label extension study followed by a longer-term registry study.
The Company is also planning a second global Phase 3 trial in patients with chronic TED called THRIVE-2. The THRIVE and THRIVE-2 Phase 3 trials will support global health authority registration for marketing approval in both active and chronic TED.
VRDN-001 is an investigational therapy not approved for any use in any country.
About Viridian’s Thyroid Eye Disease Pipeline (VRDN-001, -002, and -003)
Viridian’s lead product candidate, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease (TED). In preclinical studies, VRDN-001 was shown to be a full antagonist of IGF-1R, with more complete receptor blockade than other anti-IGF-1R antibodies, including the only currently approved TED therapy. Data from the initial dose cohorts of the Phase 2 portion of the ongoing trial established clinical proof-of-concept for VRDN-001 in patients with active TED. Preliminary data from the ongoing trial showed treatment with VRDN-001 led to reductions in proptosis, clinical activity score (CAS), and diplopia resolution. VRDN-001 was generally safe and well tolerated in the trial. The Company recently initiated its THRIVE Phase 3 trial in patients with active TED to support global marketing registration.
VRDN-001 is also being evaluated in Phase 2 trial cohorts in patients with chronic TED. Pending positive results, the Company plans to start its THRIVE-2 Phase 3 trial in patients with chronic TED.
The Company is also advancing VRDN-002, a distinct anti-IGF-1R antibody incorporating half-life extension technology, and VRDN-003, a half-life extended version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for administration as convenient, low-volume, subcutaneous injections.
VRDN-001, -002, and -003 are investigational therapies that are not approved for any use in any country.
About TED
TED is a serious and debilitating rare autoimmune disease that causes inflammation within the orbit of the eye that can cause double vision, pain, and potential blindness. TED is a progressive disease consisting of an initial active phase, followed by a transition to a secondary chronic phase. More than 50,000 and 200,000 people are estimated to suffer from active and chronic TED, respectively, in the United States and Europe.
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company recently initiated its first global Phase 3 trial called ‘THRIVE’ to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is also evaluating VRDN-001 in a Phase 2 proof-of-concept trial in patients with chronic TED. In addition to its intravenously administered VRDN-001 program, the Company is advancing two candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is developing multiple preclinical assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more information, please visit https://www.viridiantherapeutics.com. Follow Viridian on LinkedIn.
SOURCE: Viridian Therapeutics
Post Views: 138
– The global THRIVE Phase 3 trial will be conducted in approximately 50 centers across North America and Europe –
– Topline results for the THRIVE Phase 3 trial are expected in the middle of 2024 –
WALTHAM, MA, USA I December 21, 2022 I Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that the first patient has been enrolled in its THRIVE Phase 3 trial evaluating the efficacy and safety of the investigational agent VRDN-001 in patients with active thyroid eye disease (TED). The global THRIVE Phase 3 trial will be conducted in approximately 50 centers across North America and Europe.
“We are pleased to enroll the first patient in the THRIVE trial, which is designed to confirm the compelling early results we’ve seen in TED patients,” said Jonathan Violin, Ph.D., President and Chief Executive Officer of Viridian Therapeutics. “The study is a significant milestone for Viridian, and reinforces our commitment to the TED community. It is an important and meaningful step in our efforts to provide new and improved treatment options to patients with TED.”
The THRIVE Phase 3 trial is a double-blind, placebo-controlled, randomized study enrolling approximately 120 patients with active TED. The study participants will be randomized 1:1:1 across three arms: VRDN-001 10 milligrams per kilogram administered once every three weeks for eight cycles, an accelerated course of VRDN-001 10 milligrams per kilogram administered once every three weeks for five cycles, and a placebo arm.
The primary efficacy endpoint for THRIVE is proptosis (eye bulging) responder rate, defined as the proportion of patients who achieve a reduction of proptosis of at least 2 millimeters compared to baseline at week 24. Secondary endpoints include overall response rate, change in proptosis as measured by exophthalmometer and magnetic resonance imaging (MRI), change in clinical activity score, and rate of diplopia resolution. Following week 24, trial participants may roll over into an open-label extension study followed by a longer-term registry study.
The Company is also planning a second global Phase 3 trial in patients with chronic TED called THRIVE-2. The THRIVE and THRIVE-2 Phase 3 trials will support global health authority registration for marketing approval in both active and chronic TED.
VRDN-001 is an investigational therapy not approved for any use in any country.
About Viridian’s Thyroid Eye Disease Pipeline (VRDN-001, -002, and -003)
Viridian’s lead product candidate, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease (TED). In preclinical studies, VRDN-001 was shown to be a full antagonist of IGF-1R, with more complete receptor blockade than other anti-IGF-1R antibodies, including the only currently approved TED therapy. Data from the initial dose cohorts of the Phase 2 portion of the ongoing trial established clinical proof-of-concept for VRDN-001 in patients with active TED. Preliminary data from the ongoing trial showed treatment with VRDN-001 led to reductions in proptosis, clinical activity score (CAS), and diplopia resolution. VRDN-001 was generally safe and well tolerated in the trial. The Company recently initiated its THRIVE Phase 3 trial in patients with active TED to support global marketing registration.
VRDN-001 is also being evaluated in Phase 2 trial cohorts in patients with chronic TED. Pending positive results, the Company plans to start its THRIVE-2 Phase 3 trial in patients with chronic TED.
The Company is also advancing VRDN-002, a distinct anti-IGF-1R antibody incorporating half-life extension technology, and VRDN-003, a half-life extended version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for administration as convenient, low-volume, subcutaneous injections.
VRDN-001, -002, and -003 are investigational therapies that are not approved for any use in any country.
About TED
TED is a serious and debilitating rare autoimmune disease that causes inflammation within the orbit of the eye that can cause double vision, pain, and potential blindness. TED is a progressive disease consisting of an initial active phase, followed by a transition to a secondary chronic phase. More than 50,000 and 200,000 people are estimated to suffer from active and chronic TED, respectively, in the United States and Europe.
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The Company recently initiated its first global Phase 3 trial called ‘THRIVE’ to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is also evaluating VRDN-001 in a Phase 2 proof-of-concept trial in patients with chronic TED. In addition to its intravenously administered VRDN-001 program, the Company is advancing two candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is developing multiple preclinical assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more information, please visit https://www.viridiantherapeutics.com. Follow Viridian on LinkedIn.
SOURCE: Viridian Therapeutics
Post Views: 138
