Viridian Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure
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| Item 7.01 | Regulation FD Disclosure. |
On December 16, 2024, Viridian Therapeutics, Inc. (the “Company”) issued a press release announcing topline data from a phase 3 randomized trial of veligrotug (formerly VRDN-001), a differentiated humanized monoclonal antibody targeting IGF-1R, in patients with chronic thyroid eye disease (“TED”), which the Company refers to as the THRIVE-2 trial.
A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, regardless of any general incorporation language in such filing.
| Item 8.01 | Other Events. |
On December 16, 2024, the Company announced topline data from the THRIVE-2 trial. The following summarizes the data and other clinical updates.
THRIVE-2 Phase 3 Topline Results
THRIVE-2 Clinical Activity Data
THRIVE-2 met all primary and secondary endpoints at the 15-week primary analysis timepoint after five infusions of veligrotug, showing statistically significant responses on all of the measured signs and symptoms of TED: proptosis, clinical activity score (“CAS”), and diplopia. THRIVE-2 enrolled a total of 188 patients, randomized to veligrotug (n = 125) and placebo (n = 63). The mean time since onset of TED in this patient population was 69.8 months.
The key data at the primary efficacy analysis timepoint of 15 weeks are as follows:
Proptosis:
| • | Proptosis Responder Rate (“PRR”): 56% in veligrotug patients, compared with 8% in placebo patients (48% placebo-adjusted, p < 0.0001). PRR was statistically significant at all time points, including as early as three weeks after just one infusion, demonstrating a rapid onset of response. PRR is defined as at least a 2-millimeter (mm) reduction in proptosis from baseline in the study eye without worsening in the fellow eye (≥2 mm increase), as measured by exophthalmometry. PRR results as measured by MRI/CT were consistent with those measured by exophthalmometry at the primary efficacy analysis timepoint. For patients treated with veligrotug, PRR at each measured time point was: 25%, 40%, 50%, 54%, and 56% (at weeks 3, 6, 9, 12, and 15, respectively). PRR for patients receiving placebo ranged from 8-13% across the time points. |
| • | Proptosis Mean Reduction: 2.34mm mean reduction in proptosis from baseline in veligrotug patients, compared with 0.46mm reduction in placebo patients (1.9mm placebo-adjusted, p < 0.0001). Patients receiving veligrotug had a mean change in proptosis from baseline of -1.06, -1.70, -2.04, -2.22, and -2.34 mm (at weeks 3, 6, 9, 12, and 15, respectively). Mean change in proptosis for patients receiving placebo was -0.46 mm to -0.75 mm across time points. Proptosis Mean Reduction was statistically significant at all time points. |
Diplopia:
| • | Diplopia Response: 56% of veligrotug patients achieved a diplopia response, compared with 25% of placebo patients (31% placebo-adjusted, p = 0.0006). Rapid onset observed as early as six weeks after just two infusions. Diplopia response is defined as patients achieving a reduction of at least 1 on the Gorman subjective diplopia scale at week 15, for those patients with diplopia at baseline (n = 102). Patients receiving veligrotug had a diplopia responder rate at a rate of 29%, 47%, 52%, 55%, and 56% (at weeks 3, 6, 9, 12, and 15, respectively). Diplopia responder rate for patients receiving placebo ranged from 14-25% across the time points. |
| • | Diplopia Complete Resolution: 32% of veligrotug patients achieved complete resolution of diplopia, compared with 14% of placebo patients (18% placebo-adjusted, p = 0.0152). Rapid onset observed as early as six weeks after just two infusions. Diplopia resolution is defined as patients achieving a score of 0 on the Gorman subjective diplopia scale at week 15, for those patients with diplopia at baseline. Patients receiving veligrotug had diplopia complete resolution at a rate of 18%, 31%, 36%, 33%, and 32% (at weeks 3, 6, 9, 12, and 15, respectively). Diplopia complete resolution for patients receiving placebo ranged from 5-14% across the time points. |
Clinical Activity Score:
CAS measures inflammatory signs and symptoms of TED, providing a composite score of pain, as well as redness and swelling of the eyelids and conjunctiva, on a scale from 0 to 7.
| • | CAS Reduction to 0 or 1: 54% of veligrotug patients achieved maximal or near-maximal therapeutic effect on CAS, compared with 24% of placebo patients (29% placebo-adjusted, p = 0.006), defined as reaching a CAS of 0 or 1, among patients with a CAS of ≥ 3 at baseline (n = 104). |
| • | CAS Mean Reduction: 2.9-point mean reduction in CAS from baseline in veligrotug patients, compared with 1.3-point reduction in placebo patients (1.6-point placebo-adjusted, p < 0.0001), among patients with a CAS of ≥ 3 at baseline. |
Overall Response:
| • | Overall Responder Rate: 56% of veligrotug patients achieved an overall response, compared with 7% of placebo patients (50% placebo-adjusted, p < 0.0001). Overall Responder Rate is defined as achieving a proptosis response without worsening of CAS from baseline (≥ 1 point increase) and without worsening in the fellow eye in either proptosis (2mm increase) or CAS. |
THRIVE-2 Safety Data
| • | Generally Well-Tolerated: Veligrotug was generally well-tolerated with a safety profile consistent with previous veligrotug studies including THRIVE. The majority of adverse events (AEs) were mild, and 94% of veligrotug-treated patients completed their treatment course. The AEs occurring at greater than or equal to 10% frequency in either arm were (veligrotug vs. placebo): muscle spasms (36% vs. 6%), headache (14% vs. 13%), hearing impairment (13% vs. 3%), fatigue (12% vs. 8%), diarrhea (11% vs. 10%), hyperglycemia (10% vs. 5%), and menstrual disorders (33% vs. 10%, of menstruating women in the trial). |
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits.
| Exhibit Number |
Exhibit Description | |
| 99.1 | Press release, dated December 16, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Viridian Therapeutics, Inc. | ||||||
| Date: December 16, 2024 | By: | /s/ Stephen Mahoney | ||||
| Stephen Mahoney | ||||||
| President, Chief Executive Officer, and Director | ||||||