| Item 7.01 | Regulation FD Disclosure. |
On November 20, 2024, NewAmsterdam Pharma Company N.V. (the “Company”) issued a press release announcing positive topline data from its Phase 3 TANDEM clinical trial evaluating the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg in adult patients with heterozygous familial hypercholesterolemia (“HeFH”) and/or atherosclerotic cardiovascular disease (“ASCVD”) or multiple ASCVD risk factors, whose low-density lipoprotein cholesterol (“LDL-C”) is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The Company is hosting a live webcast and conference call to discuss the positive topline results of the TANDEM clinical trial on November 20, 2024 at 8:00 a.m., Eastern Time, and a live webcast of the call will be available through the Company’s website. A copy of the slide presentation to be used by the Company during the conference call is attached hereto as Exhibit 99.2 and incorporated herein by reference.
The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise expressly stated in any such filing.
On November 20, 2024, the Company announced topline data from its TANDEM clinical trial, a Phase 3, randomized, double-blind, four-arm, placebo-controlled multicenter study evaluating the effect of 10 mg obicetrapib and 10 mg ezetimibe as a fixed-dose combination on LDL-C levels, compared to both ezetimibe 10 mg and obicetrapib 10 mg monotherapy and to placebo. The co-primary endpoints were percent change from baseline in LDL-C of the fixed-dose combination compared to each monotherapy arm after 84 days and obicetrapib 10 mg compared to placebo after day 84. Secondary endpoints incorporated percent changes from baseline in other biomarkers, including lipoprotein(a), non-high-density lipoprotein cholesterol and apolipoprotein B.
The TANDEM trial met all co-primary endpoints, including the obicetrapib-ezetimibe fixed dose combination achieving an LS mean reduction of 48.6% (p < 0.0001) compared to placebo at day 84. The observed reductions in the other co-primary endpoints are summarized below.
LDL-C percentage change:
| | | | | | | | | | | | |
| | | Ezetimibe
(n=101) | | | Obicetrapib
(n=102) | | | Obicetrapib and
Ezetimibe FDC
(n=102) | |
Day 84 - from placebo | | | | | | | | | | | | |
Mean % | | | -23.3 | | | | -35.5 | | | | -52.2 | |
Median % | | | -22.6 | | | | -37.2 | | | | -54.0 | |
LS mean % | | | -20.7 | | | | -31.9 | | | | -48.6 | |
Comparison to pbo | | | — | | | | (p<0.0001) | | | | (p<0.0001) | |
Comparison to eze 10 mg | | | — | | | | — | | | | (p<0.0001) | |
Comparison to obi 10 mg | | | — | | | | — | | | | (p=0.0007) | |
We also observed reductions in lipoprotein(a), with mean observed reduction compared of placebo of 16.2% in the ezetimibe monotherapy arm, 56.2% in the obicetrapib monotherapy arm and 62.9% in the fixed-dose combination arm.
Over 60% of patients in the fixed-dose combination group saw a greater than 50% decrease in LDL-C levels. In the fixed-dose combination group, approximately 71%, 80% and 90% of patients achieved LDL-C levels of less than 55 mg/dl, 70 mg/dl and 100 mg dl, respectively. Similar LDL-C levels were achieved by approximately 41%, 60% and 88% of patients in the obicetrapib 10 mg group, respectively, approximately 25%, 56% and 80% of patients in the ezetimibe group, respectively, and approximately 7%, 18% and 64% of patients in the placebo group, respectively.
