Rhythm Pharmaceuticals Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
On April 7, 2025, Rhythm Pharmaceuticals, Inc. (“Rhythm”) issued a press release and published a corporate presentation announcing topline results from its Phase 3 TRANSCEND clinical trial evaluating setmelanotide in patients with acquired hypothalamic obesity, which are summarized under Item 8.01 below. The presentation is available in the “Events & Presentations” portion of the Company's website at ir.rhythmtx.com. A copy of the press release and presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report (including Exhibits 99.1 and 99.2 attached hereto) 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 liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.
Item 8.01. Other Events
On April 7, 2025, Rhythm announced topline results from its Phase 3 TRANSCEND clinical trial evaluating setmelanotide in patients with acquired hypothalamic obesity, which are summarized below.
The global trial met its primary endpoint with a highly statistically significant and clinically meaningful reduction in body mass index (BMI) with setmelanotide in both adult and pediatric patients versus placebo.
Highlights from the top-line data include:
• | -19.8% placebo-adjusted difference in BMI reduction (N=120), and primary endpoint of mean BMI reduction of -16.5% from baseline for all patients on setmelanotide therapy (n=81) compared with +3.3% BMI change for patients on placebo (n=39) at 52 weeks (p<0.0001); |
| - | For patients 18 years and older, -19.2% placebo-adjusted difference in BMI reduction (n=49), and primary endpoint of mean BMI reduction of -16.8% from baseline for all patients on setmelanotide therapy (n=33) compared with +2.4% BMI change for patients on placebo (n=16) at 52 weeks (p<0.0001) |
| - | For patients younger than 18 years, -20.2% placebo-adjusted difference in BMI reduction (n=71), and primary endpoint of mean BMI reduction of -16.3% from baseline for all patients on setmelanotide therapy (n=48) compared with +3.9% BMI change for patients on placebo (n=23) at 52 weeks (p<0.0001). |
• | 80% of patients on setmelanotide achieved BMI reduction of 5% or greater at 52 weeks |
| - | 63% of patients on setmelanotide achieved BMI reduction of 10% or greater at 52 weeks; |
| - | 51% of patients on setmelanotide achieved BMI reduction of 15% or greater reduction at 52 weeks; and |
| - | 43% of patients on setmelanotide achieved BMI reduction of 20% or greater at 52 weeks. |
The double-blinded, 52-week trial primary analysis cohort consisted of 120 patients, randomized 2:1. In addition to the primary endpoint and other data points above, clinically meaningful improvements were observed across key secondary endpoints at week 52, including:
•83% percent of patients on setmelanotide therapy achieved 5% or greater reduction in BMI (n=33 patients 18 or older) or BMI Z score reduction of 0.2 or greater points (n=48 patients younger than 18); and
•-1.4 placebo-adjusted mean change in weekly average of the daily maximal hunger score for patients 12 years old or older (n=81) (p=0.003).
No new safety signals with setmelanotide were observed, in line with setmelanotide’s well-established and well-understood safety profile. Consistent with prior clinical experience, setmelanotide was generally well tolerated in the TRANSCEND study. The most common treatment-emergent adverse events (affecting >20% of patients treated with setmelanotide) were nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation and headache. Only one drug-related serious adverse event was reported, and no serious adverse events leading to study discontinuation were reported. The breakdown of the reported adverse events is as below:
Parameter | Setmelanotide | Placebo | Overall |
At Least 1 AE | 81 (100.0) | 35 (89.7) | 116 (96.7) |
At Least 1 Drug-Related AE | 71 (87.7) | 26 (66.7) | 97 (80.8) |
At Least 1 Serious AE | 23 (28.4) | 3 (7.7) | 26 (21.7) |
At Least 1 Drug-Related Serious AE | 1 (1.2) | 0 | 1 (0.8) |
At Least 1 AE Which Resulted in Death | 1 (1.2) | 0 | 1 (0.8) |
At Least 1 AE Leading to Study Drug Withdrawal | 6 (7.4) | 5 (12.8) | 11 (9.2) |
At Least 1 AE Leading to Study Discontinued | 4 (4.9) | 0 | 4 (3.3) |
Most Common (≥20% Overall) | Setmelanotide | Placebo | Overall |
Skin hyperpigmentation | 45 (55.6) | 3 (7.7) | 48 (40.0) |
Nausea | 41 (50.6) | 15 (38.5) | 56 (46.7) |
Headache | 32 (39.5) | 12 (30.8) | 44 (36.7) |
Vomiting | 32 (39.5) | 8 (20.5) | 40 (33.3) |
Diarrhea | 19 (23.5) | 8 (20.5) | 27 (22.5) |
Injection site reaction | 19 (23.5) | 9 (23.1) | 28 (23.3) |
Also on April 7, 2025, the Company announced that it expects existing cash and cash equivalents and short-term investments to be sufficient to fund planned operations into 2027.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following Exhibits 99.1 and 99.2 shall be deemed to be furnished and not filed.
Exhibit | ||
No. | Description | |
99.1 | ||
99.2 | ||
104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RHYTHM PHARMACEUTICALS, INC. | |
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Date: April 7, 2025 | By: | /s/ Hunter Smith |
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| Hunter Smith |
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| Chief Financial Officer |