| Item 7.01 | Regulation FD Disclosure. |
On January 21, 2025, Disc Medicine, Inc. (the “Company”) issued a press release outlining positive feedback from the Company’s Type C meeting with the U.S. Food & Drug Administration (the “FDA”) to discuss the APOLLO post-marketing confirmatory trial for bitopertin in erythropoietic protoporphyria (“EPP”) and X-linked protoporphyria (“XLP”). A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is intended to be 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 liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the material attached hereto as Exhibit 99.1.
On January 21, 2025, the Company announced positive feedback from its Type C meeting with the FDA to discuss the APOLLO post-marketing confirmatory trial for bitopertin in EPP and XLP. The meeting resulted in alignment on the design of the APOLLO post-marketing confirmatory trial. Key features include:
| | • | | Co-primary endpoints of average monthly total time in sunlight without pain between 10:00 and 18:00 during the last month of the 6-month treatment period and percent change from baseline in whole blood metal-free protoporphyrin IX (“PPIX”) after 6 months of treatment; |
| | • | | Other measures of efficacy such as occurrence of phototoxic reactions, cumulative total pain-free time in sunlight, patient global impression of change (“PGIC”) and time to prodome; |
| | • | | Selection of 60 mg dose of bitopertin and 6-month treatment duration; |
| | • | | Inclusion of patients aged 12+ with EPP, including XLP; and |
| | • | | Double-blind, placebo-controlled study with ~150 patients randomized 1:1. |
The Company plans to initiate the APOLLO trial by mid-2025 and will include sites in the United States, Canada, Europe and Australia. The Company anticipates submitting a New Drug Application (“NDA”) for bitopertin in EPP and XLP in the second half of 2025 under the Accelerated Approval Program. Based on the anticipated timing of the NDA submission, the Company expects enrollment for the APOLLO trial to be well underway by the Prescription Drug User Fee Act date for accelerated approval, if granted.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s expectations with respect to its potential APOLLO confirmatory clinical study of bitopertin in EPP and XLP patients, including the proposed study design, the anticipated timeline, and the results thereof; and the possible regulatory path forward for bitopertin in EPP, including whether the FDA will determine that the accelerated approval pathway continues to be appropriate, the treatment of the APOLLO clinical study as a post-marketing confirmatory trial and the timeline for a potential NDA submission and accelerated approval, if granted, and whether the NDA submission will meet the standards of accelerated approval. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of the Company’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
