Rapport Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure
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Item 7.01 Regulation FD Disclosure.
On January 9, 2025, Rapport Therapeutics, Inc. (the “Company”) announced new data from its positron emission tomography (“PET”) trial and second multiple ascending dose (“MAD-2”) trial for RAP-219. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included under Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, 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 liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On January 9, 2025, the Company announced the following results from its recent PET and MAD-2 trials for RAP-219, based on preliminary analysis of the data:
The PET trial (RAP-219-103) was an open label trial in healthy volunteers designed to confirm neuroanatomical expression of TARPg8 and establish the relationship between pharmacokinetics (“PK”) and brain target receptor occupancy (“RO”) with RAP-219. The trial included three cohorts: Cohort 1 was given the same dosing regimen currently being used in the Phase 2a trial in focal epilepsy (0.75 mg daily for 5 days, followed by 1.25 mg daily for 9 days), and lower doses were used in the other two cohorts to better characterize the plasma concentration versus RO relationship. Cohort 2 was given 0.25 mg daily for 14 days and Cohort 3 was given 0.25 mg daily for 7 days, followed by 0.5 mg daily for 7 days.
PET trial results are summarized below:
| • | The PET data demonstrated that Cohort 1 (the dosing regimen utilized in the ongoing Phase 2a trial in focal epilepsy) exceeded the target RO range associated with maximal efficacy in prior preclinical models (50%-70%) within five days of dosing, while maintaining a differentiated tolerability profile generally consistent with prior Phase 1 trial findings. |
| • | The trial confirmed that the expression of TARPg8-containing AMPA receptors is enriched in the hippocampus and cerebral cortex and is minimal in the cerebellum and brain stem. |
| • | Collectively, data from the PET and MAD-2 trials demonstrated that plasma concentrations and associated target RO could be achieved within 5 days. |
The MAD-2 (RAP-219-104) trial was a double-blind, placebo-controlled trial in healthy volunteers and was the second MAD trial of RAP-219. The trial was designed to further evaluate safety and tolerability with continued dose escalation, as well as to shorten time to reach predicted therapeutic levels of RAP-219. The trial included three cohorts: Cohort 1 (0.75 mg for 3 days, 1.25 mg for 3 days, 1.75 mg for 2 days), Cohort 2 (0.75 mg for 2 days, 1.25 mg for 2 days, 1.75 mg for 4 days), and Cohort 3 (0.5 mg for 2 days, 1 mg for 2 days, 1.75 mg for 24 days).
MAD-2 trial results are summarized below:
| • | RAP-219 was generally well tolerated. All treatment emergent adverse events were Grade 1 or 2 and generally consistent with tolerability observed in prior Phase 1 trials. |
| • | Unlike with many anti-seizure medications, no sedation or motoric impairments were observed with RAP-219, consistent with target biology and preclinical observations. |
| • | Target exposures and RO were achieved within 5 days of dosing across various dosing regimens. |
Clinical conduct of the PET and MAD-2 trials is complete, and the clinical study reports for both are in progress.
On January 9, 2025, the Company also announced that Bradley Galer, M.D., has stepped down as its Chief Medical Officer, and a search for his successor is underway.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press Release issued by Rapport Therapeutics, Inc. on January 9, 2025, furnished herewith. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
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.
| Rapport Therapeutics, Inc. | ||||||
| Date: January 10, 2025 | By: | /s/ Troy Ignelzi | ||||
| Troy Ignelzi Chief Financial Officer | ||||||