Item 7.01. Regulation FD Disclosure.
On
The information in this Item 7.01, including Exhibit 99.1 attached hereto, 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, 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, except as expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On
Preliminary results reported today include data as of
The initial pharmacokinetic (PK) analysis of FT-7051 documented rapid absorption, which produced maximum blood concentrations within two hours. The 150 mg dose achieved drug concentrations that approached the predicted efficacious dose based on modeling with preclinical results. Skin biopsies of the men participating in the study demonstrated a reduction in H3K27AC, a marker of activity in the CBP/p300 pathway, the target of FT-7051.
The majority of the treatment-emergent adverse events (TEAEs) were mild or moderate, at Grade 2 or lower, with no events leading to treatment discontinuation. One patient experienced Grade 3 hyperglycemia, which was medically managed. Following a dose reduction, this patient remained on treatment and experienced an ongoing PSA decline of greater than 50% at 12 weeks and greater than 80% at 16 weeks. Based upon these safety results, dose escalation is ongoing. The trial is continuing according to its adaptive design to further understand the safety and tolerability of FT-7051, gather data on clinical response including PSA and radiographic tumor response, as well as the assessment of secondary endpoints of clinical response.
The disclosure under this Item 8.01 contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, express or implied statements regarding the
Company's beliefs and expectations regarding: initial results to date for the
FT-7051 open label Phase 1 clinical trial; the therapeutic potential, clinical
benefits and anticipated safety related to FT-7051; whether initial results from
the Company's clinical trials are predictive of final trial results or future
clinical studies; the Company's ability to enroll patients in a timely manner
and retain such patients throughout the course of the study; and the Company's
planned presentation of data at the 2021
Any forward-looking statements under this Item 8.01 are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained under this Item 8.01, including, without limitation, those risks and uncertainties related the Company's ability to execute on its strategy; the therapeutic potential and safety of FT-7051; the timing and completion of the Phase 1 study of FT-7051 (the Courage Study) and final audit and quality controlled verification of initial data and related analyses; positive results from initial data analyses may not be
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predictive of final results; risks related to patient enrollment and retention
in the Company's clinical trials; risks related to the Company's planned
regulatory submissions and developments; and other risks identified in the
Company's filings with the
Item 9.01. Exhibits (d) Exhibits 99.1 Press release issued byForma Therapeutics Holdings, Inc. onOctober 7, 2021 , furnished herewith. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 3
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