Item 2.02. Results of Operations and Financial Condition.
On May 9, 2022, Praxis Precision Medicines, Inc. (the “Company”) announced its
financial results for the quarter ended March 31, 2022. A copy of the press
release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01. Regulation FD Disclosure.
On May 9, 2022, the Company updated its corporate presentation for use in
meetings with investors, analysts and others. The presentation is available in
the “Investors + Media” portion of the Company’s website at
investors.praxismedicines.com and a copy is furnished as Exhibit 99.2 to this
Current Report on Form 8-K.
As previously announced, the Company provided a corporate update on May 9, 2022.
As part of the corporate update, the Company presented topline data from Part B
of its Phase 2a clinical study of PRAX-944 for the treatment of essential tremor
(“ET”). The presentation regarding this data is available in the “Investors +
Media” portion of the Company’s website at investors.praxismedicines.com and a
copy is furnished as Exhibit 99.3 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K under Items 2.02 and 7.01,
including Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 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 (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 set forth by specific
reference in such filing.
Item 8.01. Other Events.
On May 9, 2022, the Company announced positive topline results from Part B of
its Phase 2a study evaluating the safety and efficacy of PRAX-944 for the
treatment of ET. In the study, treatment with PRAX-944 resulted in clinically
meaningful improvements in function, which were supported by improvements in
In the open-label period through Day 42, patients treated with PRAX-944
demonstrated mean improvement from baseline of 42% in the Modified Activities of
Daily Living (“ADL”) score (N=11, nominal p<0.05). Following randomization, the
difference between patients who remained on treatment (N=6) through Day 56 and
those randomized to placebo (N=5) was clinically and statistically significant.
The Modified ADL is a composite score based on Essential Tremor Rating
Assessment Scale (“TETRAS”) ADLs with the addition of spiral drawings and
handwriting from the TETRAS performance scale.
Part B of the Phase 2a study included both an open-label and randomized
withdrawal period. In the open-label period, participants were to be titrated up
to a maximum dose of 120 mg over 28 days prior to a stable period at the highest
dose reached from Day 29 to Day 42. Participants who remained in the study
through Day 42 were then randomized one-to-one to either active drug or placebo
from Day 43 to Day 56, with a subsequent safety follow-up visit at Day 70.
PRAX-944 was generally well tolerated in Part B of the Phase 2a study, with no
new safety findings. In the study, eight of eleven participants completed the
open-label period at the highest dose of 120 mg. Three evaluable participants
discontinued during the open-label period due to adverse events (“AE”),
including one participant who had a pre-existing medical condition that led to a
medical procedure unrelated to study drug. Treatment emergent adverse events
were all mild to moderate, with the exception of one severe AE of essential
tremor that occurred in a placebo arm patient following withdrawal of PRAX-944.
Following the topline results from this study, the Company intends to update the
primary endpoint for the Company’s Phase 2b Essential1 Study from safety to
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press Release, dated May 9, 2022 99.2 Praxis Precision Medicines, Inc. May 2022 Corporate Presentation 99.3 Praxis Precision Medicines, Inc. PRAX-944 Essential Tremor Phase 2a Topline Results Presentation, dated May 9, 2022 104 Cover Page Interactive Data File (embedded within the inline XBRL document)
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