Press Release

Innovative design of ongoing Phase 3 clinical program expected to set precedent for future clinical trials in essential tremor

BOSTON, April 12, 2024 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that it will deliver presentations of two abstracts showcasing progress of its clinical program evaluating ulixacaltamide for adults with essential tremor (ET) at the American Academy of Neurology (AAN) 2024 Annual Meeting taking place in Denver, Colorado, April 13 – 18, 2024.

“With Essential3, we’ve developed a decentralized trial program unlike any other in ET, and among the first in the industry,” said Marcio Souza, president and chief executive officer of Praxis. “The experiences of patients with ET are often overlooked so we designed a trial that removes typical obstacles to participation and concentrates on endpoints that truly matter. In our earlier Phase 2 Essential1 study, we observed that patients who were already on propranolol experienced additional benefits when adding ulixacaltamide. Our findings and learnings to date highlight the promise of ulixacaltamide for those living with ET.”

Praxis at AAN 2024 | Colorado Convention Center

Connect with members of our team at booth #1834 or head to one of our presentations listed below where we will share updates on our journey to develop a new ET therapy.

P3003: An Innovative Multi-Study Phase 3 Program to Evaluate the Efficacy and Safety of Ulixacaltamide: The Future of Clinical Trial Design in Essential Tremor

A poster presentation showcasing Praxis’ novel registrational study design

• Sunday, April 14 | 5:30 – 6:30 PM MST | Exhibit Hall B-E
  

Emerging Neurologic Care Industry Presentation: Essential3: An Innovative, Decentralized Phase 3 Essential Tremor Program

An industry platform presentation highlighting updates on Praxis’ Phase 3 registrational program

• Tuesday, April 16 | 1:00 – 1:20 PM MST | Exhibit Hall B-E
  

S30.010: Assessing Clinically Meaningful Improvement Associated with Ulixacaltamide Treatment in Adults with Essential Tremor on Concomitant Propranolol: Findings from Essential1

An oral presentation demonstrating potential benefit of ulixacaltamide over propranolol

• Wednesday, April 17 | 2:48 – 3:00 PM MST | Four Seasons 4
  

Selected materials will be made available on the Resources page of Praxis’ website following presentation at AAN 2024: https://praxismedicines.com/resources/.

About Ulixacaltamide
Ulixacaltamide is a differentiated and highly selective small molecule inhibitor of T-type calcium channels designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity. Ulixacaltamide, the most advanced program within Praxis’ Cerebrum™ small molecule platform, is currently in development for the treatment of essential tremor. www.praxisessentialtremor.com.

About Praxis 
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on Facebook, LinkedIn and Twitter/X. 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Praxis’ future expectations, plans and prospects, including, without limitation, statements regarding the development of Praxis’ product candidates and the potential therapeutic effects of Praxis’ product candidates, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2023 and other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Investor Contact: Praxis Precision Medicines investors@praxismedicines.com 857-702-9452 Media Contact Ché Knight LifeSci Communications cknight@lifescicomms.com 713-582-0681