APLT Reports Positive Phase 3 Trial Results from Interim Analysis of Govorestat

February 15, 2024

DENVER, Colo., Feb 15, 2024 (247marketnews.com) – Applied Therapeutics, Inc. (NASDAQ:APLT) reported, this morning, achieving primary endpoints and several key secondary endpoints in its interim 12-month results from the ongoing Phase 3 INSPIRE trial, adouble-blind placebo-controlled registrational study evaluating the effect of once-daily (QD) oral govorestat (AT-007) in 56 patients aged 16-55 with SORD Deficiency in the US and Europe.

“Our commitment to bringing first of their kind therapies to rare disease indications with no existing treatment options is at the core of our work,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “We are excited by the prospect of providing patients with SORD Deficiency with a treatment option that has the potential to slow disease progression and the consistent benefit demonstrated by govorestat.”

“We are thrilled by the results of this 12-month interim analysis, which demonstrate govorestat’s effectiveness in reducing sorbitol levels and improving key functional measures and patient reported outcomes in SORD Deficiency, including lower limb function, upper limb function, fatigue and pain,” said Riccardo Perfetti, MD, PhD, Chief Medical Officer of Applied Therapeutics. “We look forward to meeting with regulatory agencies regarding a path to potential approval based on this data, and endeavor to bring this important treatment to patients as quickly as possible.”

APLT is trading at $3.12, up $0.44 (+16.41%), on 1.2M premarket shares.

Its 52-week range is $0.7571 to $4.42. Today’s premarket high is $3.62 and its next key inflection point is $3.22.

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Cautionary Statement Regarding Forward Looking Information
Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

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