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LTR Pharma Begins Phase II Dosing for Intranasal Erectile Dysfunction Spray SPONTAN

Story Highlights
  • LTR Pharma has dosed first patients in its Phase II study of SPONTAN, its rapid-acting intranasal erectile dysfunction spray.
  • The Phase II pharmacokinetic data, including in older men, is expected to support FDA submission and strengthen LTR Pharma’s US strategy.
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LTR Pharma Begins Phase II Dosing for Intranasal Erectile Dysfunction Spray SPONTAN

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LTR Pharma Limited ( (AU:LTP) ) just unveiled an announcement.

LTR Pharma has begun dosing the first patients in its Phase II pharmacokinetic clinical study of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, marking a key transition from recruitment to active data generation. The study will evaluate single- and multiple-dose pharmacokinetics in about 27 healthy male participants across three cohorts, with roughly half aged 65 or older in line with FDA geriatric-use guidance, and the resulting data is expected to support a future US regulatory submission and inform prescribing information for older patients, representing an important milestone in LTR Pharma’s commercial and regulatory strategy for SPONTAN in the US market.

More about LTR Pharma Limited

LTR Pharma Limited is a commercial-stage pharmaceutical company focused on innovative therapies for significant unmet medical needs via a proprietary intranasal drug-delivery platform. The company has commercialised rapid-acting intranasal treatments for erectile dysfunction in Australia, led by its SPONTAN and ROXUS sprays, and is advancing regulatory pathways in the US and other key markets. It is also developing OROFLOW, an intranasal therapy for oesophageal motility disorders, and is using strategic partnerships to expand its pipeline and international footprint.

Average Trading Volume: 327,333

Technical Sentiment Signal: Buy

Current Market Cap: A$102.6M

For an in-depth examination of LTP stock, go to TipRanks’ Overview page.

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