Sydney, Australia – 14 October 2024 – LTR Pharma Limited (ASX: LTP) (“LTR Pharma” or “the Company”) is pleased to announce the successful completion of the pivotal clinical study for SPONTAN®, the Company’s novel intranasal formulation of vardenafil for the treatment of erectile dysfunction (ED). The study’s pharmacokinetic and safety data demonstrate SPONTAN’s rapid onset of action and enhanced bioavailability compared to traditional oral ED medications, positioning it as a potential market disruptor in the global ED market.
Key Highlights:
-
470% Faster Absorption: SPONTAN® achieved a time to maximum plasma concentration (Tmax) of just 12 minutes, compared to 56 minutes for oral vardenafil tablets, representing a 470% faster absorption rate.
-
Comparable Bioavailability: Despite using half the dose, SPONTAN displayed 111.8% dose-normalised bioavailability relative to the oral tablet, indicating clinically relevant comparable efficacy.
-
Higher Peak Concentration: SPONTAN delivered a 155.6% higher peak concentration (Cmax) than the oral tablet, enhancing its potential effectiveness.
-
Favourable Safety Profile: SPONTAN was well-tolerated, with no serious adverse events reported. All treatment-emergent adverse events (TEAEs) were mild to moderate and transient, consistent with the known safety profile of vardenafil.
Comments from the Chief Medical Officer:
Professor Geoffrey Strange, Chief Medical Officer of LTR Pharma, commented:
“These results are highly encouraging from a clinical perspective. The rapid onset of action and pharmacokinetic profile of SPONTAN® have the potential to address significant unmet needs in erectile dysfunction treatment. The speed of absorption, coupled with the excellent bioavailability and safety profile, offers patients a more spontaneous and convenient therapeutic option.”
The study, which involved 18 healthy adult males, used a cross-over design to compare SPONTAN Nasal Spray (5 mg vardenafil) with an oral tablet (10 mg vardenafil). Blood samples were taken at multiple intervals over 24 hours, confirming the significantly faster onset and comparable bioavailability of SPONTAN despite its lower dose.
Regulatory Pathway and Commercialisation:
The positive results from this pivotal study strengthen LTR Pharma's position in ongoing global partnering and licensing discussions. Additionally, the data will support the Company’s engagement with key regulatory bodies, including the US Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA).
Comments from the Chairman:
Lee Rodne, Chairman of LTR Pharma, added:
“These study results mark a significant milestone for LTR Pharma. SPONTAN’s pharmacokinetic profile and rapid onset of action demonstrate its potential to disrupt the global ED market. We are now well-positioned to accelerate our commercialisation strategy, including advancing regulatory discussions and exploring strategic partnerships. This success reinforces our commitment to delivering innovative solutions that can significantly improve patients' lives while creating value for our shareholders.”
Watch how SPONTAN® | Novel Intranasal Technology works here
Learn more: ltrpharma.com
About us:
LTR Pharma is focused on improving men’s health, both physically and mentally, through the commercialisation of an innovative nasal spray treatment for Erectile Dysfunction. LTR Pharma’s lead product, SPONTAN®, is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. SPONTAN works within 10 minutes or less, empowering users with greater control over the timing, spontaneity, and enjoyment of sexual experiences.
Contact details:
For further information, please contact:
Jane Morgan
Investor and Media Relations
Email: [email protected]