Lateral-Pharma-Red

To Investigate the Efficacy of Oral LAT8881

For the Treatment of Neuropathic Pain

Clinical Trial LAT-NP-001 Now Underway
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To Investigate the Efficacy of Oral LAT8881

Clinical Trial LAT-MIG-001 Now Underway

For the Treatment of Migraine

Lateral Pharma Pty Ltd Is a privately-owned biotechnology company that has 2 phase IIa clinical trials underway

L

ateral Pharma commenced operations in May 2015 to repurpose LAT8881, a Phase 2 orally-available compound with extensive toxicology and human safety data, into new high potential indications.

LAT8881 is a 16 amino acid peptide modelled on the C-terminus segment of human growth hormone (hGH).

In non-human testing and human clinical trials with 750 patients dosed to date LAT8881 has been shown to have an excellent preclinical and clinical safety profile, with none of the side effects associated with hGH, such as raised IGF-1 levels or insulin resistance, and has no involvement with the growth hormone receptor.

LAT8881 was originally developed for obesity, based on extensive animal model data in mice, rats and pigs. Lateral Pharma has focused on repurposing LAT8881 for treatments of neuropathic pain, osteoarthritis and other chronic painful diseases. Results to date demonstrate:

  • LAT8881 has an established excellent safety profile in animals and humans, with no adverse CNS or other side effects commonly seen with established pain drugs
  • LAT8881 has a novel mechanism of action distinct from other pain drugs
  • LAT8881 has oral efficacy in several animal models of neuropathic and osteoarthiritis pain comparable to existing approved drugs
  • LAT8881 is active following local and systemic injection and oral delivery
  • Multiple back-up and follow on compounds have been identified with a similar Mode of Action

A  Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain commenced in March 2019. A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine commenced in October 2019.

Current Clinical Trials

Phase IIa – Neuropathic Pain

LAT-NP-001  a Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain is currently underway, using twice daily delivery of 30mg of LAT8881 by capsule for the treatment of the painful symptoms of post herpetic neuralgia and diabetic neuropathy. Lateral Pharma is looking for efficacy at least comparable to Lyrica and clinical safety comparable to prior clinical studies with LAT8881.

LAT-NP-001 started in March 2019 at four Australian sites: Melbourne, Western Sydney, Central Coast and Brisbane. Two UK sites commenced in October, Bristol and Glasgow.

The clinical trial protocol for this study was developed by Lateral’s in-house team, with input from the clinical advisory board and experienced clinicians including Prof Paul Rolan, Prof Ralf Baron, Prof Tony Pickering and Prof Andy Rice.

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Phase IIa – Migraine

LAT-MIG-001 a Phase lla Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine is currently underway, using two 30mg capsules of LAT8881 with the onset of migraine.

LAT-MIG-001 started in October 2019 at three Australian sites: Melbourne, Western Sydney and NSW Central Coast.

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Safety

The safety and toxicity of LAT8881 has been evaluated using conventional acute and chronic repeat-dose studies in animals. Toxicology data from rodents and primates indicated no significant safety signals attributable to LAT8881 up to doses of 100mg/kg/day for 6 months following oral delivery in rats and 50mg/kg/day for 9 months in cynomolgous monkeys.

In the six (6) human clinical trials involving 925 patients conducted at Medeval, Manchester, UK and seventeen (17) major Australian hospitals and medical centres between 2001 and 2007 with 694 patients dosed with LAT8881 it has been shown that LAT8881 is safe and well tolerated in humans.

This safety and tolerability record of LAT8881 was further validated in July 2014 by the receipt of a self-affirmed GRAS (Generally Recognized as Safe) status recognition to enter the U.S. market as a food additive. The peptide had received in June 2012, GRAS status in the USA conditional on the publication of safety related data in peer-reviewed scientific journals. Two such scientific papers detailing these safety aspects are available for downloading here.

GRAS status allows LAT8881 to be sold as a component in conventional and functional foods, drinks and dietary supplements in the USA at the daily level of up to 1 mg per person.

Potential Utility of LAT8881

Neuropathic Pain

Chronic neuropathic pain remains a clinical area with high unmet need due to several factors. Including a relative lack of investment in new pain drugs by biotech and pharma; Clinical failures/delays due to safety issues in humans (anti-NGF) or failure to demonstrate efficacy in trials with the overall lower success rate for pain drugs transitioning from Phase 1 to Approval of 2% compared to average for all drugs of 9.6%; and  the highly publicized safety and misuse concerns with opioids and more recently with gabapentinoids…

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Osteoathritis

Osteoarthritis (“OA”)is the most common joint disease with 12.1% of US adults showing symptoms in the knee and obesity being associated with a 3.5 fold prevalence of OA in US adults between 60-64 years of age. (Medtrack database). The majority of treatments only address the pain associated with OA. Across the seven major markets of the U.S, France, Germany, Italy, Spain, the U.K and Japan the osteoarthritis market was worth $3.25B in 2014 and expected to grow at a Compound Annual Growth Rate of 17.8%  to reach $10.49B by 2024 (GlobalData, 2016)…

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The Team Behind LAT8881

Peter Francis
Chairman/Director
David Kenley
CEO
Dr. Gavin Shepherd
Director
Barry Pang
Director
Colin Hannah
Director
David Williamson
CFO
Dr. Nicky Wallis
Clinical Project Manager & VP Operations
John Pang
Operations and Projects Manager

Contact

  

Lateral Pharma Pty Ltd 

ABN 40 605 241 665

14/114 William Street

Melbourne VIC 3000

Australia

E: info@lateral-pharma.com

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