LAT8881

Human Clinical Trials

Lateral-Pharma

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

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.

Phase IIa – Neuropathic Pain

A Phase IIa Proof of Concept study LAT-NP-001 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 Gabapentanoids 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 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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Past Clinical Trials

A Phase IIb study was conducted (capsule formulation) for 12 weeks (METAOD005). The patients were clinically obese males, and females of non-child bearing potential.

  • LAT8881 was well tolerated over the dose range; there were no changes of clinical significance in vital signs, safety laboratory tests or ECGs during the study.
  • This study demonstrated that daily oral administration of LAT8881 was safe and well tolerated.

The OPTIONS Study was a Phase IIb, randomised, double-blind, placebo-controlled, multicentre, parallel-group study to assess the efficacy, safety, and tolerability of 24 weeks of treatment with different doses of LAT8881 tablets for weight loss in obese adults (METAOD006). A total of 413 subjects contributed to the primary analysis.

The results of the OPTIONS study did not meet its primary clinical endpoint and the project was terminated by Metabolic in February 2007.

At the end of 2001 the first Phase IIa study was completed (METAOD002). This was a double-blind placebo-controlled 4 ´ 4 Latin Square design study in which 24 healthy clinically obese males participated.

  • LAT8881 was well tolerated over the dose range: there were no study drug-related withdrawals, serious AEs, clinically significant AEs, or changes of clinical significance in vital signs, safety laboratory tests, or ECGs during the study.
  • No significant changes in glucose or insulin-like growth factor 1 (IGF-1) levels were observed following LAT8881 treatment compared with placebo.

A second double-blind placebo-controlled 4 x 4 Latin Square design Phase IIa study was conducted using single oral doses to evaluate safety, tolerability and pharmacodynamic endpoints in healthy, clinically obese males (METAOD003).

  • LAT8881 was well tolerated over the oral dose range: there were no study drug-related withdrawals or serious AEs, clinically significant AEs, or changes of clinical significance in vital signs, safety laboratory tests or ECGs during the study.
  • No significant differences in IGF-1 values were evident for any of the doses compared to placebo.

A third Phase IIa study was conducted to assess the safety of multiple daily oral dosing of LAT8881(METAOD004).

  • LAT8881 was well tolerated over the oral dose range: there were no study drug-related withdrawals or serious AEs, clinically significant AEs, or changes of clinical significance in vital signs, safety laboratory tests or ECGs during the study.

A Phase I study was conducted in 2001 (METAOD001). LAT8881 was administered intravenously to 14 healthy male volunteers.

  • LAT8881 was well tolerated over the dose range.
  • There were no clinically significant adverse events (AEs); or significant abnormalities in vital signs, safety laboratory tests or electrocardiograms (ECGs) during the study.