Lipocine has announced plans to commence Phase II clinical trial of its neuroactive steroid (NAS) candidate, LPCN 2101, to potentially treat adults with epilepsy.

The plans come after the US Food and Drug Administration (FDA) granted clearance for the company’s Investigational New Drug Application (IND) for LPCN 2101.

An oral endogenous NAS, LPCN 2101 is a positive allosteric modulator (PAM) of GABAA receptor. 

It is claimed to have potential treatment effects on neurological and mood disorders. 

Lipocine intends to commence the Phase II photosensitive epilepsy (PSE) trial in the second half of this year.

The trial will evaluate the safety, tolerability, and efficacy of oral LPCN 2101 in subjects with an EEG-measurable photoparoxysmal response (PPR) induced by light stimulation. 

A decline in photosensitivity will be analysed following a single dose of a potential anti-seizure medication (ASM).

The company noted that positive data from the PSE model is established to be a reliable marker of antiseizure efficacy for various approved ASMs.

In the preclinical studies of LPCN 2101, no concerning safety and tolerability signals were reported with the therapy showing a favourable pharmacokinetic profile.   

Lipocine chairman, president and CEO Dr Mahesh Patel said: “We are excited to advance further testing of LPCN 2101. 

“We believe it has the potential to address the unmet medical needs in epilepsy management as well as mood disorders comorbidities, particularly in women of childbearing age.”

The company uses its commercially validated technology for the development of new products for treating metabolic and central nervous system ailments with high unmet medical needs. 

Apart from LPCN 2101, the clinical development pipeline of Lipocine comprises LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and LPCN 1154.