LPCN 2101 / Lipocine - LARVOL DELTA

Clinical Pharmacokinetics (PK) and Tolerability of a Novel Oral GABAA Receptor Positive Allosteric Modulating (PAM) Candidate for Epilepsy (AES 2025) - "Effective oral delivery of LPCN 2101 was confirmed in human with acceptable tolerability at all tested doses. Through formulation design, the PK of this novel NAS following oral administration can be tailored to meet specific therapeutic needs, supporting both acute and chronic treatment options. Results support clinical efficacy studies for this unique GABAAR modulating oral ASM option with potential to address refractory epilepsy and comorbidities."

Clinical • PK/PD data • CNS Disorders • Depression • Epilepsy • Mood Disorders • Psychiatry

Oral Toxicokinetics of a Bioidentical GABAA Receptor Modulating Neuroactive Steroid (NAS) Anti-seizure Medication (ASM) Candidate for Women with Epilepsy (WWE) (AES 2025) - "There is an unmet need for an oral ASM that is safe for women of childbearing age, including during pregnancy and postpartum periods.Oral formulations comprising a bioidentical NAS metabolite of progesterone, eltanolone, referred to as LPCN 2101, is a positive allosteric modulator (PAM) of GABAAR being developed to treat seizure disorders. Oral enablement of LPCN 2101, a unique bioidentical NAS with good tolerability, supports clinical testing of LPCN 2101 as a potential oral therapy option for seizure disorders. Noting observed lower NAS concentrations during the third trimester of pregnancy were associated with increased seizure burden, oral LPCN 2101 may be particularly relevant for women with epilepsy of childbearing age as an ASM with favorable benefit to risk profile."

Clinical • CNS Disorders • Epilepsy • Ophthalmology

New GABA-Targeting Therapies for the Treatment of Seizures and Epilepsy: II. Treatments in Clinical Development. (PubMed, CNS Drugs) - "The first group consists of positive allosteric modulators of GABA receptors and includes Staccato alprazolam (an already marketed benzodiazepine being repurposed in epilepsy as a potential rescue inhalation treatment for prolonged and repetitive seizures), the α2/3/5 subtype-selective agents darigabat and ENX-101, and the orally active neurosteroids ETX155 and LPCN 2101...These include bumetanide, a diuretic agent that has undergone clinical trials in phenobarbital-resistant neonatal seizures and for which the rationale for further development in this indication is under debate, and ivermectin, an antiparasitic drug currently investigated in a randomised double-blind trial in focal epilepsy. The last group comprises a series of highly innovative therapies, namely GABAergic interneurons (NRTX-001) delivered via stereotactic cerebral implantation as a treatment for mesial temporal lobe epilepsy, an antisense oligonucleotide (STK-001) aimed at upregulating NaV1.1 currents..."

Journal • Review • CNS Disorders • Epilepsy • Gene Therapies

LIPOCINE INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "We are currently evaluating an additional NAS candidate, LPCN 2101, for women with epilepsy ('WWE'). We have completed a pre-clinical study for LPCN 2101 which demonstrated promising PK results, safety and tolerability. In July 2022 our IND was accepted by the FDA for LPCN 2101 for adults with epilepsy and we plan to initiate a Phase 2 IND opening proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101 in 2023 subject to the availability of additional resources."

New P2 trial • CNS Disorders • Epilepsy

FDA Clears LPCN 2101 IND for Adult Epilepsy Treatment (PRNewswire) - "Lipocine Inc...announced today that the U.S. Food and Drug Administration ('FDA') has accepted the company's Investigational New Drug Application ('IND') for its neuroactive steroid ('NAS') candidate, LPCN 2101, as a potential treatment for adults with epilepsy. Lipocine plans to initiate a Phase 2 photosensitive epilepsy ('PSE') study to evaluate the safety, tolerability, and efficacy of oral LPCN 2101."

IND • CNS Disorders • Epilepsy

"$LPCN FDA Clears LPCN 2101 IND for Adult Epilepsy Treatment https://t.co/pJTrC2GGaE" (@stock_titan)

CNS Disorders • Epilepsy

LIPOCINE ANNOUNCES PRESENTATION AT 2022 EPILEPSY FOUNDATION PIPELINE CONFERENCE (PRNewswire) - "Lipocine Inc...presented 'LPCN 2101: An Endogenous Neuroactive Steroid for Epilepsy' today at the 2022 Epilepsy Foundation Pipeline Conference. The conference is held every two years to bring together decision-makers in the field of epilepsy treatment, therapeutic innovation and development, showcasing the latest developments in the epilepsy pipeline....Pending U.S. FDA clearance of its IND, Lipocine plans to conduct a proof-of-concept study in the second half of 2022."

Clinical • New trial • CNS Disorders • Epilepsy