Lipocine shifts focus to CNS; Drug approval triggers capital infusion at Fennec
Lipocine, after a yearslong quest to snag FDA approval for its oral testosterone drug, has decided to shift focus to central nervous system disorders.
The Salt Lake City biotech offered up the new vision Monday morning in what CEO Mahesh Patel says will allow the company to “manage our resources efficiently.”
Lipocine will continue focusing on oral drugs, this time with endogenous neuroactive steroids (NAS) that it hopes can treat various CNS conditions. This comes half a year after its oral testosterone replacement therapy for hypogonadism was approved, following multiple FDA snags, and is being marketed by license-holder and commercialization partner Antares Pharma. Lipocine still seeks an ex-US commercialization leader.
On the list of potential disorders that Lipocine can address, based on studies showing NAS’ ability to impact the CNS, are depression, movement disorders, epilepsy, anxiety and neurodegenerative diseases. First up are postpartum depression and women with epilepsy, Lipocine said. The company expects to have results for a pharmacokinetic bridge study of the PPD asset in the first quarter of next year.
The company will finish up its Phase II study of LPCN1148 in liver cirrhosis. Lipocine will look for partners for that asset, as well as LPCN1144 for non-cirrhotic NASH, LPCN1107 for prevention of pre-term birth and LPCN1111 for TRT. — Kyle LaHucik
Third time’s the charm for Fennec, and money flows in
As part of its agreement last month, Fennec now has $20 million to tap into as it bankrolls the launch of its new drug.
Days ago, the FDA approved Fennec’s drug for lowering the risk of hearing loss in pediatric cancer patients who are on chemotherapy. That triggered the closing of $20 million of senior secured promissory notes from Petrichor Healthcare Capital Management. The investor offered up $5 million last month at the time of the agreement.
Another $20 million is available prior to the end of 2023. The company’s shares $FENC were down more than 6.5% after the opening bell on Monday.
The Pedmark approval came after two previous failed attempts for Fennec. — Kyle LaHucik
Anebulo unveils interim data on its marijuana overdose treatment
In the first two cohorts out of at least six for Part B of its Phase II clinical trial, Anebulo Pharmaceuticals said its drug for marijuana overdose had an effect.
Two cohorts were challenged with 21 mg of THC and then were given either 30 mg or 10 mg of ANEB-001 — a cannabinoid receptor antagonist — or placebo. The participants who got placebo felt high, had increased body sway, and decreased alertness. But those who got Anebulo’s drug had significant reductions in all three of those symptoms.
Anebulo noted the effect of its drug was similar to what it had seen in Part A, which had challenged participants with half the amount of THC and treated them with 50 or 100 mg of ANEB-001.
The Austin, TX-based biotech will continue testing its drug for acute cannabinoid intoxication, or ACI for short, in additional cohorts of up to 15 participants. The trial is being run in the Netherlands.
In a statement, Anebulo CEO Simon Allen said:
We are currently exploring the effects of delayed dosing to better understand real-world conditions. In this circumstance, we challenge subjects with THC one hour before administering ANEB-001. With no FDA approved therapeutic, ACI often requires lengthy emergency department stays with expensive follow-on interventions for neuropsychiatric complications such as anxiety and acute psychosis. We believe ANEB-001 will play a critical role in reducing the burden of ACI for the patient and the healthcare system.
— Lei Lei Wu