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Lipocine Inc (LPCN)

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Last Post: 3/3/2021 7:22:21 PM - Followers: 56 - Board type: Free - Posts Today: 0

 

 

 

                                                                                                                 675 Arapeen Drive
                                                                                                                 Suite 202
                                                                                                                 Salt Lake City, Utah 84108

                                                                                                                 Our telephone number is (801) 994-7383

Lipocine became a public company through a reverse merger in July 2013. Immediately after the reverse merger the Company raised $38 million in a private placement to institutional investors at $6.00 per share.
 

Pipeline

 

Proprietary Solubilization Technology

ENTAILS REPOSITIONING OF ESTABLISHED DRUGS WITH SIGNIFICANTLY IMPROVED PATIENT COMPLIANCE.

 

Lipocine pipeline products are based on its proprietary solubilization technology for effective oral delivery of water insoluble drugs to improve patient compliance.

 
Pipeline chart



IMPROVED DRUG ABSORPTION | BETTER PATIENT COMPLIANCE

Improving Health

 

We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. We improve compliance, absorption, and more with our proprietary drug delivery technologies. 

 

Metabolic & Endocrine Solutions

LPCN 1144

 

Changing the Treatment of NASH

Finding A Solution to Fatty Liver Diseases

Targeted For Non-Alcoholic Steatohepatitis (NASH)

LPCN 1144, an oral prodrug of bioidentical testosterone, is being developed as a treatment for pre-cirrhotic non-alcoholic steatohepatitis ("NASH") and is currently being studied in a Phase 2 paired biopsy NASH confirmed clinical study. Liver imaging results from the Phase 2 clinical study are expected by the end of 2020 with biopsy results expected by the end of the second quarter of 2021.

 

TLANDO ™

 

ORAL PRODUCT CANDIDATE

TESTOSTERONE REPLACEMENT THERAPY

ADDRESS ISSUES OF OTHER TRT PRODUCTS ON THE MARKET

TLANDO is an oral testosterone replacement therapy product candidate containing Testosterone Undecanoate (TU) that is designed to help restore normal testosterone levels in males for conditions associated with a deficiency or absence of endogenous testosterone.

TLANDO is designed to overcome many of the issues related to TRT products on the U.S. market. TLANDO is being studied for both Primary and Secondary hypogonadism and is targeting the established chronic US TRT market.
                                                                                                   
                                                                                                 

TLANDO XR (LPCN 1111)

 

TLANDO XR

A Candidate For Oral TRT For Once Daily Dosing

                                                                                                         

Pioneering For Next Generation Oral TRT

TLANDO XR  is a next-generation, novel ester prodrug of testosterone which uses the patent protected Lip'ral technology to enhance solubility and improve systemic absorption. Lipocine completed a Phase 2b dose finding study in hypogonadal men in 2016. The primary objectives of the Phase 2b clinical study were to determine the starting Phase 3 dose of TLANDO XR along with the safety and tolerability of TLANDO XR and its metabolites following oral administration of single and multiple doses in hypogonadal men. The Phase 2b clinical trial was a randomized, open label, two-period, multi-dose PK study. Results suggested that the primary objectives were met, including identifying the dose expected to be tested in the planned Phase 3 study. Good dose-response relationship was observed over the tested dose range. Additionally, the target Phase 3 dose met primary and secondary end points. TLANDO XR was well tolerated with no drug-related severe or serious adverse events reported in the Phase 2b study.

                                                                                                                   

LPCN 1148

An Oral Prodrug of a Bioidentical Testosterone Being Developed for the Treatment of Cirrhosis


                                                                                                         

A Therapeutic Treatment For Cirrhosis Patients

Cirrhosis is an end-stage non-alcoholic fatty liver disease (NAFLD) for which there is no FDA approved drug treatment. During 2015, approximately 1.3M NASH patients had cirrhosis (fibrosis grade 4). NASH cirrhosis patients typically experience increased morbidity and symptoms of hypogonadism such as alteration of hair distribution, anemia, sexual dysfunction, testicular atrophy, muscle wasting, fatigue, osteoporosis, and gynecomastia.

Testosterone levels fall progressively with increased chronic liver disease severity. Low testosterone levels, reported in up to 90% of male cirrhotic patients, is known to increase adverse outcomes and is a predictor of mortality in these patients with increased risk of major infections, transplantation rates, increased risk of for hepatic decompensation, worsening of sarcopenia, and higher Child-Pugh score grade and MELD score. This could also include the severity of portal hypertension and ascites grade.

Our team is currently formulating plans to conduct a proof-of-concept study in male subjects with cirrhosis through consultations with the FDA and key opinion leaders to evaluate the therapeutic potential of LPCN 1148 for the treatment of cirrhosis.
 

LPCN 1107

Oral Product Candidate being Developed For The Prevention Of Recurrent Pre-Term Birth

 

Reducing
Pre-Term Births

LPCN 1107 is an oral product candidate of 17-alpha-hydroxyprogesterone caproate (HPC) under development for the indication of prevention of recurrent preterm birth. LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits.

LIP’RAL Technology

 

OPTIMIZING ABSORPTION FOR FASTER EFFECTS

Lip'ral is a patented technology based on lipidic compositions which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of the insoluble drug. Lip'ral presents insoluble drugs efficiently to the intestinal absorption site, thus bringing the absorption process under formulation control and making the product robust to physiological variables such as dilution, pH and food effects.

 
 
5005
 

Utilizes Bioacceptable Excipients

 

Conventional Manufacturing Processes - Easy To Scale-Up

 

Compositions Are Stable & Compatable for Encapsulation

 

Lip'ral enables development of superior oral products with:

 
 

Improved Solubilization & High Drug Loading Capacity

 

Improved Bioavailability

 

Faster & More Consistant Absorption

 

Reduced Sensitivity & Improved Patient Compliance

Treated Issues

 

Best-In-Class Health Solutions

Our revolutionary drug product candidates help combat the following conditions:

 
 
NAFLD/NASH/CIRRHOSIS
HYPOGONADISM
PRETERM BIRTH
 

Non-alcoholic fatty liver disease ("NAFLD") is a reversible condition wherein large vacuoles of triglyceride fat accumulate in liver cells via the process of steatosis.

NASH is a more advanced state of NAFLD and can progress to a cirrhotic liver and eventually hepatocellular carcinoma or liver cancer. Twenty to thirty percent of the U.S. population is estimated to suffer from NAFLD and fifteen to twenty percent of this group progress to NASH, which is a substantially large population that lacks effective therapy. NAFLD/NASH is becoming more common due to its strong correlation with obesity and metabolic syndrome, including components of metabolic syndrome such as diabetes, cardiovascular disease and high blood pressure. In men, especially with comorbidities associated with NAFLD/NASH, testosterone deficiency has been associated with an increased accumulation of visceral adipose tissue and insulin resistance, which factors contributing to NAFLD/NASH.

Preclinical and clinical studies in the literature have shown the prevalence of testosterone deficiency across the NAFLD/NASH histological spectrum wherein low testosterone was independently associated with NAFLD/NASH with an inverse relationship between testosterone and NAFLD/NASH.

Post hoc analyses of existing clinical trial in subjects with comorbidities typically associated with NASH indicate that oral testosterone therapy significantly and consistently reduces elevated levels of key serum biomarkers (liver function enzymes and serum triglyceride) generally associated with NAFLD/NASH.

NAFLD prevalence in general population is estimated to be 20-30% in the Western world (Masarone et al, Rev Recent Clin Trials, 2014)
By 2020, prevalence of NAFLD cirrhosis is set to overtake hepatitis B and hepatitis C related cirrhosis (Starley et al, Hepatol, 2010)
The NASH market could peak at $30-40 billion by 2025 (Deutsche Bank industry report, “NASH – the next big global epidemic in 10 years?”, 2014)


 
                                                                                                       
 
               
 

 

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LPCN News: Lipocine shares up after LPCN 1144 preclinical study results 03/04/2021 08:26:01 AM
LPCN News: Lipocine Announces Publication in Journal of Endocrinological Investigation Highlighting the Potential of LPCN 1144 in the Tr... 03/04/2021 08:00:00 AM
LPCN News: Current Report Filing (8-k) 03/03/2021 08:03:37 AM
LPCN News: Lipocine Announces Presentations on TLANDO™ at ENDO 2021 Conference 03/03/2021 08:00:00 AM
LPCN News: Current Report Filing (8-k) 03/01/2021 08:12:56 AM
PostSubject
#724   Next March at the earliest LQMTinvestor2018 03/03/21 07:22:21 PM
#723   When does Tlando tentative FDA approval become full gi197845 03/03/21 10:19:25 AM
#722   When a catalyst comes as we shareholders believe, Vance 02/27/21 04:38:24 AM
#721   Yeah. I believe it's just the overall market grizzly2314 02/26/21 05:31:07 PM
#720   The drop in share price to below 1.62 gi197845 02/25/21 03:00:37 PM
#719   I've learned to interpret CEO speak: gi197845 01/29/21 02:02:32 PM
#718   Current O/S is 88,607,685. Got that number from Vance 01/29/21 10:37:00 AM
#717   I am looking at $10+ by end of year.. lakingsphan0427 01/27/21 11:49:14 AM
#716   Back to $2 and plenty of cash in Vance 01/26/21 04:09:32 PM
#715   looks like a good buying opportunity for LPCN... dealerschool2006 01/26/21 02:03:58 PM
#714   Well, the stock price is sure down now. gi197845 01/26/21 01:39:28 PM
#713   Offering just killed off the momentum.. I guess lakingsphan0427 01/26/21 12:22:45 PM
#712   ok give me 1.75 already jablome 01/26/21 10:54:30 AM
#711   Odd they think the stock is under pressure, Vance 01/26/21 01:13:33 AM
#710   https://seekingalpha.com/news/3654112-lipocine-under-pressure-on-launching-under gi197845 01/25/21 11:37:23 PM
#709   Future looks bright especially if they are favored lakingsphan0427 01/21/21 11:42:27 AM
#708   Can't blame ya for that, but as steady Vance 01/21/21 10:47:00 AM
#707   Lighten up my position into half today now lakingsphan0427 01/21/21 10:14:29 AM
#706   20k views, 117k subscribers.. yeah I'd say that's Vance 01/20/21 07:23:09 PM
#705   This could be the reason why LPCN is lakingsphan0427 01/20/21 04:54:20 PM
#704   Nice day today Vance about time.. up 20% lakingsphan0427 01/20/21 03:54:43 PM
#703   H.C. Wainwright sticks to their Buy rating for LPCN Vance 01/19/21 12:41:06 PM
#702   DD on LPCN from Reddit Vance 01/19/21 12:39:30 PM
#701   LPCN: LIPOCINE’S LIFT RESULTS: A COMPARISON WITH PEERS Vance 01/19/21 12:38:24 PM
#700   I agree Vance non whatsoever lakingsphan0427 01/14/21 03:13:46 PM
#699   There is literally no risk here, except of Vance 01/14/21 03:04:03 PM
#698   News today is further proof of upper handedness Vance 01/14/21 08:10:44 AM
#697   A number of different scenarios, and the odds Vance 01/13/21 09:02:02 AM
#696   Hey Vance, I believe Clarus and LIPO have a StonkMaster 01/13/21 08:21:30 AM
#695   Good info Vance.. lakingsphan0427 01/12/21 01:23:31 PM
#694   Thanks Vance. Hope you're right ! StonkMaster 01/12/21 12:50:23 PM
#693   Short sellers have been taunting active LPCN forums Vance 01/12/21 12:45:35 PM
#692   With the news we should be inching in lakingsphan0427 01/12/21 12:38:49 PM
#691   Could you explain please? TIA! StonkMaster 01/12/21 12:34:43 PM
#690   Shorts gotta cover & Clarus likely in the Vance 01/12/21 12:33:04 PM
#689   What in the world is keeping this price StonkMaster 01/12/21 10:24:40 AM
#688   Positive Phase 2 Results just out! Vance 01/12/21 08:10:46 AM
#687   Definitely gearing up for an increase in share Vance 01/11/21 06:19:07 PM
#686   Ibox updated.. lakingsphan0427 01/11/21 05:07:48 PM
#685   Patel mentioned in the webcast this morning that StonkMaster 01/11/21 03:23:07 PM
#684   Something is brewing its up 13%.. GO LPCN!! lakingsphan0427 01/11/21 03:21:55 PM
#683   It's all good.. Still a good sign nonetheless lakingsphan0427 01/11/21 11:57:39 AM
#682   Hey Laking, unfortunately I was wrong when I StonkMaster 01/11/21 11:56:39 AM
#681   LPCN is slowly trending up..NICE!!! lakingsphan0427 01/11/21 11:56:38 AM
#680   Per the conference: Vance 01/11/21 11:55:56 AM
#679   Awesome!!! This is the kind of moved that lakingsphan0427 01/11/21 11:54:59 AM
#678   I’d consider it routine but good if he LQMTinvestor2018 01/05/21 08:10:25 AM
#677   Yeah my apologies I jumped the gun! Thanks StonkMaster 01/05/21 08:09:52 AM
#676   He was just granted options that’s all LQMTinvestor2018 01/05/21 08:08:51 AM
#675   https://newsfilter.io/articles/4-form---statement-of-changes-in-beneficial-owner StonkMaster 01/05/21 05:46:02 AM
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