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Lipocine Inc (LPCN)

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Last Post: 5/18/2022 7:02:04 AM - Followers: 52 - 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)


 
                                                                                                       
 
               
 

 

LPCN
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LPCN News: Statement of Changes in Beneficial Ownership (4) 05/16/2022 02:45:28 PM
LPCN News: Current Report Filing (8-k) 05/12/2022 05:01:05 AM
LPCN News: Current Report Filing (8-k) 05/12/2022 05:00:46 AM
LPCN News: Lipocine Announces Positive LPCN 1144 NASH Open Label Extension Study Results 05/12/2022 04:00:00 AM
LPCN News: Quarterly Report (10-q) 05/09/2022 04:04:11 AM
PostSubject
#778   Clueless LQMTinvestor2018 05/18/22 07:02:04 AM
#777   Forward split then, lol. Shelf offering! Dilution! gi197845 05/18/22 01:09:01 AM
#776   Yes but that is the exact opposite of LQMTinvestor2018 05/16/22 11:37:23 PM
#775   Increasing authorized shares can have the same end gi197845 05/16/22 10:41:38 PM
#774   Increasing authorized shares is not a reverse split …. LQMTinvestor2018 05/16/22 06:35:13 PM
#773   There is no reverse split vote! LQMTinvestor2018 05/16/22 06:30:59 PM
#772   Yes, I'm voting to reverse split. gi197845 05/16/22 06:26:01 PM
#771   There is no reverse split vote …. LQMTinvestor2018 05/13/22 07:20:27 PM
#770   Dilution, reverse split, recession and bankruptcy. gi197845 05/10/22 01:00:41 PM
#769   Well, with the upcoming reverse split vote, if gi197845 04/29/22 01:41:21 PM
#768   I am amazed that LPCN is now 0.92. BesaoT35 04/26/22 12:37:47 PM
#766   "I" am always amazed when a small cap Pyramid2 04/02/22 06:25:42 PM
#765   This LPCN message board ROCKS!!! gi197845 03/29/22 04:30:01 PM
#764   https://youtu.be/AM4OR5jSxS0 RunninRobert 03/18/22 10:36:47 AM
#763   28 of march TLANDO pdufa, 10th march financials, MF2 02/20/22 06:26:22 AM
#762   28 march pdufa for TLANDO and 10th sec MF2 02/20/22 06:21:33 AM
#761   Something, nothing, anything, everything! gi197845 01/16/22 09:45:51 PM
#760   You said ever thing and nothing. Perfect job done. everyonesguess 01/14/22 07:01:21 PM
#759   Yes, you are correct, in March 2022, Tlando gi197845 10/22/21 04:37:57 PM
#758   I remember that March 2022 is when the BesaoT35 10/12/21 10:40:53 AM
#757   Shart!!! gi197845 09/07/21 02:52:48 PM
#755   If the news was good with the NASH BesaoT35 08/26/21 12:09:05 PM
#754   Well the NASH news is out and the gi197845 08/26/21 12:19:10 AM
#753   Any time this month LQMTinvestor2018 08/08/21 09:42:51 PM
#752   When are we expecting NASH data? Thanks. BesaoT35 08/08/21 03:28:44 PM
#751   Someday this stock price will either go up gi197845 07/28/21 11:13:59 PM
#750   It's going to be a win win. gi197845 07/21/21 04:16:15 PM
#749   Do'h! gi197845 07/15/21 11:43:24 AM
#748   Actually things look pretty darn good! Lawsuit aside, Vance 06/08/21 02:25:36 PM
#747   Yes, things don't look good for Lipocine or gi197845 05/26/21 11:16:38 AM
#746   https://ih.advfn.com/stock-market/NASDAQ/lipocine-LPCN/stock-news/85206412/claru Rapier1911 05/26/21 08:03:57 AM
#745   Quite the range today, 1.25 to 1.56. gi197845 05/11/21 12:22:17 PM
#744   Correction, huge volume today. gi197845 05/11/21 10:30:40 AM
#743   Wow, big volume today. gi197845 05/11/21 10:11:45 AM
#742   Not yet Vance 05/06/21 05:34:46 PM
#741   Is there a date for the Clarus court case? BesaoT35 05/06/21 04:54:15 PM
#740   Do'h @ 1.38 now... gi197845 05/05/21 02:45:07 PM
#739   Are you still long on LPCN? Vance 04/29/21 09:59:05 PM
#738   I wonder what the results of the court gi197845 04/20/21 01:40:55 PM
#737   It's a pretty substantial drop from 1.47 to gi197845 04/19/21 12:47:42 PM
#736   Thanks Vance, thus far I think it's been gi197845 04/15/21 05:37:33 PM
#735   You really ought to sell any shares you Vance 04/14/21 11:43:32 AM
#734   Before or after the r/s and dilution? gi197845 04/14/21 12:08:36 AM
#733   Ok, thanks Vance. gi197845 04/12/21 11:16:32 AM
#732   Yep, I'm Sure! There is No RS up Vance 04/11/21 11:48:15 PM
#731   Hi Vance, are you sure? gi197845 04/11/21 11:46:07 PM
#730   Nope, no mention whatsoever of any rs vote. Vance 04/11/21 11:40:34 PM
#729   Is there an upcoming reverse split vote in June? gi197845 04/11/21 11:19:24 PM
#728   Ok, those are some good thoughts and let's gi197845 04/01/21 02:14:56 PM
#727   Picked up more shares yesterday. I'm surprised there Vance 03/30/21 09:40:35 PM
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