Manish Kumar Clinical Trials & Results, Diabetic Foot Ulcer Therapeutics, Pharma Proff, Pipeline Analysis

Positive Clinical Trials are Responsible for the Growth of Diabetic Foot Ulcer Therapeutics Pipeline

A diabetic foot ulcer is an open sore or wound that occurs in approximately 15% of patients with diabetes and is commonly located in the bottom of the foot. People with diabetes are at higher risk of developing neuropathy as increased blood glucose levels lead to nerve damage. Poor blood circulation, hyperglycemia, and deprived nutrition are some other risk factors associated with the onset of diabetic foot ulcer.

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Symptoms of diabetic foot ulcer vary from person to person. Some of the commonly reported symptoms include numbness and tingling sensation, skin discoloration, blisters, and red streaks. The disease can be diagnosed by physical examination and imaging techniques including magnetic resonance imaging (MRI), radiography, and bone scan. Treatment of the disease includes surgical procedures such as shaving or excision of bone and the correction of various deformities to remove pressure from the affected area. Moreover, dead skin and tissue removal, blood glucose management, medication, and regular dressings are also help to manage diabetic foot ulcer.

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REGRANEX (Janssen Pharmaceuticals Inc.), a topically administered gel, is one of the marketed products indicated for the treatment of diabetic foot ulcer.

According to the research, most of the therapeutic drug candidates are being developed for topical administration. It has been found that topical route of administration is easy to use, non-invasive, and effective method of treatment, and also ensures high level of patient satisfaction.

In November 2018, Destiny Pharma plc and University of Southampton entered into a research collaboration to examine the use of Destiny Pharma plc’s novel XF compounds to prevent, control, and eradicate chronic clinical infections, including diabetic foot ulcer and cystic fibrosis. Similarly, in February 2016, Gemstone Biotherapeutics LLC licensed new wound-healing technology from Johns Hopkins University for the treatment of diabetic foot ulcer.

Some of the key players involved in the development of diabetic foot ulcer therapeutics include GlaxoSmithKline plc, Destiny Pharma plc, FirstString Research Inc., RHEACELL GmbH & Co. KG, Charsire Biotechnology Corp., ASKLEP Inc., Remedor Biomed Ltd., Janssen Pharmaceuticals Inc., and Biotec Pharmacon ASA.

Manish Kumar Clinical Trials & Results, Health, Pharma Proff, Pipeline Analysis, pleen Tyrosine Kinase Inhibitor Therapeutics

Pipeline Analysis of Spleen Tyrosine Kinase (Syk) Inhibitor Therapeutics

Spleen tyrosine kinase (Syk) is a protein that belongs to the family of tyrosine kinases with an ability to initiate the inflammatory responses, by connecting immune cell receptors to intracellular signaling pathways. Therefore, Syk is an attractive target for improving the symptoms related to acute and chronic inflammation. In addition, the role of protein is recognized as a promoter in various types of cancers ranging from leukemia to retinoblastoma.

Syk protein facilitates the phosphorylation of protein on tyrosines and also involves in the B cell antigen receptor (BCR) signalling pathways. There are several drugs that effectively inhibit the Syk kinase but the off-target effect is a limiting factor. Currently, there are various Syk inhibitors that prevent release of inflammatory cytokines in vitro and IgE-driven mast cell degranulation.

Levolta Pharmaceuticals Inc. is developing a drug candidate, that acts as Syk inhibitor for the treatment of immunological diseases. Rigel Pharmaceuticals Inc. is developing fostamatinib as a Syk inhibitor for the treatment of chronic immune thrombocytopenia and autoimmune hemolytic anemia. Hutchison China MediTech Limited is also developing HMPL-523 as a Syk inhibitor for the treatment of cancer indications. Some of the companies having pipeline of Syk inhibitor include Genosco Inc., Asana BioSciences LLC, and others.

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Manish Kumar Clinical Trials & Results, Hepatocyte Growth Factor Inhibitor Therapeutics, Pharma Proff, Pipeline Analysis

Hepatocyte Growth Factor (HGF) Inhibitor Therapeutics Pipeline Analysis

Hepatocyte growth factor (HGF) is secreted by human pancreatic stellate cells and present predominantly on cancer cells. Thus, HGF inhibitors has emerged as an effective therapy in preventing local tumor growth. Also, studies have demonstrated that HGF inhibitors are significantly more effective than Gemcitabine in inhibiting tumor angiogenesis and metastasis.

Studies have demonstrated that the HGF inhibitor can be a novel therapeutics that can be developed as a monotherapy or as combination therapy with RAS-RAF-MEK, AKT-mTOR, and EGFR inhibitors for the treatment of various human cancers. HGF inhibitors have shown potent antineoplastic effects in several clinical trials for the treatment of head and neck squamous cell carcinoma as HGF/c-Met pathway is directly involved in the development of a proliferative, invasive, and metastatic cancer.

AVEO Pharmaceuticals Inc. is in the process of developing Ficlatuzumab as a potent HGF inhibitor antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities for the treatment of squamous cell carcinoma of the head and neck and acute myeloid leukemia. Galaxy Biotech LLC, Daiichi Sankyo Company Limited, and Taiho Pharmaceutical Co. are some other companies having HGF inhibitor pipeline.

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The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with detailed analysis of pipeline and clinical trials. Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licencing, grants, technology and others.

Manish Kumar Clinical Trials & Results, Health, Mitochondrial-Based Therapeutics, Pharma Proff, Pipeline Analysis

Mitochondrial-Based Therapeutics to Witness Significant Growth due to Positive Clinical Results in the Coming Years

Mitochondria are the organelles found in cytoplasm of most eukaryotic cells. These are also known as power-house of the cell. Although, the gene expression of mitochondria has been poorly understood; however, it is very important to understand the same in the diseased patients. Several chronic diseases, such as Leigh’s disease, and Alper’s syndrome, occur due to the mutation in mitochondrial DNA (mtDNA), which alters mtDNA expression. Currently, there are no approved drugs for the treatment of diseases caused due to mtDNA mutation.

According to the research findings, majority of the drug candidates in the pipeline are being developed as a small molecule and synthetic peptides, to counteract the effect of mitochondrial-based diseases in body. These drug candidates have shown a positive-results in their Pre-Clinical and clinical studies.

It has been observed that many mitochondrial-based therapeutics are being granted various designation from the United States Food and Drug Administration (USFDA), and the European Commission. These milestones are helpful in accelerating the development of therapeutic molecular entity. For instance, in April 2018, Stealth BioTherapeutics Inc. announced that the USFDA granted Orphan Drug Designation to company’s frontrunner compound “Elamipretide”, to treat Barth syndrome and Leber’s hereditary optic neuropathy (LHON).

Some of the key players involved in the development of mitochondrial-based therapeutics include Khondrion BV, CohBar Inc., BioElectron Technology Corporation, Chondrial Therapeutics Inc., Immungenetics AG, Stealth BioTherapeutics Inc., Congenia S.r.l., Astellas Pharma Inc., and Novartis AG.

Mitochondrial-Based Therapeutics Pipeline Analysis

By Phase

By Molecule Type

By Route of Administration

By Company

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The report comprises of detailed pipeline analysis of mitochondrial-based therapeutics, analyzing the emerging therapies and their progress status in different phases of development. Comprehensive insights into the pipeline phase products has been provided with special focus on strategic development activities inclusive of collaboration and licensing information, drug designations, financing, grants, technological advancements, and patent. The report also contains competitive analysis and extensive information on monotherapies, combination therapies, targets and mechanism of action, and drug origin with relevance to mitochondrial-based therapeutics.

Manish Kumar Clinical Trials & Results, Glycogen Synthase Kinase 3 Beta Inhibitors Therapeutics Pipeline, GSK-3β, Pharma Proff, Pipeline Analysis

Glycogen Synthase Kinase 3 Beta (GSK-3β) Inhibitors Therapeutics Pipeline Analysis

Glycogen synthase kinase 3 beta (GSK-3β) is an attractive target for the treatment of psychiatric disorders and neurodegenerative diseases. Many GSK-3β inhibitors have been developed for the treatment of different central nervous system disorders. But, for an effective therapy, high IC50 values should be avoided and ATP-competition should be reduced during enzyme-compound binding. Studies suggested that ATP non-competitive GSK-3 inhibitors such covalent inhibitors and allosteric modulators are emerging as a promising approach with better efficacy and safety.

Despite of many GSK-3β inhibitors in clinical studies, many challenges still remains. In a clinical study, certain adverse events caused by off-target activity of GSK-3β inhibitors were determined after the screening of compounds that bind to the ATP-competitive binding site conserved across a broad range of kinases. Thus, there is an urgent need of development of GSK-3β inhibitors that can selectively target individual pathways and differentiate between the non-phosphorylated and phosphorylated GSK-3β.

Company like AMO Pharma Ltd. is in the process of developing AMO-02 as a small molecule which acts as a GSK-3β inhibitor for the treatment of congenital myotonic dystrophy.

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Manish Kumar Clinical Trials & Results, JAK Inhibitors Pipeline, Pharma Proff, Pipeline Analysis

Janus Kinase (JAK) Inhibitors Pipeline to Witness Significant Growth due to Positive Clinical Results in the Coming Years

JAK comprises four receptors JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2) which help in cytokine mediated signaling through the JAK/STAT pathway. There are two nearly identical phosphate transferring domains present in JAKs. The first domain demonstrates kinase activity while the other regulates the activity of the first via negative inhibition. The mutations in the JAK/STAT pathway leads to different medical conditions.

The JAK inhibitors work by blocking the cytokine mediated signaling via JAK/STAT pathway which plays an important role in immune regulation and growth.

The pipeline of JAK inhibitors is quite robust with drugs being developed in the Pre-Registration, Phase III, Phase II, Phase I, Pre-Clinical, and Discovery stage of development. Also, majority of the pipeline products are currently undergoing Phase II clinical studies.

According to the research findings, majority of the JAK inhibitors in the pipeline are being developed for oral administration. It has been observed that the oral route of medication is convenient, available in delayed or rapid release formulation, less risk of systemic infections, and inexpensive in nature, and also provides improved patient’s compliance. Moreover, the drugs administered by this route are less invasive and can be modified for extended release, thereby increasing the bioavailability. Also, administration of JAK inhibitors through oral route have shown promising results in the clinical studies.

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The companies developing JAK inhibitors have shown positive clinical results in the various phases of drug development. For instance, in January 2018, LEO Pharma A/S’s collaborator Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. announced the topline results from delgocitinib’s Phase III comparative study. The primary endpoints of the study were met and there were no clinically significant findings on safety and tolerability of delgocitinib within the treatment period. Similarly, Astellas Pharma Inc. in February 2018, announced results of two-Phase II trials on peficitinib wherein the drug demonstrated superiority over the placebo w.r.t the primary endpoints. Also, the safety profile of Peficitinib was found to be consistent.

In the wake of various strategic development activities, Theravance Biopharma Inc. and Janssen Global LLC signed an agreement in February 2018 to jointly develop and commercialize Phase I product, TD-1473. Similarly, Galapagos NV and Gilead Sciences Inc. in December 2015 signed a partnership agreement to develop and commercialize filgotinib for the treatment of rheumatoid arthritis and Crohn’s disease. Therefore, collaborating and partnering with other companies can help the current players in the pipeline to expand their drug portfolio for the treatment of diseases related to the JAK/STAT pathway.

Pfizer Inc., Eli Lilly and Company, Incyte Corporation, AbbVie Inc., Concert Pharmaceuticals Inc., Portola Pharmaceuticals Inc., Italfarmaco S.p.A, CTI BioPharma Corp., Theravance Biopharma Inc., Janssen Global LLC, and Galapagos NV are some of the companies involved in the development of JAK inhibitors.

Manish Kumar Clinical Trials & Results, Health, Pharma Proff, Pipeline Analysis, Turner Syndrome Therapeutics, Women health

Pipeline Analysis of Turner Syndrome Therapeutics

Turner syndrome is a chromosomal condition, which occurs when one of the two X chromosomes normally found in women is missing or incomplete. The disease alters the growth and development in females. The symptoms can vary among women who have Turner syndrome.

Women with this condition tend to be shorter than average and are usually unable to conceive a child because of an absence of ovarian function. Some other features of this condition are extra skin on the neck (webbed neck), heart defects and kidney problems, puffiness or swelling (lymphedema) of the hands and feet, and skeletal abnormalities.

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This condition occurs in about one in 2,500 female births worldwide, but is much more common among pregnancies that do not survive to term (miscarriages and stillbirths).

The drug candidates of Turner syndrome disease pipeline include, but are not limited to are Estradiol and Somatropin pegylated. Some of the companies having drugs in the Turner syndrome disease pipeline are Novo Nordisk A/S, GeneScience Pharmaceuticals Co. Ltd., and Polus Inc.

Manish Kumar Clinical Trials & Results, Health, Pharma Proff, Pipeline Analysis, Uterine Fibroids Therapeutics, Women health

Clinical Trials & Results on Uterine Fibroids Therapeutics

Uterine fibroids, also known as leiomyomas or myomas, are non-cancerous growths that develop from the muscle tissue of the uterus. The size, shape, and location of fibroids can vary greatly. They may be present inside the uterus on its outer surface, or within its wall, or attached to it by a stem-like structure.

A fibroid may remain very small for a long time and suddenly grow rapidly, or grow slowly over a number of years. It usually affects women between the age of 30 to 40 years, but can occur at any age.

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Uterine fibroids may have various symptoms, such as change in menstruation, anaemia, abdominal cramps, constipation, pain during sex, rectal pain, and difficulty urinating or frequent urination. It is diagnosed through ultrasonography, hysteroscopy, hysterosalpingography, and sonohysterography. Some medications are known to reduce heavy bleeding and painful periods, caused due to this condition.

The drug candidates in uterine fibroids disease pipeline include, but are not limited to, Elagolix, OBE2109, and Proellex. Some of the companies having drugs in the uterine fibroids disease pipeline are Neurocrine Biosciences Inc., Abbvie Inc., and ObsEva SA.

Manish Kumar Clinical Trials & Results, Pharma Proff, Pipeline Analysis, Wnt Signaling Pathway Inhibitors

Wnt Signaling Pathway Inhibitors to Witness Significant Growth due to Positive Clinical Results in the Coming Years

Wnt signaling pathway plays an important role in embryonic development. The signaling pathway regulates cell-to-cell interaction, accelerates trophoblast development, activates blastocyst, accelerate chorion-allantois fusion and implantation. A wide range of diseases, such as different types of cancer and degenerative diseases can be treated by deregulation of components involved in Wnt/β-catenin signaling pathway. Also, researchers have demonstrated that moderate weakening of Wnt signaling can eliminate its carcinogenic potential. Based on the recent researches, Wnt Signaling Pathway inhibitors have also shown potential in cardiovascular disorders.

According to the research findings, majority of the drug candidates in the pipeline are being developed to be administered by the oral route. It has been observed that oral route of medications is convenient; available in delayed or rapid release formulation; provides improved patient’s compliance; and has less risk of systemic infections. Administration of Wnt Signaling Pathway Inhibitors through oral route has shown promising results in the clinical studies. Also, according to the analysis, maximum number of drugs in the pipeline are being developed as small molecules.

The companies developing Wnt Signaling Pathway inhibitors for the treatment of cancer and degenerative diseases, have shown positive clinical results in the various phases of drug development. For instance, in October 2018, Samumed LLC, announced the topline data from the phase IIb trial SM04690 in knee osteoarthritis, wherein the treatment with SM04690 showed improvement in function, pain, and global scores of patients.

Some of the key players involved in the development of Wnt signaling pathway inhibitors in the late and mid stage include Samumed LLC, Can-Fite BioPharma Ltd., Tactical Therapeutics Inc., Leap Therapeutics Inc., 2X Oncology Inc., Eisai Co. Ltd., and Novartis AG.

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Manish Kumar Health, Pharma Proff, Tuberous Sclerosis Therapeutics

Tuberous Sclerosis Therapeutics- Pipeline Analysis 2018, Clinical Trials & Results

Tuberous sclerosis, also known as tuberous sclerosis complex, is a genetic disorder characterized by the growth of numerous noncancerous (benign) tumors in many parts of the body.

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It can occur in the brain, skin, kidneys, and other organs, in some cases leading to significant health problems. The signs and symptoms of the disease vary from person to person. Virtually all affected people have skin abnormalities, including patches of unusually light-coloured skin, areas of raised and thickened skin, and growths under the nails. It can also cause facial angiofibromas, tumors on the face beginning in childhood.

Some affected children have the characteristic features of autism, a developmental disorder that affects communication and social interaction.

The drug candidates of tuberous sclerosis disease pipeline include, but not limited to, cannabidiol, and TAK-935. Novartis AG, GW Pharmaceuticals plc and Takeda Pharmaceutical Company Limited are some of the major companies having drugs in the tuberous sclerosis therapeutics pipeline.