Obesity - Pipeline Insights, 2022

Obesity - Pipeline Insights, 2022

DelveInsight’s, “Obesity - Pipeline Insight, 2022,” report provides comprehensive insights about 100+ companies and 130+ pipeline drugs in Obesity pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

Global coverage

Obesity Understanding

Obesity: Overview

Obesity is recognized as a chronic or noncommunicable disease, a complex, multifactorial phenotype, affecting, along with overweight, primarily associated with excess adiposity or body fatness which can manifest metabolically and not just concerning the size of the body. Unwanted body weight gain leading to obesity and overweight has become the main driver of the global rise in noncommunicable diseases; therefore, it is considered a noncommunicable disease. Because of the psychological and social stigma associated with being overweight and obese, those affected are also vulnerable to discrimination in their personal and work lives, low self-esteem, and depression. Childhood obesity results in the same comorbidities as obesity, with premature onset or greater likelihood in adulthood. The medical and psychological sequel of obesity contributes to a major threat to the socioeconomic healthcare burden, which is striking.

According to the World Health Organization (WHO), obesity is an abnormal or excessive accumulation of fat or adipose tissue in the body that presents a health risk. The body mass index (BMI) is used to define obesity, which is calculated as weight (kg)/height (m2). A person with a BMI greater than or equal to 30 is considered obese. It is the second most common cause of preventable death, which is associated with the risk of developing inflammatory components, directly and indirectly, related to cardiovascular disease, diabetes mellitus, respiratory problems, psychological issues, hypertension, obstructive sleep apnea, cancer, and hyperlipidemia. It imposes a significant public health epidemic that has progressively worsened over the past semi-centennial. An increase in obesity has been observed in children and adults of both genders and is prevalent in both developed and developing countries.

""Obesity - Pipeline Insight, 2022"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Obesity pipeline landscape is provided which includes the disease overview and Obesity treatment guidelines. The assessment part of the report embraces, in depth Obesity commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Obesity collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Obesity R&D. The therapies under development are focused on novel approaches to treat/improve Obesity.

In September 2021, D&D Pharmatech, Inc., announced that Shenzhen Salubris Pharmaceuticals has acquired the rights to develop and commercialize DD01 in mainland China. D&D will retain all rights for the rest of the world. In connection with this agreement, D&D was to receive an upfront payment of $4 million and was also eligible to receive additional undisclosed milestone payments upon achievement of certain development and commercial milestones, as well as double-digit royalties on future net sales.

In June 2021, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), and SCOHIA PHARMA, Inc, entered into a strategic collaboration to develop, manufacture and commercialize SCO-094, a GLP-1R and GIPR dual agonist treating diabetes, obesity and other metabolic diseases, in 25 countries in Asia Pacific region, including China, South Korea, and Australia, except Japan.

Obesity Emerging Drugs Chapters

This segment of the Obesity report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Obesity Emerging Drugs

Semaglutide oral: Novo Nordisk

Oral semaglutide (7 mg and 14 mg) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in the US, EU, and Japan under the trade name, Rybelsus. The approval of Rybelsus is based on the results from 10 clinical trials, which included 9,543 adults with type 2 diabetes. Oral semaglutide received FDA approval in September 2019 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The product is available in 3, 7, and 14 mg tablets. Rybelsus demonstrated a safe and well-tolerated profile across the clinical trials, with the most common adverse event being mild-to-moderate nausea, which diminished over time.

GLP-1 receptor agonists lower glycemia via several mechanisms, including stimulating glucose-dependent insulin secretion from pancreatic β cells, suppressing glucagon secretion from pancreatic α cells, and delaying gastric emptying. The novelty of oral semaglutide is in the formulation that allows for oral administration and absorption of the drug. Oral semaglutide is coformulated with the absorption enhancer sodium N-(8-[2-hydroxylbenzoyl] amino) caprylate (SNAC). Currently, it is being evaluated in a Phase III clinical trial to treat obesity.

Tirzepatide: Eli Lilly and Company

Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. In preclinical models, GIP decreases food intake and increases energy expenditure, resulting in weight reductions. Combined with GLP-1 receptor agonism, it may have greater effects on markers of metabolic dysregulation such as body weight, glucose, and lipids. Tirzepatide is in Phase III development for adults with obesity or overweight with weight-related comorbidity and is currently under regulatory review as a treatment for adults with type 2 diabetes. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH) and heart failure with preserved ejection fraction (HFpEF). Studies of tirzepatide in obstructive sleep apnea (OSA) and morbidity/mortality in obesity are also planned.

Tesomet: Saniona

Tesomet combines two active ingredients: tesofensine and metoprolol. Tesofensine is a novel, proprietary molecule developed in the labs of Saniona’s founding scientists. It works in the brain to block the reabsorption of three monoamine neurotransmitters: serotonin, noradrenaline, and dopamine. Blocking reuptake increases the level of these neurotransmitters in the brain, which reduces food cravings, reduces appetite, and increases metabolic fat burn.

When administered alone, tesofensine has been shown in clinical studies to reduce weight while being generally well-tolerated. However, some doses increase heart rate and/or blood pressure. Tesomet combines tesofensine with metoprolol, a generic medicine used to treat hypertension, angina pectoris, and heart failure. The Tesomet combination has demonstrated a significantly improved cardiovascular safety profile compared to tesofensine alone. Saniona’s Phase IIb trials of Tesomet in hypothalamic obesity and Prader–Willi syndrome have been voluntarily paused due to funding limitations; this pause is not related to the safety or efficacy of Tesomet.

RZL-012: Raziel Therapeutics

Raziel Therapeutics is a clinical-stage pharmaceutical company developing RZL-012, an injectable treatment for aesthetics and fat disorders. A single treatment session in which RZL-012 is injected into subcutaneous fat, results in a significant and sustained reduction in fat volume. RZL-012 is a novel synthetic small molecule that kills fat cells when injected into subcutaneous fat. It is the first and only injectable drug that significantly and sustainably shrinks Lipomas’ size in Dercum’s disease, reducing abdominal fat volume (body contouring) and submental fullness (double chin).

In in vitro studies, RZL-012 reduced the ability of fat cells to accumulate or store fat. RZL-012 is administered by several injections delivered in a single injection session. Once injected, RZL-012 triggers immediate fat cell death, followed by a transient inflammatory process that lasts about a month, during which necrotic fat tissue is replaced by fibrotic tissue. This results in a significant long-term, sustained shrinkage of fat tissue. Raziel therapeutics evaluates RZL-012 in Phase II clinical trial in treating obesity.

CT-868: Carmot Therapeutics

CT-868 is a dual GLP-1 and GIP receptor modulator with a unique pharmacological profile optimized for improved tolerability at the GLP-1 receptor. The combined action of GLP-1 and GIP results in greater body weight loss and glucose control. CT-868 is dosed once daily to maximize efficacy and tolerability. CT-868 dual agonist candidate was discovered using the chemotype evolution technology as a peptide-small molecule hybrid compound, able to mimic the native GLP-1 hormone.

In the Phase I trial, CT-868 demonstrated compelling pharmacodynamic activity across several clinical measures in overweight and obese healthy individuals a safe and generally well-tolerated profile. Carmot Therapeutics is now expanding the observations in overweight and obese patients with type 2 diabetes to demonstrate CT-868’s effects on glycemic control, weight loss, and tolerability. Currently, the product is in the Phase II stage of development to treat obesity

EMP16: Empros Pharma

Empros Pharma has developed a revolutionary drug – EMP16. The main mechanism of action for EMP16 is to delay normal food digestion and absorption processes toward the end of the small intestine. EMP16 is based on a proprietary advanced drug delivery technology designed to have features that optimize its effect throughout the gastrointestinal system. EMP16 is an oral product with a local effect on the gastrointestinal system. It is a fixed dose combination of two locally active, safe, and established active drugs (orlistat and acarbose). The advanced multiple-unit, the modified-release formulation is designed to maximize the drug’s effect and improve tolerability. Empros Phase IIa trial has demonstrated a best-in-class safety profile and potentially improved effect compared to XENICAL. EMP16-01 can potentially be a safe and effective treatment of obese and overweight children and adults with and without reduced glucose control. Due to its excellent safety profile, overweight children and adults with decreased glucose tolerance, “pre-diabetic” and/or “pre-obese” could be a big additional treatment group as there are currently no relevant (and safe) products available. Empros Pharma conducted a Phase II study to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (EMP16) on relative body weight after 26 weeks compared with placebo.

DD01: D&D Pharmatech

DD01 is a proprietary, imbalanced dual agonist of GLP-1 and glucagon receptors with a half-life of 11 days in non-human primates. DD01 is being developed as a potential disease-modifying agent for obesity and liver fatty disease. Treatment with DD01 caused weight loss, reduced liver fat, and improved glucose tolerance in preclinical obesity, diabetes, and fatty liver models. In preclinical models of diabetes and nonalcoholic fatty liver disease (NAFLD), DD01 could reduce weight and blood sugar and improve insulin sensitivity and lipid and fat metabolism, which could ameliorate NASH. DD01 demonstrated greater efficacy in preclinical models than semaglutide, an approved GLP-1R receptor agonist; from a mechanical perspective, the effect of DD01 persisted after cessation of treatment. It is currently being evaluated in Phase I clinical trial to investigate the safety, tolerability, PK, and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD).

ZP 8396: Zealand Pharma

ZP8396 is an investigational, potent long-acting amylin analogue designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP-1 analogues. In preclinical studies ZP8936 has shown potent anti-obesity effects. The Phase I, First-In-Human, randomized, single ascending dose trial, will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP8396 administered to healthy subjects.

ERX-1000: ERX Pharmaceuticals

ERX-1000, a first-in-class leptin sensitizer, is developing to treat obesity and related diseases. Using a systems-biology approach, ERX scientific co-founder Dr. Umut Ozcan identified ERX-1000, a first-in-class leptin sensitizer. While ERX-1000 is highly effective at reducing appetite and decreasing weight in diet-induced obese mouse models (an experimental model of human obesity), it does not have any effect on leptin-deficient obese mice, obese mice lacking leptin signaling (genetically deficient in leptin or its receptor), or non-obese mice, demonstrating that ERX-1000 is a true leptin sensitizer.

Further product details are provided in the report……..

Obesity: Therapeutic Assessment

This segment of the report provides insights about the different Obesity drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Obesity

There are approx. 100+ key companies which are developing the therapies for Obesity. The companies which have their Obesity drug candidates in the most advanced stage, i.e. Phase III include, Novo Nordisk.

Phases

DelveInsight’s report covers around 130+ products under different phases of clinical development like

Late stage products (Phase III)

Mid-stage products (Phase II)

Early-stage product (Phase I) along with the details of

Pre-clinical and Discovery stage candidates

Discontinued & Inactive candidates

Route of Administration

Obesity pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

Oral

Parenteral

intravenous

Subcutaneous

Topical.

Molecule Type

Products have been categorized under various Molecule types such as

Monoclonal Antibody

Peptides

Polymer

Small molecule

Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Obesity: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Obesity therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Obesity drugs.

Obesity Report Insights

Obesity Pipeline Analysis

Therapeutic Assessment

Unmet Needs

Impact of Drugs

Obesity Report Assessment

Pipeline Product Profiles

Therapeutic Assessment

Pipeline Assessment

Inactive drugs assessment

Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

How many companies are developing Obesity drugs?

How many Obesity drugs are developed by each company?

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Obesity?

What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Obesity therapeutics?

What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?

What are the clinical studies going on for Obesity and their status?

What are the key designations that have been granted to the emerging drugs?

Key Players

180 Life Sciences

9 meters

Aardvark Therapeutics

Adocia

Agentix

AgeX Therapeutics

Altimmune

Amgen

Antag Therapeutics

Aphaia Pharma

Aptorum Group

AstraZeneca

Betagenon AB

BioRestorative

BioRestorative Therapies

Boehringer Ingelheim

Braasch Biotech

Bristol-Myers Squibb

Bukwang Pharmaceutical

Caliway Biopharmaceutics Co Ltd

Can Fite Biopharma

Carmot Therapeutics

Carmot Therapeutics, Inc.

Cellivery Therapeutics Inc

CinFina

CinFina Pharma

Clayton Biotech

Click Therapeutics

CohBar

Corbus Pharma

CSPC Baike (Shandong) Biopharmaceutical

D&D Pharmatech

D&D Pharmatech Co Ltd

Daewoong Pharmaceutical

DiscoveryBiomed Inc

Dong-A ST

Dongkook Pharmaceuticals

Eccogene

Elevian

Eli Lilly and Company

Empros Pharma

Enterin Inc.

EraCal Therapeutics AG

ERX Pharmaceuticals

ERX Pharmaceuticals

Eternygen GmbH

Eurofarma

Gannex Pharma

Glaceum

Gmax Biopharm

GPER G-1 Development Group, LLC

Gubra Therapeutics

Hanmi Pharmaceutical

Hanmi Pharmaceuticals

Innovent Biologics

Jenrin Discovery

Jiangsu Hansoh Pharmaceutical

Kallyope

Kintai Therapeutics

Kriya Therapeutics

LG Life Sciences

Lipidio Pharmaceuticals

MakScientific

Nano Precision Medical

NeonMind Biosciences

Novartis

Novo Nordisk

NuSirt Biopharma

Otsuka Pharmaceutical Factory Inc

Paige Biopharmaceutical (Suzhou) Co., Ltd.

Pfizer

Preveceutical Medical Inc

Pylum Biosciences

Raziel Therapeutics

Reata Pharmaceuticals

Regeneron Pharmaceuticals

Reviva Pharmaceuticals

Rivus Pharmaceuticals

RosVivo Therapeutics

Saniona

SciSparc Ltd.

Sciwind Biosciences

SCOHIA PHARMA

Shionogi

SHIONOGI & Co., Ltd.

Sigrid Therapeutics

SJT Molecular Research SL

Structure Therapeutics

Sun Pharmaceutical Industries

Techfields Pharma

Terns Pharmaceuticals

Tonix Pharmaceuticals

UGISense AG

Versanis Bio

Viking Therapeutics

YSOPIA Bioscience

Yuhan

Zealand Pharma

Key Products

Semaglutide Oral

Tirzepatide

Sibutramine/Topiramate

NNC0174-0833

Tesomet

SHR-20004

RZL-012

CT-868

PF-06882961

EMP-16

S-237648

LY3502970

ARD-101

NNC0165-1875

XW003

IBI362

TG103

Cotadutide

MBL949

PF-07081532

APHD-012

LY 3437943

HSG4112

Leucine/sildenafil

BI 456906

Pemvidutide

LY3841136

HM15136

GMA106

DD01

ZP8396

K833

NNC0480-0389

NNC0480-0389

LB54640

CT-181

CB4211

CT-388

CIN-109

ERX-1000

DWP306001

SCO-094

S-309309

NO-13065

GDD3898

XW004

SCO-267

ASC41

AMG 133

GSBR-1290

K757

BI 1356225

Bardoxolone methyl

LY3541105

AMG-786

HU6

BMS-963272

BI 1820237

Xla 1

Dapiglutide

PB-119

PB-718

AGTX-2004

ECC5004

Thermostem

XW017

HM 14320

TNX-2900

CF-102

XW 010

LR19020

LR19056

Small Molecule

YH34160

NM-136

Rsearch programme: Obesity

DA-1726

Era-379

Research programme: NaCT inhibitors

CIN 110

CIN 209

CIN 210

RSVI-301

PramExe

BC GlueExe

BC Pram GlueExe

AGEX BAT1

Obesity Research project

CLS-1

O304 AMPK Activators

Obesity Research project

Novel vaccine Obesity Research project

CV-08

HI P. Goldsteinii

CRB-913

Tespria

Next Generation Candidates

AM 6545

LP-003

KT A522

JD5037

Research program: Amylin targeting

Obesity research program

Dual Gene Therapy program

RP 1208

SiPore® platform based therapy

SJT4a

GL0034

TF0103

TERN-601

NEO-001

KTX 0200

ENT-03

Bimagrumab

VK2735

Recombinant growth differentiation factor 11

HUM-234

NPM 139

YHC2129

YHC2134

YHC1140

GSBR-2nd Gen

GSBR-3rd Gen