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A scale and fat cells Taylor Tieden for BioSpace In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. The global obesity market is forecasted to reach between $100 billion and $160 billion in the next decade. Meanwhile, the market for type 2 diabetes, which is closely related, is predicted to exceed $70 billion by 2032. There is thus considerable opportunity for Novo Nordisk, Eli Lilly, Pfizer and the multitude of other biopharma companies vying for a piece of the lucrative pie. Weight-Loss Market Estimates and Projections Source: IQVIA, Reuters, Goldman Sachs Taylor Tieden for BioSpace While exceedingly successful, many suspect the current GLP-1 injection therapies for obesity will ultimately be replaced by oral GLP-1 drugs, and several companies, including Lilly, Novo and Pfizer, are racing to bring their versions to the market. In addition, the space is not limiting itself to GLP-1s but is also exploring novel mechanisms to tackle these widespread diseases. Here, BioSpace examines the current obesity and diabetes markets along with the growing pipelines that aim to serve them. Weight Loss: A Two-Horse Race The obesity market is currently dominated by two companies: Novo Nordisk and Eli Lilly. While Novo’s obesity drug Wegovy had a two-year head start on Lilly’s Zepbound, the latter is making up ground . On August 7, Novo reported its second-quarter earnings , revealing profits of $1.7 billion for Wegovy and $4.23 billion for diabetes drug Ozempic. Despite growth rates of 53% and 30%, respectively, for the drugs, investors were not impressed because analyst forecasts were missed. Lilly, on the other hand, beat Q2 expectations , bringing in $1.24 billion for Zepbound and $3.1 billion for diabetes treatment Mounjaro. But the future is much more than a two-horse race. Several companies, including Pfizer , Roche , Viking Therapeutics , and Rivus Pharmaceuticals, are developing obesity therapeutics. Some leverage the GLP-1 pathway, while others commit to different mechanisms, including amylin analogs and mitochondrial uncoupling. Other players in the space include Veru Pharmaceuticals, Regeneron, Altimmune, Amgen, and Amylyx. Approval Timeline The obesity space truly caught fire with the clinical success of Wegovy and Zepbound, but these products follow several other treatments for obesity and diabetes approved over the past two-plus decades. Here is a sampling of noteworthy products. November 2023 Eli Lilly, Zepbound Generic name: Tirzepatide Treatment: Weight management June 2022 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in pediatric patients May 2022 Eli Lilly, Mounjaro Generic name: Tirzepatide Treatment: Type 2 diabetes June 2021 Novo Nordisk, Wegovy Generic name: Semaglutide Treatment: Obesity December 2020 Novo Nordisk, Saxenda Generic name: Liraglutide Treatment: Obesity in adolescents September 2019 Novo Nordisk, Rybelsus Generic name: Semaglutide Treatment: Type 2 diabetes (pill form) December 2017 Novo Nordisk, Ozempic Generic Name: semaglutide Treatment: Type 2 diabetes September 2014 Takeda, Contrave Generic names: Naltrexone and bupropion Treatment: Weight loss July 2012 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in adult patients January 2010 Novo Nordisk, Victoza Generic name: Liraglutide Treatment: Type 2 diabetes April 2005 Amylin Pharmaceuticals, Byetta Generic name: Exenatide Treatment: Type 2 diabetes The Highly Sought Weight-Loss Pill In 2019, the FDA approved Novo’s Rybelsus as the first oral GLP-1 for type 2 diabetes. Considered by many to be the next frontier in obesity treatment, oral medicines are under development by a number of companies, including Novo, whose amycretin is in Phase I trials, and Lilly, which has a Phase III trial underway for orforglipron. Brazilian owned multinational company Eurofarma also has a Phase III study underway for its oral candidate sibutramine/topiramate XR. Meanwhile, a host of companies have oral assets in earlier-stage trials. Pfizer recently announced that it would move forward with a modified-release formulation of its candidate danuglipron, and in December 2023, San Francisco–based Structure Therapeutics announced positive results from a Phase IIa trial of its weight-loss pill GSBR-1290. Note: Not all companies with oral medicines in Phase I and II trials are included. Taylor Tieden for BioSpace Widely hailed as “the next big thing” in the obesity space, several companies—including Eli Lilly, Novo Nordisk and Pfizer—are developing oral GLP-1 candidates. How long before oral GLP-1s take majority share of the market? Source: BioSpace LinkedIn poll , August 2024 Taylor Tieden for BioSpace This deep dive was originally published as a special edition of ClinicaSpace. Subscribe here .

First-in-human trial initiation in MS patients is imminentWATERTOWN, Mass., Aug. 22, 2024 (GLOBE NEWSWIRE) -- Abata Therapeutics, a company focused on transforming lives with Treg therapies for severe autoimmune and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101’s Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase 1 study is imminent. “There are no effective treatments for progressive MS, and rapidly advancing new therapies is critical for patients and their families. We are very pleased that the FDA granted us Fast Track designation as it will enable us to expedite our efforts to bring ABA-101 to patients,” said Samantha Singer, M.S., M.B.A., president and chief executive officer of Abata. “We are focused on initiating our Phase 1 study this year in patients and evaluating the potential impact of this important new therapy.” The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the ultimate goal of getting important new drugs to patients earlier. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval, which may lead to earlier drug approval and access for patients. A drug receiving Fast Track designation also may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. About ABA-101 and Progressive Multiple SclerosisABA-101 is Abata’s autologous Treg therapy in development for the treatment of progressive multiple sclerosis. It was specifically designed for MS patients with progressive disease who have imaging evidence of ongoing inflammatory tissue injury and are HLA-DRB1*15:01 positive – an estimated patient group of about 45,000 in the U.S. today. ABA-101 is created by engineering a patient’s own Tregs to express a T cell receptor (TCR) that specifically recognizes immunogenic myelin fragments in the CNS. This approach was designed to offer a strong safety profile and a highly localized anti-inflammatory effect at the site of disease. In in vivo preclinical studies, ABA-101 was well-tolerated and demonstrated antigen-dependent Treg functionality, anti-inflammatory cytokine production, suppression of the production of inflammatory cytokines and therapeutic effect. About Abata TherapeuticsAbata Therapeutics is dedicated to transforming lives with Treg therapies for severe autoimmune and inflammatory diseases. Founded by pioneers in Treg biology, TCR and antigen discovery, disease pathogenesis, and molecular and imaging biomarkers, Abata has developed a differentiated product engine to create engineered Treg cell therapies that are tissue-specific, robust, and durable. Abata’s lead program in progressive MS is on track to initiate a Phase 1 study in 2024, and its second program in type 1 diabetes is in IND-enabling studies. Both indications are tissue-specific autoimmune diseases with substantial unmet need, supporting a strong rationale for Abata’s Treg approach. The company was launched in 2021 by Third Rock Ventures, and today is supported by a diverse syndicate of investors, including Lightspeed Venture Partners, Biogen, Bristol Myers Squibb, ElevateBio, Eurofarma, Invus, Samsara BioCapital, and T1D Fund (formerly JDRF T1D Fund). Abata is based in Watertown, Mass. Please visit abatatx.com or follow us on X (formerly known as Twitter) or LinkedIn for more information. Media ContactCory TrombleeScient PRcory@scientpr.com Investor ContactCourtney MogerleyPrecision AQCourtney.Mogerley@precisionAQ.com

Aug. 15, 2024 -- Abata Therapeutics, a company focused on transforming lives with Treg therapies for severe autoimmune and inflammatory diseases, today announced it has received an equity investment from Bristol Myers Squibb to support the development of its Treg cell therapy products. Their investment supports Abata's continued advancement into the clinic, with trial initiation imminent for ABA-101 in progressive multiple sclerosis. “Given their leadership in cell therapy, immunology, and neuroscience, we’re honored to have Bristol Myers Squibb as an investor. This investment highlights both the potential of our product engine and a shared belief in the transformational potential of TCR targeted Treg cell therapies for the treatment of autoimmune and inflammatory diseases,” said Samantha Singer, M.S., M.B.A., President and Chief Executive Officer of Abata. “The support of Bristol Myers Squibb adds not only capital, but also expertise as we advance our two lead programs, ABA-101 for the treatment of progressive multiple sclerosis and ABA-201 for the treatment of type 1 diabetes.” Abata Therapeutics is dedicated to transforming lives with Treg therapies for severe autoimmune and inflammatory diseases. Founded by pioneers in Treg biology, TCR and antigen discovery, disease pathogenesis, and molecular and imaging biomarkers, Abata has developed a differentiated product engine to create engineered Treg cell therapies that are tissue-specific, robust, and durable. Abata’s lead program in progressive MS is on track to initiate a Phase 1 study in 2024, and its second program in type 1 diabetes is in IND-enabling studies. Both indications are tissue-specific autoimmune diseases with substantial unmet need, supporting a strong rationale for Abata’s Treg approach. The company was launched in 2021 by Third Rock Ventures, and today is supported by a diverse syndicate of investors, including Lightspeed Venture Partners, Biogen, Bristol Myers Squibb, ElevateBio, Eurofarma, Invus, Samsara BioCapital, and T1D Fund (formerly JDRF T1D Fund). Abata is based in Watertown, Mass. Please visit abatatx.com or follow us on X (formerly known as Twitter) or LinkedIn for more information. The content above comes from the network. if any infringement, please contact us to modify.