Eidos Therapeutics, Inc.

Dyslipidemia, a condition involving unhealthy levels of cholesterols and other fats in the blood, is a major risk factor in cardiovascular diseases, which make up the world’s biggest killer with 17.9 million deaths ​ per year. While there are treatments for dyslipidemia, they are not sufficient to control the blood levels of low-density lipoprotein cholesterol, or ‘bad cholesterol,’ in many patients. The oral drug developed by CSPC is designed to prevent the production of a low-density lipoprotein called lipoprotein (a), which is involved in the transport of cholesterol in the bloodstream. By doing this, it may treat and prevent a range of cardiovascular diseases as a monotherapy or in combination with another small molecule candidate by AstraZeneca’s that depletes low-density lipoproteins by blocking an enzyme called PCSK9. According to the deal terms, CSPC is eligible for $100 million upfront in addition to up to $1.92 billion in payments based on development and commercialization milestones, plus tiered royalties. Sharon Barr, AstraZeneca’s executive vice president and head of biopharmaceuticals R&D stated ​ that the asset “could help patients to more effectively manage their dyslipidemia and related cardiometabolic diseases. Given the scale of unmet need, with cardiovascular disease being a leading cause of death globally, advancing novel therapies that can be used alone or in combination to effectively address known risk factors and advance patient care is particularly important and a key part of our strategy.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); The global market for cardiovascular disease treatments was worth a massive $144 billion in 2023 ​ and is projected to grow by 4% per year to $208 billion by 2030. The market growth is being fuelled by increasingly sedentary lifestyles across the population, leading to higher prevalences of cardiovascular diseases in both young and old people. This is the latest deal showcasing major interest from big pharma companies in cardiovascular disease treatments. AstraZeneca kicked off 2023 with a $1.8 billion takeover of the U.S. drug developer CinCor. Other examples include Novo Nordisk’s takeover of the German player Cardior Pharmaceuticals for up to €1 billion ($1.1 billion) in March this year and Bayer acquiring the European marketing rights to a small molecule cardiovascular disease treatment from Eidos Therapeutics of the U.S. for up to $310 million upfront in the same month. AstraZeneca also has major interest in the field of obesity, having inked another $2 billion licensing deal with China’s Eccogene last year for global rights to the latter’s oral once-daily glucagon-like peptide 1 receptor agonist.

BridgeBio Pharma has transferred several preclinical and early clinical-stage drugs to a new company, GondolaBio, thats drawn $300 million in promised investment from a syndicate of blue-chip life sciences investors.Viking Global Investors, Patient Square Capital and Frazier Life Sciences are among the investors backing GondolaBio, according to a Wednesday securities filing from BridgeBio. Also involved is an entity owned by BridgeBio CEO Neil Kumar.The Palo Alto, California biotechnology company will initially hold a 45% stake in GondolaBio, although that will go down as additional capital commitments are funded. The new company will inherit drug programs aimed at the rare diseases erythropoietic protoporphyria, alpha-1 antitrypsin deficiency and tuberous sclerosis complex.BridgeBio has already slimmed its pipeline down once this year, spinning out a slate of experimental cancer drugs into a new company called BridgeBio Oncology Therapeutics. The company has long operated on a hub-and-spoke model, functioning as a parent for biotech subsidiaries. It previously launched QED Therapeutics and Adrenas Therapeutics, and several years ago reacquired another, Eidos Therapeutics, that it formed in 2017.The agreement creating GondolaBio was recommended by a committee of independent and disinterested directors to BridgeBios board, which approved it. The company did not return BioPharma Dives request for further information on GondolaBio beyond the details enclosed in the securities filing.Also committing to invest in GondolaBio are Sequoia Capital, Cormorant Asset Management and Aisling Capital.BridgeBios chief asset is a heart drug called acoramidis, which succeeded in Phase 3 testing last year. An approval application is currently under review in the U.S., with a decision expected by late November. '

AstraZeneca (AZ) has shared positive high-level results from a late-stage trial of acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a rare and progressive condition that leads to heart failure and high rates of mortality within four years of diagnosis. In ATTR-CM, the transthyretin (TTR) protein that normally circulates in the bloodstream becomes misshapen and builds up in various parts of the body, including the heart, resulting in cardiomyopathy. Up to 500,000 people worldwide are affected by the condition, but many of those patients remain undiagnosed, AZ said. Acoramidis is an investigational, next-generation oral small-molecule stabiliser of TTR, designed to achieve maximal stabilisation and preserve native TTR. Results from the phase 3 trial of the candidate, conducted in Japan, showed consistency with those in the global BridgeBio Pharma ATTRibute-CM phase 3 study, including survival, cardiac-related hospitalisations and other measures of improved functions and quality of life at 30 months. Acoramidis was well-tolerated, AZ said, adding that the new results will be submitted for regulatory review in Japan, where the company’s rare disease unit, Alexion, maintains an exclusive licence with BridgeBio’s affiliate, Eidos Therapeutics, to develop and commercialise the asset. Marc Dunoyer, chief executive officer of Alexion, said: “With one of the industry’s largest amyloidosis pipelines exploring multiple therapeutic modalities, we are working to redefine treatment and care as well as offer new hope for this underserved community.” Professor Yukio Ando, department of amyloidosis research, Nagasaki International University, added: “As people living with ATTR-CM are at risk of significant morbidity and mortality, including heart failure, halting disease progression is essential to improving outcomes. "These results offer further evidence that TTR stabilisation with acoramidis may improve survival and reduce disease severity for patients by preventing further breakdown of these proteins.” The results come just two weeks after AZ announced positive data from a late-stage study evaluating its immunotherapy Imfinzi (durvalumab) in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer. The phase 3 EMERALD-1 trial has been comparing Imfinzi plus transarterial chemoembolisation (TACE), followed by Imfinzi with or without Genentech’s Avastin (bevacizumab), until progression against TACE alone in more than 600 patients with unresectable HCC eligible for embolisation.