Empagliflozin

Results from MUSIC-HFpEF Phase 1/2a clinical trial show favorable safety profile and early clinical benefits with SRD-002 gene therapy BOSTON, May 19, 2025 (GLOBE NEWSWIRE) -- Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing a range of next-generation therapeutics, today announced that positive interim data from its ongoing MUSIC-HFpEF Phase 1/2a clinical trial was presented at the Heart Failure 2025 Congress taking place in Belgrade, Serbia. The late-breaking presentation, titled "Gene therapy for heart failure with preserved ejection fraction," was delivered by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Center, during the "Late-Breaking Clinical Trials in Chronic Heart Failure" session. The MUSIC-HFpEF trial is investigating SRD-002, a one-time gene therapy treatment for heart failure with preserved ejection fraction (HFpEF) delivered through a proprietary minimally invasive intracoronary infusion methodology. SRD-002 utilizes an adeno-associated type 1 virus vector carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase pump (SERCA2a) to directly target the molecular pathways underlying the core pathology of HFpEF by enhancing myocardial relaxation and reducing stiffness. The trial is evaluating the therapy in HFpEF patients with exercise-induced diastolic dysfunction, including those with LVEF ≥ 50% and symptomatic HFpEF defined by prior hospitalization or New York Heart Association (NYHA) Class II or III symptoms. The presentation highlighted interim data from the ongoing trial, which, as of the data cutoff date, has treated five patients in Cohort A with a low dose of 3x1013 viral genomes (vg) per patient and one patient in Cohort B at a dose of 4.5x1013 vg per patient. With follow-up ranging from 4 to 16 months, no gene therapy-related serious adverse events have been reported. Four out of five patients in the low-dose group have shown improvements in NYHA heart failure classification at 6 months, with clinically meaningful improvements in 6-minute walk test (6MWT), decreases/stabilization in NT-Pro-BNP, and high-sensitivity troponin observed in some patients. The enrollment of patients at the higher dose of 4.5x1013 vg per patient is ongoing. “HFpEF represents a significant unmet medical need, affecting approximately half of all heart failure patients worldwide with limited disease-modifying therapeutic options,” said Marat Fudim, MD, MHS. “These early results are encouraging and suggest that SRD-002 may offer a potentially transformative approach for patients with HFpEF by directly addressing the underlying pathophysiology of impaired myocardial relaxation.” “With our therapeutic dosages optimized by our bioengineered human mini-heart HFpEF models – approximately 100-fold less than that of IV infusion – we are pleased with the safety profile and early clinical signals observed in the MUSIC-HFpEF trial to date,” said Ronald Li, Ph.D., CEO and co-founder of Medera. “This first-in-human gene therapy approach represents an important step forward in our mission to develop innovative therapies for cardiovascular diseases with limited treatment options.” The Heart Failure Congress is the world's leading event covering the entire spectrum of heart failure, from prevention to diagnosis and treatment. It is the annual meeting of the Heart Failure Association of the European Society of Cardiology. For additional information about the MUSIC-HFpEF trial, visit ClinicalTrials.gov using the study identifier NCT06061549. On September 5, 2024, Medera and Keen Vision Acquisition Corporation ("KVAC") (NASDAQ:KVAC, KVACW), announced they had entered into a definitive merger agreement. About Heart Failure with Preserved Ejection Fraction (HFpEF) Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide and a rising prevalence trend. Accounting for 50% or more of the overall HF population, HFpEF is an age-related condition that has become increasingly prevalent in recent years. This surge is partly due to better awareness and identification of the condition and partly due to lifestyle changes affecting cardiac myocytes. Individuals affected by HFpEF experience similar morbidity and mortality to patients with HF with reduced ejection fraction (HFrEF). Despite the growing epidemic of this emerging syndrome, HFpEF-focused interventional trials have had little success, except for the use of sacubitril-valsartan (Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance™) for reducing cardiovascular mortality and heart failure hospitalization. However, these agents are not disease-modifying, highlighting the critical need for therapeutic interventions targeting the physiological mechanisms involved in HFpEF. About Medera Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively. Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials. Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases. For more information, please visit www.medera.bio. About Keen Vision Acquisition Corporation Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives. For more information, please visit www.kv-ac.com. Forward-Looking Statements Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward-looking statements. In some cases, you can identify forward-looking statements by words such as "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "strategy," "future," "opportunity," "may," "target," "should," "will," "would," "will be," "will continue," "will likely result," "preliminary," or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements include, without limitation, KVAC's, Medera's, or their respective management teams' expectations concerning the outlook for their or Medera's business, productivity, plans, and goals for future operational improvements and capital investments, operational performance, future market conditions, or economic performance and developments in the capital and credit markets and expected future financial performance, including expected net proceeds, expected additional funding, the percentage of redemptions of KVAC's public shareholders, growth prospects and outlook of Medera' operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Medera's projects, as well as any information concerning possible or assumed future results of operations of Medera. Forward-looking statements also include statements regarding the expected benefits of the transactions contemplated by the merger ("Transaction"). The forward-looking statements are based on the current expectations of the respective management teams of Medera and KVAC, as applicable, and are inherently subject to uncertainties and changes in circumstance and their potential effects. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of KVAC's securities; (ii) the risk that the Transaction may not be completed by KVAC's business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by KVAC; (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the adoption of the Merger Agreement by the shareholders of KVAC and the receipt of certain regulatory approvals; (iv) market risks; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the effect of the announcement or pendency of the Transaction on Medera's business relationships, performance, and business generally; (vii) the outcome of any legal proceedings that may be instituted against Medera or KVAC related to the Merger Agreement or the Transaction; (viii) failure to realize the anticipated benefits of the Transaction; (ix) the inability to maintain the listing of KVAC's securities or to meet listing requirements and maintain the listing of Medera's securities on Nasdaq; (x) the inability to implement business plans, forecasts, and other expectations after the completion of the Transaction, identify and realize additional opportunities, and manage its growth and expanding operations; (xi) risks related to Medera's ability to develop, license or acquire new therapeutics; (xii) the risk that Medera will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xiii) the risk of product liability or regulatory lawsuits or proceedings relating to Medera's business; (xiv) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xv) risks related to regulatory review, and approval and commercial development; (xvi) risks associated with intellectual property protection; (xvii) Medera's limited operating history and risk that it may never successfully commercialise its products; (xviii) Medera expects to continue to incur significant losses and may never achieve or maintain profitability; and (xix) the risk that additional financing in connection with the Transaction may not be raised on favorable terms. The foregoing list is not exhaustive, and there may be additional risks that neither KVAC nor Medera presently knows or that KVAC and Medera currently believe are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the "Risk Factors" section of KVAC's Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 29, 2024, the risks to be described in the registration statement, which will include a preliminary proxy statement/prospectus, and those discussed and identified in filings made with the SEC by KVAC from time to time. Medera and KVAC caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth in this press release speak only as of the date of this press release. Neither Medera nor KVAC undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Medera or KVAC will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the Transaction, in KVAC's public filings with the SEC, and which you are advised to review carefully. Important Information for Investors and Shareholders In connection with the Transaction, KVAC and Medera filed a registration statement with the SEC, which includes a prospectus with respect to the securities to be issued in connection with the Transaction and a proxy statement to be distributed to holders of KVAC's ordinary shares in connection with KVAC's solicitation of proxies for the vote by KVAC's shareholders with respect to the Transaction and other matters to be described in the Registration Statement (the "Proxy Statement"). After the SEC declares the registration statement effective, KVAC plans to mail copies to shareholders of KVAC as of a record date to be established for voting on the Transaction. This press release does not contain all the information that should be considered concerning the Transaction and is not a substitute for the registration statement, Proxy Statement or for any other document that KVAC may file with the SEC. Before making any investment or voting decision, investors and security holders of KVAC are urged to read the registration statement and the Proxy Statement, and any amendments or supplements thereto, as well as all other relevant materials filed or that will be filed with the SEC in connection with the Transaction as they become available because they will contain important information about, Medera, KVAC and the Transaction. Investors and security holders will be able to obtain free copies of the registration statement, the Proxy Statement and all other relevant documents filed or that will be filed with the SEC by KVAC through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by KVAC may be obtained free of charge from KVAC's website at https://www.kv-ac.com or by directing a request to info@kv-ac.com. The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release. Participants in the Solicitation KVAC, Medera and their respective directors, executive officers and other members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitations of proxies in connection with the Transaction. For more information about the names, affiliations and interests of KVAC's directors and executive officers, please refer to KVAC's annual report on Form 10-K filed with the SEC on March 29, 2024, which can be found at https://www.sec.gov/ix?doc=/Archives/edgar/data/1889983/000121390024027973/ea0201104-10k_keenvision.htm and registration statement, Proxy Statement and other relevant materials filed with the SEC in connection with the Transaction when they become available. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, which may, in some cases, be different than those of KVAC's shareholders generally, will be included in the registration statement and the Proxy Statement and other relevant materials when they are filed with the SEC when they become available. Shareholders, potential investors and other interested persons should read the registration statement and the Proxy Statement and other such documents carefully, when they become available, before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in the Transaction shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Contacts:Keen Vision Acquisition CorporationAlex DavidkhanianChief Financial OfficerEmail: alex.davidkhanian@kv-ac.com MederaInvestor RelationsStephanie CarringtonICR HealthcareStephanie.Carrington@icrhealthcare.com(646) 277-1282 Media RelationsSean LeousICR HealthcareSean.Leous@icrhealthcare.com(646) 866-4012

New Delhi: As domestic brands in India began introducing their generic versions of key anti-diabetic medicine empagliflozin following the expiry of its patent, the National Pharmaceutical Pricing Authority (NPPA), has fixed the retail prices of the drug combinations and different dosage strengths. Issuing a gazette notification, the Ministry of Chemicals and Fertilizers and the country’s drug price regulator announced that “based on the decision of 132nd Authority meeting dated 29.4.2025 the authority has fixed retail prices of 84 formulations under Drugs (Prices Control) Order, 2013.” The price list attached with the official notification includes around 36 variants of empagliflozin, linagliptin and metformin hydrochloride Fixed-Dose Combinations (FDC) of various brands and manufacturers. Empagliflozin, indicated for Type-2 diabetes, inhibits the release of SGLT2 protein in the kidneys which reduces glucose reabsorption in blood and helps in lowering the blood sugar level of patients. Under the notified list the combination of empagliflozin 12.5mg and metformin hydrochloride 1000mg tablet of Corona Remedies is priced at ₹19.64, while a combination including linagliptin along with these active ingredients of Lupin is priced at ₹22.32. The notified retail prices excludes the applicable Goods and Services Tax (GST) and are applicable to the respective manufacturer and marketer specified in the list. As per a market research firm Pharmarack as of April 2025 the total market of empagliflozin and its related combination is valued around ₹745 crore. Of this, plain empagliflozin and its combination with linagliptin accounts for nearly 86 per cent of the total market. In FY25 empagliflozin plain tablets reported a Moving Annual Turnover of ₹337 crore, reflecting a market share of 45 per cent while its combination version with linagliptin had a MAT value of ₹308 crore and a market share of 41 per cent. Besides this the drug's other combinations such as empagliflozin and metformin reported an annual turnover of ₹102 crore with a 14 per cent market share. The retail price fixation exercise has been undertaken in the aftermath of the expiry of empagliflozin’s patent in March this year followed by a series of generic entrants in the market. In India, the drug patent was owned by Germany-based Boehringer Ingelheim and the drug was marketed under the brand name Jardiance. After the drug went off patent, companies like Alkem and Glenmark launched their generic versions under the brand names ‘Empanorm’ and ‘Glempa’ respectively. Besides them other major generic players like Mankind and USV also joined the fray. For patients, the development gave a major price relief as the generic versions are stated to cost around 80-90 per cent less than the patented version. As per the NPPA price list the innovator's version single tablet is priced at ₹53, whereas the other brands from the license holders Torrent, Cipla and Lupin are priced between ₹46-48 per tablet. While announcing the launch, Rajeev Juneja, Vice Chairman and Managing Director, Mankind Pharma said that, “the company will market its respective brand at ₹5.49 per tablet for the 10 mg variant and ₹9.90 per tablet for the 25 mg variant. The latest monthly progress report of Indian pharma market by Pharmarack suggests that as of April close to 147 brands from 37 companies have forayed in the empagliflozin plain and combinations market, reflecting a two-fold jump from the previous month status of 86 brands and 19 Companies. Under the provisions of Drugs (Prices Control) Order, 2013, the retail price of a new drug is fixed by NPPA and the applicant manufacturer and marketer, are required to sell the new drug within the notified price. By Abhijeet Singh ,