Business Wire

NY-VIFOR

Share
Vifor Pharma and Angion report topline results from phase-III registration trial of ANG-3777 in kidney transplant patients at risk for delayed graft function

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211026006150/en/

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN) today announced that the phase-III trial of Angion’s ANG-3777 did not demonstrate a statistically significant difference from placebo on the primary endpoint (eGFR at 12 months) in the population of deceased donor kidney transplant patients who were at risk for developing DGF.

ANG-3777 showed a modest but not statistically significant difference in eGFR of 53.3mL/min/1.73m2 versus 50.4mL/min/1.73m2 for placebo (2.9 mL/min/1.73m2 (p=0.33)). In addition, ANG-3777 demonstrated an inconsistent benefit on key secondary endpoints. Based upon these data, it is not expected there is sufficient evidence to support an indication in the studied DGF population.

The statistical analysis plan also included an analysis of only those people who completed the trial, without using a multiple imputation method to account for missing data and intercurrent events. Under this analysis, ANG-3777 showed a difference on 12 month eGFR of 57.1mL/min/1.73m2 versus 52.2mL/min/1.73m2 (4.9mL/min/1.73m2 , p=0.06) for placebo. These data are potentially indicative of biologic activity of ANG-3777.

The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and consistent with the published literature in this patient population.

“Unfortunately, the results of the phase-III registrational trial did not confirm as strong of an effect as we hoped for in the interests of patients experiencing DGF after kidney transplantation”, said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “These kinds of challenges are part of clinical development activities. Our collaboration with Angion and the development of ANG-3777 in cardiac-surgery associated acute kidney injury (CSA-AKI) continues unchanged, with topline data expected later this year.”

“We are disappointed in the outcome of this trial. While we saw signals of activity for ANG‑3777, we hoped ANG-3777 would robustly demonstrate a benefit for transplant recipients who have no treatment options when their transplants have DGF,” stated Jay Venkatesan, M.D., Angion’s President and CEO. “The totality of the DGF data, together with the CSA-AKI data expected later this year, will inform our clinical strategy with respect to ANG-3777 going forward. I want to extend my special thanks to the patients, their families, and the investigators and their staff members who participated and worked diligently on this trial.”

This multi-center, double-blinded, and placebo-controlled phase-III trial randomized 253 patients 1:1 to receive ANG-3777 or a placebo treatment dosed once per day for three days. Eligible patients received a deceased donor transplant and were determined to be at risk for delayed graft function by having low urine output (oliguria) for more than 8 consecutive hours post-transplant, reflecting potential graft injury. Twenty-five transplant centers in the U.S. enrolled patients in this phase-III registration trial. The primary endpoint was renal function assessed by estimated glomerular filtration rate (eGFR) with a primary analysis time point of eGFR at twelve months using a pre-specified multiple imputation method.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com .

About Angion

Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic. An exploratory Phase 2 trial of ANG-3777 for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is ongoing with data expected in the fourth quarter of 2021. Angion is scheduled to begin a Phase 2 trial evaluating ANG-3070, an oral tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in patients with primary proteinuric kidney diseases. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit www.angion.com .

Angion expects to report cash and cash equivalents as of 30 September 2021 totaling approximately $100 million, when it reports quarterly earnings in November 2021.

About ANG-3777

ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF. An exploratory phase-II trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI) is ongoing with data expected in the fourth quarter of 2021. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications only.

Forward Looking Statements

Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations that release of topline data from the ANG-3777 Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery will be in the fourth quarter of 2021, a global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year, and Angion expects to report cash and cash equivalents as of September 30, 2021 totaling approximately $100 million. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: reporting of trial results or commencing enrollment in clinical trials could be delayed for reasons outside of Angion’s control, including the effects of COVID-19 on Angion’s clinical programs and business operations; and Angion’s September 30, 2021 estimated cash is preliminary and is subject to review and adjustment during the financial review process. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 12, 2021, particularly the information under the caption “Risk Factors,” as well as other documents that may be filed by Angion from time to time with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

GE HealthCare announces CE Mark for the Omni 128cm total body PET/CT system28.11.2025 12:00:00 CET | Press release

FOR USE IN CE-MARK EUROPEAN COUNTRIES ONLY GE HealthCare announces CE Mark for its Omni 128cm total body PET/CT,i a next-generation imaging system designed to advance precision care as well as cancer diagnosis, staging and treatment planning The new system is designed to accommodate head-to-thigh imaging in a single bed to improve workflow and efficiency, and enable a significant reduction in dose/scan time – all important factors, especially for populations like pediatric patients Built for both clinical and research excellence, the system may support the development and evaluation of new clinical pathways, novel PET tracers and emerging theranostic agents GE HealthCare today announced CE Mark for its next-generation Omni 128cm total body positron emission tomography / computed tomography (PET/CT) system,i a major milestone in its mission to advance precision care. Designed to advance cancer diagnosis, staging, therapeutic planning and treatment response monitoring, this innovative sy

King Abdulaziz Foundation Organizes the First Edition of the Forum on the “History of Hajj and the Two Holy Mosques” in Jeddah28.11.2025 10:53:00 CET | Press release

King Abdulaziz Foundation (Darah) held the first edition of the Forum on the “History of Hajj and the Two Holy Mosques”, convened as part of the program of the “Hajj Conference and Exhibition 2025” at the Super Dome Hall in Jeddah, in cooperation with the Ministry of Hajj and Umrah and the Guests of God Service Program, during the period from 9–12 November 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251128600368/en/ King Abdulaziz Foundation Organizes the First Edition of the Forum on the “History of Hajj and the Two Holy Mosques” in Jeddah (Photo: AETOSWire) The forum’s activities were inaugurated following the announcement by His Royal Highness Prince Faisal bin Salman bin Abdulaziz Al Saud, Special Advisor to the Custodian of the Two Holy Mosques and Chairman of the Board of Directors of the King Abdulaziz Foundation, who declared the launch of the forum during the opening ceremony of the “Hajj Conference and Exh

VSO Unveils VCP v1.0, a First-of-Its-Kind Cryptographic Audit Protocol to Restore Trust in AI-Driven Markets28.11.2025 06:30:00 CET | Press release

New open standard replaces opaque server logs with mathematically verifiable evidence, helping market participants meet EU AI Act and MiFID II transparency requirements The VeritasChain Standards Organization (VSO), an independent international standards body, today announced the global release of VeritasChain Protocol (VCP) v1.0, an open cryptographic audit protocol designed to provide mathematically provable transparency for AI‑driven and algorithmic trading systems. VCP replaces mutable server logs with a tamper‑evident chain of cryptographic evidence, enabling regulators, brokers, exchanges and trading firms to move from trust‑based oversight to verification‑based supervision. Why This Matters Now The launch of VCP v1.0 comes at a pivotal moment for global market infrastructure: More than 80 proprietary trading firms collapsed between 2024 and 2025 amid regulatory scrutiny, opaque execution models and frozen payout disputes, leaving a trust gap between traders and platforms. Regula

Andersen Consulting styrker sine kompetencer med BMA27.11.2025 22:48:00 CET | Pressemeddelelse

Andersen Consulting udvider sine kompetencer inden for bæredygtighed og virksomhedsforandring gennem en samarbejdsaftale med BMA, der er et sydafrikansk firma, som arbejder for at styrke konkurrenceevnen i fremstillingsindustrien og fremme inkluderende industriel vækst. BMA, der blev etableret for mere end to årtier siden, arbejder på tværs af produktionsværdikæder – fra producenter til deres kunder – sammen med myndigheder og udviklingsagenturer for at fremme bæredygtig industriel konkurrenceevne. Gennem sine sektorfokuserede industrielle klynger leverer firmaet integrerede tjenester inden for industriel politik og strategisk udvikling, værdikædestrategi, produktionskonkurrenceevne og lean-rådgivning, reduktion af CO2-udledning samt udvikling af små og mellemstore virksomheder og samler interessenter omkring fælles prioriteter og skalerbare, langsigtede løsninger. "Bæredygtig produktion handler om mere end effektivitet. Det drejer sig om at skabe økosystemer, der er regenerative, resi

Stronghold’s SHx Token Lists on Uphold27.11.2025 16:00:00 CET | Press release

Multi-Chain Expansion Accelerates With New Listing on a Trusted Platform Supporting Both Stellar and Ethereum Stronghold announced that its SHx token is now available for retail users to trade on Uphold, the global multi-asset digital money platform known for its transparency, regulatory alignment, and seamless support for assets across both the Stellar and Ethereum networks. The listing marks a major milestone for SHx, expanding access for users and businesses who rely on Stronghold’s token for payments, settlements, and governance participation. "Uphold is one of the only platforms that provides seamless support for both Stellar and Ethereum-based tokens, making it a perfect fit for SHx as we grow our multi-chain ecosystem. This listing was championed by our community, and we’re thrilled to deliver on a request that so many SHx holders have been asking for." — Tammy Camp, CEO & Co-Founder, Stronghold SHx is Stronghold’s native utility token, powering interoperable payments, DeFi-base

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye