Positive Topline Data Reported from argenx's ADHERE Study of VYVGART® Hytrulo with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Chronic Inflammatory Demyelinating Polyneuropathy
- ADHERE study met its primary endpoint, demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo
- VYVGART Hytrulo showed a 61% reduction in the risk of relapse
- Safety and tolerability profile of VYVGART Hytrulo consistent with its confirmed safety profile
- Successful outcome for VYVGART Hytrulo in CIDP, following recent approval in generalized myasthenia gravis
- None.
ADHERE Data Highlights
- Primary endpoint met (p=0.000039); VYVGART® Hytrulo demonstrated
61% reduction (HR: 0.3995% CI: 0.25; 0.61) in the risk of relapse versus placebo - Safety and tolerability profile consistent with confirmed safety profile of VYVGART®
"We are delighted with the strong data in CIDP and what it can mean for patients living with this challenging condition. Following the recent approval in generalized myasthenia gravis, this is the second successful outcome for VYVGART Hytrulo this year, with two additional study readouts for ITP and pemphigus expected in the fourth quarter," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are pleased that our partnership with argenx continues to support our shared mission to improve the lives of people suffering from severe autoimmune diseases."
About ADHERE Trial Design
The Phase 2 ADHERE trial was a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE enrolled 322 adult patients with CIDP who were treatment naïve (not on active treatment for ≥6 months) or being treated with immunoglobulin therapy or corticosteroids. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to enter Stage A and receive VYVGART Hytrulo, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and they had to demonstrate active disease, with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment naïve patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) to VYVGART Hytrulo. ECI was achieved through improvement of INCAT score, or improvement on I-RODS or mean grip strength if those scales had demonstrated worsening during the run-in period. In Stage B, patients were randomized to either VYVGART Hytrulo or placebo for up to 48 weeks. The primary endpoint was based on the hazard ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an open-label extension study to receive VYVGART Hytrulo.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in six commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceutical, Pfizer and Idorsia Pharmaceuticals.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients and broadening the treatment options for the indication referred to in this press release. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner, potential additional data readouts, indications and eligible patients for the ENHANZE® co-formulated treatment referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether new ENHANZE® collaborative products are ultimately developed, approved or commercialized or whether additional indications for the ENHANZE® co-formulated treatment referred to in this press release will be approved, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
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SOURCE Halozyme Therapeutics, Inc.
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