We are dedicated to supporting those impacted by frequent and severe hypoglycemia related to hyperinsulinism.

As we advance RZ358 through clinical studies, we regularly interact with patient advocacy organizations around the world to support research and disease awareness. Our interaction with the community is a frequent reminder of the serious unmet patient need and the importance of developing therapies such as RZ358.

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Ersodetug is an investigational drug candidate.  The FDA has not determined that ersodetug is safe or effective.  No indication(s), warnings, precautions, adverse reactions, dosage or administration information for ersodetug have been approved by the FDA.  This video depicts the favorable results of ersodetug use for a single patient.  It is not intended to guarantee or promote that ersodetug will provide similar results for other subjects participating in the ersodetug Phase III clinical trial or Expanded Access Program. 

This video, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “prove,” “potential,” “seek,” “strive,” “try,” or future or conditional verbs such as “predict,” “could,” “may,” “likely,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Viewers are cautioned not to place undue reliance on these forward-looking statements, which speak only as an individual patient. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website at www.sec.gov.

You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. This video shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

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Davelyn-Hood

As the Head of Medical and Patient Affairs, Dr. Davelyn Eaves Hood brings a unique perspective to understanding the needs of patients, caregivers and medical professionals. As a physician as well as the mother of a child who was born with cHI, Davelyn has an understanding of the challenges, frustration and emotional strain of managing a difficult and life-threatening disease. Davelyn has dedicated her career to improving the lives of patients and their families and she spent nine years as President of the Board of Directors for the patient advocacy group, Congenital Hyperinsulinism International. Davelyn was also the Principal Investigator of the Congenital Hyperinsulinism International HI Global Registry, a patient-driven natural history registry, where she worked alongside key HI community stakeholders of advocates, patients and clinicians to design and launch the program. Underpinning the breadth of experience she brings to her role, she is a board-certified family physician and has worked in a variety of practice, healthcare administration and payer settings.

Compassionate Use / Expanded Access / Early Access 

Compassionate Use, also referred to as an Expanded Access, Early Access Program or just EAP, is designed to make an investigational medical product available as early as possible to patients without therapeutic options. This happens when all potential ways to treat a condition have been exhausted or when patients are neither good candidates for approved therapies nor qualify for a clinical trial. EAPs enable these patients to access potentially helpful therapies that are still under investigation and not yet approved for their condition. Rezolute is committed to providing safe and effective therapies for patients and supports the need for EAPs.

Through our EAP, we aim to provide RZ358 to patients who have experienced its therapeutic benefit in our clinical studies and wish to continue their treatment post-trial. The EAP may also be available for those with serious or life-threatening conditions associated with elevated insulin levels causing frequent low blood sugar levels, that lack other therapeutic options.

If you have questions about participating in our clinical trials or feel you may qualify for the RZ358 EAP, please discuss with your healthcare provider, or contact us at: patient-relations@rezolutebio.com

Patient Organizations

The organizations below—all founded by parents of children with cHI—help connect patients and families living with cHI to education, research, clinical care, support services, and the broader cHI community. These are just a few of the organizations with whom Rezolute collaborates to inform our daily work.

Connect With Us

Whether you have been diagnosed with a condition that leads to frequent hypoglycemia due to elevated insulin levels or you are a representative of a patient advocacy organization for these conditions, we look forward to connecting with you about our RZ358 program.

patient-relations@rezolutebio.com.