I want to share with you additional information as a follow-up to our announcement on Wednesday, January 6thabout the Newborn X-Linked Hypohidrotic Ectodermal Dysplasias (XLHED) Clinical Trial.

As I stated in the first announcement, Edimer Pharmaceuticals will not enroll any new patients into the current XLHED Newborn Clinical Trial of EDI200. They are also not planning to start any new clinical trials with EDI200 in patients with XLHED at this time. However, they did receive funding from the FDA to look at long-term data which includes dentition. The results on tooth formation, which continues after birth, are only now beginning to be evaluated. They will also continue to work with experts to explore options for earlier dosing.

Prof. Holm Schneider from Erlangen, Germany was one of the initial primary investigators in the clinical trials and continues to work closely with Edimer. He plans to continue the dosing of EDI200 by injecting it into the mother’s amniotic fluid, prior to birth.  This is anticipated to lead to better results. There is a strong feeling that dosing after birth is too late to impact the development of sweat glands and other key markers. This will not be a clinical trial but a “Trial to Cure” which is a legal possibility under the German law.

Prof. Schneider is therefore looking for a participant who needs to be less than 20 weeks gestation. According to the European Union (EU) “Cross Border Health Care Directive,” patients from all EU countries are able to obtain treatment in any EU country if the special treatment does not exist in their home country.  Therefore, the “Trial to Cure” will only be possible in Erlangen, Germany for EU residents.

This could potentially, be the very last chance to prove that EDI200 has an important impact on the development of sweat glands and other structural development of XLHED. Our friends at Edimer apologize that due to legal restrictions, Prof. Schneider’s trial is only possible for European patients.

Unfortunately, this is not available to families in the United States.

If you are a family in the EU, are expecting and may be interested in taking part in the “Trial to Cure” research project, please contact me at 618-566-2020 or email me.

Please share this information with anyone you know who is in the EU, affected by XLHED and is expecting.

Again, we continue to explore all opportunities that can advance research that may lead to better treatments for our families. We shall persevere! Together we will be successful. Thank you, in advance, for your support to help us do just that.

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