MiMedx Group (MDXG) Updates on Program Progress; Says BLA/PMA Compliant Chronic Wound Clinical Trials Near Completion

August 31, 2016 6:23 AM EDT
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MiMedx Group, Inc. (Nasdaq: MDXG) provided an update on the status of key clinical trials.

Plantar Fasciitis Investigational New Drug ("IND") Study Receives FDA Approval for Protocol Amendment Reducing Follow-up Requirements by One Year

Pursuant to the Company's agreement with the Food and Drug Administration ("FDA") to pursue a Biologics License Application ("BLA") with the Company's AmnioFix® Injectable product, MiMedx entered a Phase IIB Randomized Control Trial ("RCT") for the treatment of plantar fasciitis in August, 2014. The FDA approved the clinical study protocol which targets 146 subjects at up to 20 clinical sites. The study has met a very significant milestone. In the initial protocol, a 24-month follow-up blood draw was requested by the Agency in order to determine if the micronized dHACM injection elicited an immune response in patients. An amendment was submitted to the FDA based on generated data requesting a protocol amendment to remove the 24-month follow-up requirement for this clinical trial. Because of the excellent safety profile and the lack of immunogenic response seen in the study patients thus far, the FDA has agreed that two year data is NOT needed and reduced the requirement to one year. This is a major milestone for this study.

Parker H. "Pete" Petit, Chairman and CEO, said, "At present, 109 of the 146 patients have been consented and 103 randomized in the plantar fasciitis study, in a total of 13 sites, and the study should be fully enrolled by the end of the year. In terms of cost, the total expenditure for this study is projected to be slightly over $2 million, a large portion of which has already been expensed since the inception of the study in late 2014."

BLA/PMA Compliant Chronic Wound Clinical Trials Near Completion

Bill Taylor, President and COO, stated, "In anticipation of additional needs for future regulatory and/or reimbursement purposes, we have had two large, multi-center chronic wound studies under way since 2014. One study is for diabetic foot ulcers ("DFUs") and the other is for venous leg ulcers ("VLUs"). These large studies follow the multiple clinical trials with EpiFix® concluded over the years, including the published 100 patient comparative effectiveness trial against a competitive product, and complete the DFU and VLU clinical trials for EpiFix. As with the comparative effectiveness study, the two studies that are underway follow the 2006 FDA Guidance for Industry-Chronic Cutaneous Ulcer and Burn Wounds. This is the guidance document that outlines clinical trial design for Premarket Approval ("PMA") and BLA products."

The multi-center DFU study was designed to have in excess of 10 sites and a target enrollment of 130 patients. This study currently has 12 sites enrolling patients, with 105 enrolled to date. The Company expects to complete enrollment by the end of this year. This study has been ongoing since 2014. The total cost of the study is expected to be less than $2 million, and a large portion of this estimated $2 million has already been expensed by the Company.

The multi-center VLU study targeted in excess of 10 sites and 120 patients. At present, 11 sites have enrolled 123 patients. MiMedx expects that this study will conclude enrollment shortly, and will be completed by the end of this year. This study is also expected to cost under $2 million. As with the other two studies mentioned above, a large portion of the cost of this study has already been expensed.

Investments in Clinical Trials Position MiMedx Favorably for Any Outcome from FDA Industry Meeting

Petit commented, "We expect the industry meetings that the FDA is holding on September 8, 12 and 13, 2016 to be very enlightening and productive relative to questions that have arisen over the last several years on amniotic membrane and other tissue allografts. We will be extending a thank you to the FDA for the approach it is now taking to these two meetings. Including industry, physicians, scientists and patients in the deliberations will be very beneficial. Regardless of how these discussions are perceived, we believe MiMedx is the best positioned organization to fulfill further regulatory requirements in the future, if they are mandated. As a matter of fact, we have already incurred much of the expenses to do so. In addition, we are now past the half way point in patient enrollment for our IND/BLA study for our micronized allograft, and we expect completion of patient enrollment near the end of 2016."

"It is well known that the FDA is reviewing its HCT/p 361 regulations and Draft Guidance documents, and considering potentially further modifications of the regulations. By early 2017, MiMedx will have completed a total of three large multi-center clinical trials for EpiFix on chronic wounds that will meet the FDA's 2006 Guidance Document for Phase III clinical trials of chronic wounds. The FDA typically only requests two such studies in BLA programs, so we are extremely well positioned for any potential changes in regulations related to HCT/ps and their use in chronic wounds. Also, MiMedx has already spent the majority of the dollars needed for those clinical trials. Should the FDA update its regulations such that our EpiFix product line would need a BLA after a suitable transition period, or frankly, if we decide to voluntarily request a BLA for a specific indication for use, we feel that the data we will have from these three large clinical trials should be sufficient to meet the FDA's clinical trials requirement for a BLA. Therefore, we believe that MiMedx is in the leadership position in this area, no matter which direction the FDA takes relative to updating its Draft Guidance documents and regulations," added Taylor.

Petit commented, "In the event that the FDA Draft Guidance Document on Homologous Use is finalized exactly as published in the draft documents, we would disagree that the science supports such a result; however, we will comply with the new regulations. If we don't appeal or otherwise contest the changes, we will simply change our marketing material to match the examples in the Draft Guidance. If that happens, I expect that we will immediately begin to enter the process for a BLA. We expect that the clinical data that we will have from our three Phase III level studies will meet the study requirements for a BLA for chronic wounds. The two remaining studies should be complete and submitted for publication early next year."

Shareholder Call

MiMedx management will host a live broadcast of its conference call to discuss the clinical studies highlighted in this press release. In light of the upcoming Labor Day holiday, the conference call will be held on Wednesday, September 7, 2016, beginning at 10:30 a.m. eastern time. A listen-only simulcast of the MiMedx Group conference call will be available on-line at the Company's website at www.mimedx.com. A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast. The replay can also be found on the Company's website at www.mimedx.com.

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