MyMD plans Phase II trial talks with IQVIA after US FDA nod
MyMD Pharmaceuticals plans to begin talking to IQVIA about a Phase II study of its oral rheumatoid arthritis candidate, MyMD-1.
The Baltimore drug developer made the comments this week after the US Food and Drug Administration (FDA) accepted the investigational New Drug Application (IND) for the drug, which is an oral TNF-α inhibitor.
The firm said the IND application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel (etanercept).
The company added that it plans to initiate discussions with clinical research organization (CRO) vendor IQVIA on timing of a Phase II study.
According to Chris Chapman, president, director, and chief medical officer of MyMD, “FDA acceptance of an IND in RA for our next-generation oral TNF-α inhibitor, MYMD-1, is our most significant milestone as it adds substantial momentum to our clinical program with sufficient funding and targets one of the largest potential market opportunities.
“We are excited to initiate discussions with our CRO regarding a Phase II clinical trial in RA and believe the statistically significant biomarker data from the Phase II study in sarcopenia show MYMD-1 has the potential to disrupt the TNF-α inhibitor market and offer therapeutic benefit to patients with a range of chronic inflammatory conditions.”
“This is significant news and suggests MYMD-1 may hold promise to be the first oral TNF-α inhibitor and a potential future treatment for rheumatoid arthritis,” said clinical researcher, rheumatologist and past President of the Florida Society of Rheumatology, Robert Levin.
He added, “There remains a need for new oral therapies with novel mechanism of action for patients not served by current options and I look forward to leading upcoming Phase II studies of MYMD-1.”
Recently, MyMD announced positive, statistically significant Phase II study results in participants with sarcopenia/frailty which showed MYMD-1 reduced TNF-α, IL-6 and sTNFR1, biomarkers which are common to a number of chronic inflammatory diseases, and met all safety and tolerability endpoints.
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