Unigene Laboratories, Inc., a leader in the design, delivery, manufacture and development of peptide-based therapeutics, and Tarix Pharmaceuticals, a clinical stage biopharmaceutical company developing peptide drugs, have successfully completed a feasibility study of an oral formulation of TXA127, Tarix’s lead peptide drug candidate.  

Data from the feasibility study demonstrated that the oral formulation of TXA127 produced extremely high exposure in the blood that resulted in a several-fold increase in bioavailability as compared to the oral delivery of the unformulated drug, and was equal to or greater than that achieved by the current subcutaneous formulation.

The oral formulation, developed jointly by Unigene and Tarix under a previously agreed upon feasibility program, leverages Unigene’s Peptelligence™ technology platform to enable enhanced oral delivery of TXA127. Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation, reduction in GVHD and mucositis following allogeneic stem cell transplantation, and peripheral vascular disease. In September 2011, TXA127 was granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH), a rare disease resulting from insufficient cardiac output.  Unigene’s Peptelligence platform comprises peptide oral drug delivery and manufacturing assets, expertise and capabilities.

Ashleigh Palmer, Unigene’s chief executive officer, commented, “The results of the TXA127 feasibility study exceeded our expectations and clearly indicate that Unigene’s Peptelligence™ platform is the gold-standard for developing orally administered peptides.  Not only did the oral formulation of TXA127 deliver the drug successfully, data from the study showed that it produced a highly significant increase in bioavailability. We greatly look forward to extending our relationship with Tarix and its development of the oral formulation of TXA127, as well as advancing the 13 additional feasibility programs evaluating our Peptelligence platform.”

Rick Franklin, M.D., Ph.D., chief executive officer of Tarix, commented, “The ability to deliver TXA127 orally, and do so in a manner that improves the performance of the drug, significantly enhances its therapeutic potential for the multiple conditions we are pursuing, while also serving to increase its overall value and marketability. We couldn’t be more excited by the results of the feasibility study and the performance of Unigene’s Peptelligence technology. We look forward to applying Unigene’s technology to our other peptides.”

According to the terms of the feasibility programme, Tarix will have an exclusive worldwide license to Unigene’s technology covering the use of that technology with Angiotensin (1-7), the pharmaceutical ingredient in TXA127, as well as its functional equivalents, analogues or derivatives.  In return for the license, Tarix will pay Unigene a percentage of revenues derived from the direct sales of the product by Tarix or from up-front, milestone or royalties received by Tarix from a third-party sublicensee.

TXA127 is a pharmaceutical formulation of the naturally occurring peptide, Angiotensin (1-7).  Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation, acute respiratory distress syndrome (ARDS), and pulmonary arterial hypertension (PAH). TXA127 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) as a treatment for pulmonary arterial hypertension, to enhance engraftment in patients receiving a stem cell transplant, and for Myelodysplastic Syndrome (MDS). Tarix is developing a related peptide, PanCyte, for stroke and diabetes.