An oral insulin in development at Midatech Pharma (LON:MTPH) has flunked a Phase IIa clinical trial. The dosage form, a dissolving, postage stamp-sized strip designed to deliver insulin through the cheek, failed to achieve bioavailability comparable to subcutaneous administration, leaving the future of the program in doubt.
Abingdon, U.K.-based Midatech had hoped the 12-person trial would show it could deliver insulin by placing a mucoadhesive film on the inside of the cheek. An earlier, 27-person Phase I study suggested the method of delivery could enable faster absorption and utilization of insulin than subcutaneous administration. The data encouraged Midatech and its partner MonoSol Rx to advance the asset into a Phase IIa trial, in which it was put up against Eli Lilly’s ($LLY) subcutaneous insulin Humulin.
The trial failed to produce the release profile Midatech expected to see based on the data generated in earlier studies, resulting in the insulin bioavailability achieved by the transbuccal strip comparing unfavorably to Humulin. “We are obviously disappointed by the results in the insulin MidaSol legacy program,” Midatech CEO Jim Phillips said in a statement. Midatech and MonoSol Rx have now begun “the process of evaluating strategic options” for the faltering program.
Midatech tried to downplay the implications of the setback for the rest of its business, notably by pointing out that the oral insulin is something of an outlier in its pipeline. While the program uses Midatech’s gold nanoparticle (GNP) technology, it also relies on MonoSol Rx’s drug delivery system. In a statement to discuss the Phase IIa failure, Midatech described the combination as a “novel and unique” application of its GNP technology that is not used in the rest of its pipeline.
The argument failed to win over investors, who sent shares in Midatech down more than 15% in the minutes after trading opened in London. Midatech rallied slightly to close down 13%. With a major question mark hanging over the future of the oral insulin program, Midatech sought to talk up the prospects of the rest of its pipeline. For example, MTX110, a treatment for a rare pediatric cancer, is being used on a compassionate basis ahead of a planned clinical trial filing later this year.
- read the statement