PhaseBio Pharmaceuticals is close to finishing clinical trials on drug candidates targeting hyperglycemia, pulmonary arterial hypertension and diabetes which all use unique slow-release technology that will allow less frequent administration for patients.
CEO of PhaseBio, Christopher Prior, told In-Pharmatechnologist.com: “We’ve applied the technology to create highly differentiated products in terms of improved efficacy, tolerability, less frequent dosing and ease of delivery.”
The technology is based on heat-sensitive recombinant biopolymers called Elastin-Like Polypeptides (ELPs). At room temperature the polymers are liquid, but when injected under the skin the body temperature turns the ELP and the fused peptide combination into an oily gel.
This gel then slowly releases the therapeutic peptide over an extended period. Studies in mice showed that release was sustained for 120 times longer than if the peptide had been injected on its own.
Prior described it as being a “very pragmatic enabling technology for optimizing peptides” and due to it both the ELP and the peptide being amino acids, it is a technology that does not rely on any other technology and is thus cost-effective and simple to produce.
Peptide drug delivery
Peptide drugs are an effective therapy in type 1 and 2 diabetes, as well as in patients with heart issues but previous technologies have been compromised by low bioavailabilty meaning sufferers have to undertake a frequent series of sometimes painful injections.
Microsphere-release also works by being injected under the skin and slowly releases peptides as it degrades. However it is a far less stable technology than ELP and more expensive to produce due to the complexity of producing the lipid based bi-polymer particles and the threat of the peptide falling apart under the skin in a problem known as the ‘burst effect.’
Philadelphia based PhaseBio has held the license for the ELP technology – developed by Duke University, North Carolina - for over ten years, and now has three drug candidates in the pipeline.
“We, held off from pharma interest in research programs so that we could focus on creating our own high value products,” said Prior. “This is the year that our products are ready for partnering with big pharma.”
Novo Nordisk is already applying the technology in its drug Victoza, but at present it is only offers a one-day version.
The most advanced candidate is PB1023, a treatment for hyperglycemia, which will complete phase IIb clinical trials in the third quarter of 2013. In phase IIa trials PB1023 demonstrated full round the clock glycemic control in patients right up to the next injection administered weekly.
PhaseBio also has an insulin peptide currently in development which Prior told us will attract a lot of interest from Big Pharma companies who are anticipating clinical trial results.
Insulin administration has been an issue as companies look to capitalize on new delivery techniques for the large numbers of type I and II sufferers who rely on it. Attempts by Pfizer and Mankind at delivering insulin by inhaler been less than successful and drug companies are continuing to search for an alternative.
Eli-Lilly has recently invested $140m in its in-house insulin production capabilities in order to meet demand for the drug and thus new delivery technology will be integral to capitalize on the market.