Titan Pharmaceuticals (NSDQ:TTNP) this month revealed a collaboration with the Walter Reed Army Institute of Research to evaluate the use of its ProNeura drug-delivery technology for the long-term prevention of malaria.
The company is already working to develop its implant for an array of applications. Titan president & CEO Sunil Bhonsle told Drug Delivery Business News that this partnership was crucial to extend its reach into malaria.
“They have the expertise that we don’t have internally so this is, for us, very important,” he said.
Bhonsle added that Titan has conducted internal assessments to identify other arenas for which the ProNeura technology could be applicable, but that this marks the first time an external partner is interested in collaborating and moving a product through clinical development.
Preclinical testing conducted by Walter Reed and the Southwest Research Institute demonstrated that ProNeura implants containing an antimalarial compound, piperaquine, yielded sustained drug release for 6 weeks and sufficiently suppressed malaria in infected mice. The group also reported that the implants protected mice against infection from malaria-causing parasites for up to 8 weeks post-implantation.
They also assessed other antimalarial drugs, including atovaquone and doxycycline, for use with the ProNeura implants.
“This initial study showed that indeed you can maintain a sustained delivery,” Bhonsle told us. “Then you challenge the animal model with the parasite and see if there is prevention – and they were able to establish that.”
“They have indicated that through their different groups in several countries outside of the US, they have access to testing this clinically and would very much be amiable to doing that if we can find the right drug and product that they feel comfortable with,” he added.
Besides its latest foray into malaria prevention, Titan is leveraging it’s ProNeura drug delivery technology for a variety of uses, including the treatment of Parkinson’s disease and opioid addiction.
Earlier this year, the FDA asked Titan for more information relating to its ropinirole implant for Parkinson’s disease before deciding if it would approve the company’s investigational new drug application. The regulatory agency asked for final release test data on its ropinirole implant and the applicator used to insert the implant.
Bhonsle said it has done that and if all goes well, the company expects to begin its Phase I/II trial this quarter.
“And that will be an important event for us,” he said, stressing that the ropinirole trial is the company’s priority.
But he also added that based on resources, they could bring their T3 hypothyroidism implant into clinical trials by late next year.
“We’re still a small company and everything relies on funding,” he said.
The Probuphine 6-month buprenorphine implant for the maintenance treatment of opioid addiction is Titan’s first ProNeura-based product to get to market. Titan touts the device as the first marketed product to provide maintenance treatment continuously for 6 months following a single administration procedure.
The product was commercialized through Titan’s partner, Braeburn Pharmaceuticals. Braeburn began selling Probuphine at the start of the first quarter this year, according to Bhonsle, and has since built an internal sales force of 60 employees.
“Some of the early patients that were treated last year have completed their six months and have come back for re-treatment for a second six months,” Bhonsle said. “So, there’s been good success initially.”
He added that Titan does not yet have a partner in Europe to help bring Probuphine to market, but the company is on the look-out. The team is slated to meet with European regulatory authorities this summer to review what they will need for the marketing authorization application.
“So, that process is moving along as expected and we are on track to file the MAA in the fourth quarter of this year,” Bhonsle said. “And our goal is to have a partner lined up there.”