SinuSys has partnered with Pressure BioSciences to improve the delivery of steroids to the sinuses of patients recovering from surgical treatment of chronic sinusitis. The collaborators will use PBI’s nano-emulsification platform to optimize steroid delivery and minimize the risk of overdose.
Chronic sinusitis patients treated surgically receive spacers or stents that deliver steroids to reduce inflammation, scarring and adhesions. SinuSys has identified perceived shortcomings with existing products, such as uneven degradation that causes inflammation and follow-up surgical procedures, leading it to develop Restora.
The mid-phase experimental product is a spacer designed to provide mechanical support for tissues that are healing after surgery and support the recovery process by eluting the anti-inflammatory steroid mometasone furoate. SinuSys has identified PBI’s Ultra Shear Technology (UST) as a way to improve Restora.
“We believe that PBI's patented UST platform for the preparation of nanoemulsions is a compelling transformational technology for therapeutics. Its use is expected to require loading less of the active steroid into the Restora device, while optimizing controlled dosing delivery with minimized risk of overdose exposure to the patient,” SinuSys CEO Thomas Schreck said in a statement.
The partners will now evaluate the feasibility of using UST to improve the effectiveness of Restora. If the feasibility assessment is a success, SinuSys plans to license the platform for use in the spacer “on its continued path to FDA approval in a phase 2b clinical study later in 2021.” Schreck said he expects UST to enhance the probability of a successful phase 2b trial.
Alexander Lazarev, Ph.D., chief scientific officer at PBI, provided further details of the rationale for applying UST to Restora. Lazarev said formulating hydrophobic active ingredients into nano-emulsions made up of droplets of less than 100 nanometers increases absorption and bioavailability, lowers doses and improves controlled release. Lazarev expects the benefits to translate into lower product costs.