Skin patch successfully delivers PAH treatment in early clinical trial
Patch designed to deliver treprostinil works as intended in healthy volunteers
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Corsair Pharma‘s experimental skin-worn patch designed to deliver treprostinil, an approved treatment for pulmonary arterial hypertension (PAH), appears to be working as intended, according to newly announced data from an early clinical trial in healthy volunteers.
“These data support the potential of our transdermal [through-the-skin] platform as a clinically meaningful alternative to existing treprostinil delivery modalities,” Bobby Singh, PhD, president and chief operating officer of Corsair, said in a company press release.
PAH is marked by abnormally high pressure in the vessels that carry blood from the heart through the lungs. Treprostinil is a lab-made version of prostacyclin, a naturally occurring hormone that reduces blood pressure by prompting blood vessels to relax and dilate (widen).
Several versions of treprostinil are approved for PAH. The first versions of the drug, sold as Remodulin and its generics, are given by injection under the skin or infusion into the bloodstream. More recent formulations are administered as extended-release oral tablets (sold as Orenitram) or an inhaled solution (available as Tyvaso) that is also approved to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).
All these available formulations are sold by United Therapeutics, which has been collaborating with Corsair on the development of the skin patch. An additional inhaled formulation of treprostinil for PAH and PH-ILD is sold by Liquidia, and is called Yutrepia.
Patch aims to overcome ‘challenges’ of existing delivery systems
Corsair’s TRX-248 transdermal system uses a patch applied to the skin to deliver an inactive prodrug (precursor molecule) called TRX-248 through the skin and into the bloodstream. Once inside the body, TRX-248 is converted into active treprostinil in the liver.
Corsair is developing the system as a more convenient alternative to other treprostinil formulations. “Each current delivery system for treprostinil has significant challenges for patients,” said George Mahaffey, the company’s CEO.
Building on positive preclinical data, Corsair conducted a Phase 1 trial in which nine female volunteers received a single patch application designed for 24-hour wear. The company said results showed the patch delivered steady treprostinil levels into the body, with minimal fluctuation in drug levels over the course of 24 hours. Corsair also said that pharmacological data were broadly consistent with the known profile of injection treprostinil, and that the patch showed an acceptable safety profile.
“We are excited by these first-in-human results demonstrating steady, therapeutically meaningful treprostinil levels using our proprietary prodrug and transdermal technology,” Singh said.
Mahaffey said the “exciting” Phase 1 results “reinforce our prior preclinical findings … [and] provide further evidence that the Corsair Transdermal System may improve the lives of PAH patients.”
