Algorithm acquires pump for PulmoProst, potential PAH therapy
Treatment aims at precise iloprost delivery via implantable infusion pump
Algorithm Sciences, which is developing PulmoProst to treat pulmonary arterial hypertension (PAH), has acquired all assets of Flownix Medical, including the Prometra II pump that would deliver the potential therapy.
PulmoProst is an infusion formulation of iloprost, a synthetic version of naturally occurring prostacyclin, a substance that induces the widening of blood vessels to lessen resistance to blood flow.
The therapy aims to leverage the Prometra II implantable infusion pump for continuous delivery into the bloodstream. PH treatments in this drug class given by IV infusion are considered more likely to improve patient survival, Algorithm states on a webpage.
In an inhaled formulation, iloprost currently is approved to increase exercise capacity in PAH patients in the U.S. and Europe, available under the brand name Ventavis.
Implantable pump for ‘precision delivery’ of potential PAH treatment
“We believe that the Prometra II implantable pump is the best available technology for precision delivery of life-saving drugs,” Mike Tilton, CEO of Algorithm, said in a company press release
“That was the reason we chose it for our Pulmonary Arterial Hypertension program and that is why we intend to pursue other partnerships in a wide array of indications where consistent, low-maintenance, precision dosing of proprietary medicines can have a meaningful impact on patient quality of life and outcomes,” Tilton added.
PAH is a type of pulmonary hypertension caused by the narrowing of pulmonary arteries, the small blood vessels that transport blood through the lungs. This restricts blood flow across the lungs, leading to high blood pressure and making the heart work harder to pump blood to the body.
Ventavis was seen in clinical trials to help prevent disease progression, but real-world data suggests that inhaled Ventavis is of limited effectiveness for patients’ long-term survival.
Intravenous prostacyclin therapies have shown greater survival benefits with PAH, in addition to easing disease symptoms, Algorithm reports. Continuous intravenous delivery of iloprost to patients also is expected to reduce the oscillations in iloprost levels seen with inhaled and oral therapies, and to lessen a risk of the infections and infusion site reactions observed with repeat IV treatments.
The company now is focused on preclinical studies needed to support an Investigational New Drug (IND) application to begin clinical trials in patients, which it expects to file with regulators shortly.
Algorithm completed a special protocol assessment with the U.S. Food and Drug Administration, allowing it to start a single registrational trial that, once the IND is filed and accepted, could support approval.
Other acquired key assets include intellectual property and premarket approval for the Prometra II pump, together with an existing catalog of pumps and related supplies, Algorithm reported. These help to ensure the company will have ongoing access to the pump and lower overall direct production costs for PulmoProst.
The Prometra II pump, which delivers a continuous, prescribed amount of a medication, has been used to deliver drugs into the spinal canal to treat chronic pain and spasticity, the abnormal muscle tightness due to prolonged muscle contraction. Algorithm intends to continue to sell the pump for these indications.
It also plans to partner with companies developing programs similar to PulmoProst, meaning proprietary treatments administered using a device, for other conditions.
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