Amryt can’t catch a break. The U.K. biotech’s shares were sent into the red Monday as the FDA returned a complete response letter for the rare skin disease therapy Oleogel-S10.
The agency said the application could not be completed as filed, Amryt said in a release. The company had submitted the gel treatment Oleogel-S10 for dystrophic and junctional epidermolysis bullosa, or EB, which are rare disorders that cause the skin to become fragile and blister from minor friction or trauma.
Amryt will need to provide additional data to show the drug works. The biotech will discuss exactly what is needed with the FDA to resolve the concerns.
This is the latest in the saga of Oleogel-S10, which is stalled before EU regulators who have been unable to come to a decision. In January, Amryt said the decision date was extended into the spring. The European Medicines Agency decision was originally expected in the fall, then moved to January, which was extended once more in the latest update.
Shares were down 20% to $6.48 as of 10:36 a.m. ET on Monday. Amryt was trading around the $10 mark before announcing the EMA delay in January.
“We are extremely disappointed by this decision and we remain committed to our goal of bringing Oleogel-S10 to patients,” Amryt CEO Joe Wiley said.
Wiley touted the company’s clinical trial for EB as the largest randomized study ever conducted in this disease. He said the condition does not have any approved treatments. The Ease study linked Oleogel-S10 to improvements in time to first target wound closure. The study suffered from delays as well, taking longer than expected to get started and dragging on past its planned timeline.
Similar to the EU regulators’ move, the FDA pushed back the decision date for Oleogel-S10, which was originally due at the end of November 2021. The therapy was being reviewed on the agency’s priority review track.
Oleogel-S10 has also been tested for burns, rashes caused by radiation treatment for breast cancer, skin graft wounds and the sun-exposure caused condition actinic keratoses, according to the FDA’s clinical trials database. The radiation indication is listed for a phase 1 study on the company’s website.
Amryt has three approved treatments: Juxtapid/Lojuxta as a supplement to a low-fat diet for patients with the metabolic disorder homozygous familial hypercholesterolaemia; Myalept/Myalepta for complications of leptin deficiency in patients with lipodystrophy; and Mycapssa for certain patients with acromegaly.