Lipella Pharmaceuticals Inc (NASDAQ: LIPO) soared on Thursday after revealing that the FDA had approved its oral disease therapeutic for usage outside of clinical trials.
The biotech company has created a rinse treatment for oral lichen planus — a nasty condition that causes painful sores in a person’s mouth. There are roughly six million people in the U.S. who suffer from the disease. Other symptoms include depression, weight loss and secondary fungal or yeast infections.
Currently, there are no FDA-approved treatment options for this condition. The agency’s decision to give Lipella the green light for an Expanded Access Program will help provide additional data and potentially lead to full FDA approval later down the road. Lipella published a paper about the promising new drug in the Cureus Journal of Medical Science last month.
Medicines that are currently prescribed for oral lichen planus, such as topical steroids and immunosuppressive drugs, are not FDA-approved. The FDA actually warns that immunosuppressive therapeutics often prescribed to patients have an unclear link with cancer, according to the Mayo Clinic.
“We are pleased to make ‘LP-310’ available to patients beyond our Phase 2a clinical trial,” Chief Medical Officer, Michael Chancellor, said in a news release. “With no approved therapies currently available, this approval strengthens our commitment to advancing LP-310 as a potential solution for patients living with this painful and often debilitating condition.”
Lipella focuses on more serious oral condition
This isn’t the only mouth disease that Lipella is developing treatments for. The company has another oral rinse therapeutic used for oral graft-versus-host disease — a condition that also causes painful sores, and chronic dry mouth. People with this affliction have a higher risk of contracting mouth cancer and getting cavities.
This treatment has received orphan drug designation from the FDA. Furthermore, Lipella has obtained investigational new drug approval for an upcoming Phase 2b study on it, expected to commence by the end of June.
Unlike oral lichen planus, it can potentially be fatal.
Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus$LIPO enemy for short sellers if you get in early.
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Bladder disease caused by cancer treatment is Lipella’s other focus
The FDA has given the company’s LP-10 hemorrhagic cystitis treatment orphan drug designation as well.
Those with bladder, prostate or cervical cancer who have undergone chemotherapy or radiation therapy are susceptible to this ailment.
This serious and potentially fatal condition causes various infections, painful urination and other discomforts. About 60,000 people are impacted by it every year.
Lipella says currently available therapies such as steroids and vitamin E are ineffective. Early-stage studies on LP-10 have yielded promising results.
Lipella currently has a cash balance of US$1.3 million and only US$70,800 in debt. Recent R&D costs have been significant, which is typical for a company like this, but Lipella still has a relatively healthy-looking balance sheet.
rowan@mugglehead.com
