This week's Philadelphia-area life sciences news includes updates on Lannett's long-acting insulin drug candidate, Virpax's experimental topical spray film treatment for knee pain and Vesper Medical's latest device.
Here's the roundup:
Lannett Co.
The Bucks County-based generic drug company filed an investigational new drug application with the Food and Drug Administration seeking approval to begin what it said will be the pivotal clinical trial of biosimilar insulin glargine.
Insulin glargine is a long-acting insulin used to treat adults with type 2 diabetes and adults and children with type 1 diabetes.
Biosimilars are designed to be highly similar to an already-approved branded biological product. They are different from generic drugs, which are chemically identical to their branded counterparts. Biological products are more complicated to manufacture in that they are generally derived from a living organism and can come from many sources — including humans, animals, microorganisms or yeast.
Lannett (NYSE: LCI), which is based in Trevose, has operations in Northeast Philadelphia; Seymour, Indiana; and Carmel, New York. It is co-developing its insulin glargine product — a biosimilar to Sanofi-Aventis biotech therapy's Lantus — with the HEC Group of companies based in China.
Tim Crew, CEO of Lannett, called the submission a key milestone for the company. "[It] brings us one step closer to bringing this critically important and more affordable biosimilar medicine to the large and growing number of patients living with diabetes," he said.
Crew said Lannett remains on track to begin the clinical trial in or around March 2022. If the study is successful, Lannett would be in position to file a biologics license application seeking approval for the product in early 2023 — and potentially launching the product by early 2024, he said.
Virpax Pharmaceuticals
The Berwyn developer of pain management medicines signed a clinical trial agreement with clinical trial services company Altasciences Co. Inc. that will conduct a first-in-human study of Virpax's (NASDAQ: VRPX) new drug candidate Epoladerm for pain associated with osteoarthritis of the knee.
Financial terms of the deal are being kept confidential
The study will take place in Canada. Patient enrollment is expected to begin by the second quarter of 2022.
Epoladerm is an analgesic that the company designed to be supplied in a pre-filled aerosol canister for administration as a topical spray film to help patients manage chronic pain associated with knee osteoarthritis. The film, according to Virpax Founder and CEO Anthony Mack, is thinner than a standard liquid bandage, is visibly clear on the knee and is fast-drying. The spray formulation is being developed as an alternative to the "inconvenient and messy application" of creams or gels on the knee.
Vesper Medical
The Wayne-based medical devices developer completed patient enrollment for its late-stage study of the Vesper Duo Venous Stent System in patients with chronic venous Insufficiency.
The condition is characterized by improper functioning of the vein valves in the leg, which causes swelling and skin changes. Symptoms of the condition include varicose veins, swelling, or skin color changes on the affected leg. If the condition progresses, leg ulcers can form.
The Vesper Duo Stent System is "uniquely engineered" to address the challenges of deep vein obstruction, according to the company.
Vesper said it enrolled its 160th patient in the pivotal study ahead of schedule earlier this month.
Quick hits
Philadelphia-based Vallon Pharmaceuticals (NASDAQ: VLON) said the last patient has completed their final visit in the company's pivotal intranasal abuse study evaluating its new drug candidate Adair. Adair is a proprietary abuse-deterrent formulation of immediate-release dextroamphetamine designed to treat attention deficit hyperactivity disorder and narcolepsy. Vallon expects to report results from the study during the first quarter of 2022.
