Starton Therapeutics advances transdermal lenalidomide STAR-LLD program following successful skin permeation studies

Starton Therapeutics Inc said it has developed several formulations to successfully deliver lenalidomide across the skin. 

With this milestone, the company said it has advanced multiple formulation candidates in its transdermal lenalidomide (STAR-LLD) program into nonclinical studies. 

STAR-LLD is a proprietary, medicated, adhesive patch placed on the skin to deliver lenalidomide continuously at the optimal dose using up to 90% less drug when compared to approved oral formulations.

READ: Starton Therapeutics secures licensing deal to develop post-cancer treatment nausea therapy STAR-OLZ in China

“Oral lenalidomide has provided patients with multiple myeloma a life-changing therapy; however, many patients struggle with long-term tolerance which comes with a multitude of side effects,” said Dr Mohamad Hussein, a Starton board member and scientific advisor, in a statement.

“I think STAR-LLD will be the second coming of lenalidomide by avoiding the cycle of high and low drug levels caused by short half-life of oral administration while increasing efficacy with fewer side effects.”

Starton noted that each formulation candidate uses proprietary technology to enhance its solubility, stability, and permeability. And provisional patent applications have been filed. The invention includes a unique Method of Use with a pre-treatment to modulate the outermost layer of the skin reversibly and facilitate drug uptake.

“By overcoming the limits of how lenalidomide is dosed, we will potentially be able to help more people with multiple myeloma to benefit from this globally successful treatment in addition to those with chronic lymphocytic leukemia (CLL),” said Starton board member and scientific advisor, Dr Asher Chanan-Khan, who is also co-chairman of the Hematologic Malignancies Program at the Mayo Clinic Cancer Center.

“Dose-related side effects previously limited the success of oral lenalidomide formulations despite showing efficacy in CLL. STAR-LLD is likely to become the first immunomodulatory drug (IMiD) to treat this blood cancer and a potential breakthrough for patients by becoming the first maintenance therapy to help people stay in remission.”

Using a 505(b)(2) approval path with the US Food and Drug Administration, Starton said it is not anticipating having to repeat nonclinical safety studies. Once target blood levels and skin tolerability are demonstrated, Starton will select a lead candidate to advance into human clinical trials.

About STAR-LLD program

Starton said a pre-clinical proof-of-concept study for STAR-LLD demonstrated that tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with oral lenalidomide, and shrank by 80% with STAR-LLD.

It noted that high-risk smoldering multiple myeloma (SMM) is also a target indication for STAR-LLD after a randomized trial showed that 40% with SMM treated with oral lenalidomide discontinued due to drug-related side effects, despite 91% achieving three-year progression-free survival versus the 66% who were monitored without receiving active treatment.

In addition to a transdermal formulation, STAR-LLD is also in development as a continuous subcutaneous (SC) infusion of lenalidomide parenteral solution via an infusion pump. 

Starton said the STAR-LLD SC is expected to enter clinical studies in the fourth quarter of 2021, as it has completed a pre-IND meeting for STAR-LLD SC while its final IND-enabling study is currently underway.

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