ArQule ARQL Stock News

ArQule, Inc. (NASDAQ: ARQL) is flying in the market today with gains of more than 16% early on. The gains come after the company announced positive proof of concept data from its study of miransertib, also known as ARQ 092.

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ARQL Announces Positive Clinical Data

In a press release issued this morning, ArQule announced preliminary results from a Phase 1/2 study of miransertib. The study is being conducted to assess the potential of the candidate as an option for patients with PIK3CA-related Overgrowth Spectrum (PROS) and Proteus syndrome (PS).

The data was provided via an oral presentation at the European Society of Human Genetics Conference in Gothenburg, Sweden. The study centered in the release is an international, multi-center, open-label 2-part study.

In the first part of the study, ARQL is evaluating safety, tolerability, pharmacokinetic profile and preliminary evidence of clinical activity of miransertib at multiple dosing levels. The company said that it is expecting to begin the registrational part of the study in the third quarter of this year.

Positive Data

The data released today proved to be incredibly positive. In particular, ARQL said that the manageable safety profile was observed in patients as young as 2 years old. Moreover, most adverse events were Grades 1 or 2, suggesting that drug-related adverse events are minimal.

ArQule also said that the study demonstrated efficacy. In fact, the company saw improvement in disease related symptoms as measured by Karnofsy/Lansy scale in the majority of patients treated. Moreover, the majority of patients saw either improvement or no disease progression that lasted more than 1 year on treatment.

Important Commentary

In a statement, Dr. Brian Schwartz, Chief Medical Officer at ARQL, had the following to offer:

The results presented from our ongoing phase 1/2 study highlight the potential for miransertib to provide a molecularly targeted treatment for patients with rare PI3K/AKT driven overgrowth diseases.

We have been committed to rapidly advancing miransertib for patients with these devastating diseases since collaborating with The National Human Genome Research Institute in 2015 and are now poised to start the registrational study, MOSAIC, in the third quarter of this year. We are thrilled with the preliminary safety and clinical activity data and look forward to continued clinical progress for the program.

The above statement was followed up by Dr. Chiara Leoni, an investigator on the study. Here’s what Dr. Leoni had to offer:

The precision medicine approach of the study has led to very encouraging preliminary results with the observed safety and tolerability profile, along with clinically meaningful improvement in disease related symptoms in patients. In addition, the majority of patients have had stable disease while on treatment, demonstrating the potential of miransertib to halt disease progression.

The ability to attain durable treatment responses with a manageable safety profile is an important step forward for this patient population that currently has no medicinal treatment options, and I look forward to advancing the registrational MOSAIC study in the coming months.

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Final Thoughts

The news issued this morning proved to be incredibly positive. Unfortunately, PROS and PS are rare conditions with few treatment options available. While the development of miransertib is in early stages, should the drug be approved, it could prove to be the goose that lays the golden eggs for ARQL.

What Do You Think?

Where do you think ARQL is headed moving forward? Join the discussion in the comments below!

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