Valeritas Holdings Inc (NASDAQ: VLRX) is flying in the market today after announcing top-line results from a clinical trial looking into its V-Go wearable insulin delivery system. Here’s the deal:

VLRX Announces Clinical Data

Valeritas Holdings is flying today in the market after the company announced data from a clinical trial. The trial, known as the ENABLE, or EffectiveNess of V-Go WeArable Insulin Delivery for Basal-BoLus ThErapy, proved to be a source of validation of the efficacy of V-Go. In fact, the data show that patients who switched from traditional insulin pens and syringes to V-Go not only saw significant improvements in blood glucose level, but also used a reduced dose of insulin to achieve this milestone.

The data was provided by VLRX through three poster presentations at the American Diabetes Association Meeting in Orlando, Florida. Here are the key points from the poster presentations:

Poster 988 – EffectiveNess of V-Go WeArable Insulin Delivery for Basal-BoLus ThErapy (ENABLE) Study: A Multicenter Retrospective Real World Evaluation in Type 2 Diabetes

In the first poster presentation from the ENABLE Study, clinical benefits in patients with type 2 diabetes who made the switch to V-Go insulin delivery from traditional methods of insulin delivery were evaluated. The data showed statistically significant reductions in A1C by over 1%. Also, the percentage of patients at high risk was reduced by around half after switching to V-Go. Finally, over 50% of patients included in the study achieved a key milestone of A1C levels at less than 8%. Finally, after three and seven months, significant reductions weren’t only seen in A1C, but also in TDD, suggesting incredible efficacy of the V-Go insulin delivery system.

In a statement, lead author and endocrinologist, Ripu Hundal, M.D., of First State Endocrinology in Newark, Delaware had the following to offer:

We categorize patients with an A1C above 9.0% as high risk since they are more likely to have long-term complications that impact health care costs. The significant reduction in A1C and the achievement in A1C goals after switching to V-Go in the ENABLE study has important implications for treating diabetes. By improving glycemic control, our hope is to reduce rates of complications as well as decrease health care cost, which is a priority for all healthcare systems.

Poster 989 – Achievement of Glycemic Targets when Switching from Basal-Bolus Therapy to V-Go for Insulin Delivery in Type 2 Diabetes. 

The second poster presentation provided by VLRX was an analysis from the ENABLE study that confiremed that V-Go provided a clinical benefit in a patient population that was previously poorly controlled on conventional basal-bolus therapy delivered by multiple daily injections (MDI) using insulin pens and syringes.

In this analysis, data from 16 patients with type 2 diabetes demonstrated that at three months, A1C was reduced by -1.0. This result was sustained at seven months. Also, data showed that insulin TDD was reduced by 30% with the use of V-Go.

In order to determine if TDD was a factor in the change in A1C, patients were divided into three groups that were approximately equal in size. The groups were based on baseline TDD (< 60 U/day [mean of 46 U/day], 60 to 90 U/day [mean of 72 U/day], or > 90 U/day [mean of 134 U/day]). Ultimately, the results showed statistically significant reductions in A1C across all TDD groups of -1.0, -0.8, and -1.2 respectively.

Poster 990 – Clinical Outcomes With V-Go in Type 2 Diabetes based on Duration of Diabetes

The third and final poster presentation from the ENABLE study evaluated the impact of duration of diabetes on change in A1C and insulin TDD when patients switch to V-Go. Patients included in the study were split into five groups based on how long they have had diabetes. The data show that clinically and statistically significant reductions in A1C at both three and seven month intervals took place across all five duration of diabetes groups. All groups also saw reductions in TDD with the exception of the duration group with the lowest baseline TDD (15 to 20 years). This group maintained a similar dosing on V-Go compared to baseline.

In a statement, laed author, Jane Cases, M.D., of Marietta, Ohio, had the following to offer:

Findings from the ENABLE Study demonstrated that no matter how long a patient had been diagnosed with diabetes, switching to V-Go from insulin delivery via insulin pens and syringes resulted in significantly lower A1C levels. We believe this positive data demonstrates that diabetes duration should not be a factor when determining which patient can benefit from using V-Go.

Of course, with the overwhelmingly positive data being offered by VLRX, CEO John Timberlake was overwhelmingly pleased, saying the following:

The largest study of V-Go patients to date has demonstrated that regardless of baseline insulin dose or duration of diabetes, patients who switched to V-Go significantly lowered their blood glucose. We believe that is significant for diabetes patients, their medical professionals, payors, and Valeritas.

We recently reported our third consecutive quarter of record revenue which is a direct result of V-Go gaining momentum among patients with type 2 diabetes. V-Go is discreet, simple-to-use, cost-effective, clinically proven, and the only disposable, daily insulin delivery option.

Investors Are Excited

With the news of the positive clinical data surrounding V-Go, investors are clearly excited as they send the stock on a run for the top. At the time of writing this article (11:16), VLRX was trading at $1.86 per share after a gain of $0.44 per share or 30.94%.

Risks And Rewards

Any time we make an investment, it’s important to think about both the risks and rewards. Here’s what to think about when looking into VLRX:

Risks

  • First and foremost, Valeritas Holdings is a clinical stage biotechnology company. This comes with some risk. First and foremost, as a clinical stage company, the company doesn’t currently have regulatory approval for its products. As such, it is not generating any revenue from its products at the moment.
  • Also, there are various risks associated with the company being able to bring their products to market. While clinical data is showing promise, until these products are approved, there’s always the risk that something goes wrong in a study, leading to assets being abandoned.
  • Financially, as a clinical stage company, VLRX is heavily dependent on both its investors and its lenders. Without these sources of funding, the company wouldn’t have the money it needed to advance its clinical pipeline.

Potential Reward

While every stock has its risk, VLRX also comes with some serious potential for rewards. Think about it, the diabetes market is a massive one. In fact, about 9.3% of the population in the United States has diabetes. Importantly, if data stays consistent, Valeritas Holdings may be able to take the market by storm. After all, few patients or medical professionals will say no to an option that requires less medicine and generates better results than traditional methods. Therefore, the potential for VLRX to become a massive value driver for investors is strong.

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