Provention Bio's CEO On Identifying Autoimmune Diseases 'Before It's Too Late'

When it comes to treating chronic, immune-mediated diseases, the standard course is to wait for symptoms before beginning treatment. But by that point, it may be too late for intervention. These diseases can silently do irreversible damage, according to Provention Bio Inc PRVB CEO Ashleigh Palmer.

“We came together as seasoned industry executives because we were unhappy with how the medical system manages and develops therapies for autoimmune diseases,” Palmer told Benzinga.

Provention’s goal is to identify patients in early stages of rheumatoid arthritis, Type 1 diabetes and other autoimmune diseases — and delay their progression. In doing so, the company hopes to preserve patient joints, pancreatic beta cells and other attacked or deteriorated systems.

“If we interrupt and intercept a disease early enough, the symptoms are different, and we can in many instances prevent the end stages and tissue damage that result,” the CEO said.

“We want to identify a disease before it’s too late, before they have to have therapy for a lifetime to manage their symptoms.”

Provention's Leading Candidate

Provention’s lead candidate teplizumab is in late-stage trials to delay the onset of Type 1 diabetes, a disease that Palmer said has seen no treatment innovation since the introduction of insulin a century ago. 

The company is testing antibodies in the relatives of patients with the disease to identify an estimated 30,000 to 40,000 at-risk Americans and proactively remove their overactive T cells.

“We got an amazing increase in the time to the clinical diagnosis of the disease compared to placebo by at least two years,” he said of early trial results.

Provention is on track to submit a BLA for teplizumab for at-risk patients in the fourth quarter and it anticipates an FDA decision by mid-2021. In the meantime, it is working to screen the general population without affected relatives and to intervene in the disease for the 60,000 patients a year who are newly diagnosed.

At this point, the company is still evaluating pricing based on comparative therapies, but its benchmark for the drug is the $100,000 cost of a course of multiple sclerosis therapy.

Provention's Pipeline Prospects

The company's secondary candidates include PRV-3279 for the prevention of virus immunogenicity and the interception of lupus, which affects 300,000 Americans with an unmet need.

Chief Scientific Officer Francisco Leon said the drug may be able to address similar indications triggered by overstimulated B cells, such as rheumatoid arthritis or multiple sclerosis.

Leon also sees potential for PRV-015 to become the first approved treatment for celiac disease, which affects 3 million Americans.

Provention will launch a Phase 1 study on a vaccine for coccaci B virus by the end of 2020 to prevent acute infections like pericarditis and hand-foot-mouth disease. The vaccine would preempt about 2 million infections a year, according to the company. 

Palmer said he is “comfortable building markets” and is open to expanding the pipeline beyond current indications. Provention’s general strategy is to acquire promising therapies, many of which have established safety profiles, the CEO said.

“We plan to continue to do that.”  

In the meantime, Palmer said the “therapeutics in the pipeline have good lifecycle strategies.”

For example, teplizumab could be administered alongside other cell therapies to protect transplanted cells, or it could be developed to address other T-cell-related autoimmune diseases, he said.

Provention's Potential Partnerships

Provention is working with Amgen, Inc. AMGN and Johnson & Johnson JNJ-owned Janssen on its celiac program, and it’s eyeing additional partners.

“We’re constantly evaluating partnerships and of different natures, not just strategic pharmaceutical companies,” Palmer said, referencing research funder JDRF and patient advocacy groups.

If the FDA approves teplizumab, Provention would lead commercialization efforts in North America, but for sales in Europe, Palmer is looking for a partner.

“We don’t intend under any circumstances to build infrastructure outside the U.S.,” he said.

Provention's Financial Health

Provention had to pause at least one program due to the coronavirus, but it feels comfortable with its cash on hand to weather the extended lockdowns.

It closed 2019 with $85 million in cash — “enough to get through the middle of next year,” CFO Andy Drechsler said.

“We will need more capital to fund the commercialization of teplizumab in the U.S., so as long as the capital markets are functioning, we feel good about where we’re at,” Dreschler said.

He anticipates a capital raise later this year in the near-to-mid term. Provention last completed a secondary offering in September.

Provention shares were trading 6.34% higher at $11.40 at the time of publication Tuesday.

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