This Week In Pharma: What Can We Expect From Upcoming Phase 2 Data For Seres Therapeutics' C.Difficile And Neurocrine Biosciences' Tourette Drugs?

| About: Neurocrine Biosciences, (NBIX)

Summary

Pharma Hot Topic Match-Up:MCRB Vs. NBIX. Based On Your Votes For The Most Interesting Topic, Slingshot Insights Will Sponsor An Expert Interview That You Can Join For Free.

Option 1: Discussing the upcoming Phase 2 results Seres intends to release for their Clostridium Difficile Infection drug SER-109. Could this become the new standard of care?

Option 2: Reviewing Neurocrine’s impending Phase 2 results for treating Tourette Syndrome with Valbenazine. What can we expect data-wise and what could this mean for the market?

By Killian McKee, Slingshot Contributor

This week covers upcoming Phase 2 results from Seres Therapeutics (NASDAQ:MCRB) and Neurocrine Biosciences (NASDAQ:NBIX).

Seres anticipates releasing Phase 2 results for its CDI drug SER-109 mid-2016. Having already passed the midpoint of the year, these results should be coming within the next few weeks. Investors should take note, current CDI drugs are often ineffective and the market grows larger each year. Option 1 takes a hard look at SER-109 for CDI and raises some questions about MCRB where a subject matter expert's views could prove insightful.

Neurocrine foresees its Phase 2 data for two studies examining the efficacy of treating Tourette Syndrome with Valbenazine arriving by the end of 2016. Why might pharma investors care? TS is a common, not entirely understood disease with a large underserved market. Option 2 expands on NBIX's potential TS drug and poses expert questions regarding the upcoming data.

Option 1: Discussing the upcoming Phase 2 results Seres intends to release for their Clostridium Difficile Infection drug SER-109. Could this become the new standard of care?

What's the Situation?

The CDC classifies CDI as one of the top 3 most pressing antibiotic-resistant bacterial risks facing the U.S. CDI occurs when the balance of Clostridium difficile "c. diff." bacteria, typically present in the gastrointestinal tract, become upset. Common causes of CDI include taking antibiotics, hospitalization, living in nursing homes, GI surgery, coming into contact with people who have the disease, and inflammatory bowel diseases. Symptoms are serious bouts of diarrhea, abdominal pain, fevers, and bloody stool. The market for CDI is massive; the CDC estimates almost half a million infections occurred in 2015 with around 28,000 being fatal.

To make matters worse, current antibiotic and fecal transplant treatments have unimpressive success rates, are expensive, or time consuming to give (e.g. some fecal transplants require a doctor to make a patient swallow 32 pills). Recurrence occurs in 15-35% of patients after their first bout of CDI. The rate rises to 35-65% after the first recurrence. Clearly, a sizable opportunity exists for any pharmaceutical company capable of producing a drug to effectively tackle recurrent CDI.

What's MCRB's Response?

MCRB believes it may have developed the first therapy addressing the underlying bacterial imbalance causing recurrent CDI. The drug utilizes Seres' Microbiome Therapeutics platform, which aims to identify key microbiome imbalances and then correct them via an oral capsule filled with spores of the missing bacteria. This would be the first microbiome drug used to treat a human disease.

What Does Previous Data Show?

A Phase 1b/2 trial of SER-109 showed promising initial results. 97% of patients achieved a clinical cure during the eight-week period after SER-109 dosing (defined by a lack of CDI requiring further antibiotic treatment). Conversely, expected cure rates for people treated with current antibiotics for recurrent CDI range from 23-31%

What Else Should You Know?

• Seres recently initiated a Phase 1 trial for SER-262, another microbiome drug aimed at treating primary CDI.

What's the Next Step?

Speaking with a gastrointestinal expert. By talking to a gastroenterologist with experience treating CDI, investors could gain a valuable window into the science of SER-109 and the larger impact it might have on CDI treatment.

Questions for a CDI Expert:

1. What is your background treating CDI? Have your patient numbers been increasing or decreasing over time? What types of patients do you typically see?

2. What are the greatest obstacles you see to treating CDI? Are there any treatments you see coming through the pipeline with the capability to resolve these issues?

3. What are currently your preferred methods for treating CDI? What do you see as their shortcomings/upsides? What sorts of success rates are you seeing in the treatments you employ? What are you looking for in your ideal treatment?

4. Could a drug used to treat recurrent CDI ever be used to treat primary CDI? Is there a major difference between primary and recurrent CDI? If not, is the market for recurrent CDI significant? How frequently do you see patients failing the initial course of therapy for primary CDI?

5. What are your thoughts on the microbiome science behind SER-109? Does it sound plausible to you?

6. What are your general thoughts on the SER-109 data thus far? Did you find any points of concern or interest?

7. Given the increasing adoption of fecal transplants for patients failing antibiotic treatment, what are your thoughts on drugs like SER-109? Which would you prescribe if both were on the market?

8. Do you see any unique attributes to SER-109 that would help or hurt it in Phase 2? How do you expect the Phase 2 trial to go? Given your knowledge of the drug, how likely do you think approval is for SER-109?

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Conclusion

Seres' SER-109 trial deserves attention due to the highly underserved CDI market. Speaking with an expert about this dangerous bacterial disease could help investors glean more information about the science behind the drug and what approaching data might say.

Option 2: Reviewing Neurocrine's impending Phase 2 results for treating Tourette Syndrome 'TS' with Valbenazine. What can we expect data-wise and what could this mean for the market?

What's the Situation?

Tourette syndrome is a neurological disorder categorized by repetitive involuntary vocalizations and movements (tics). The symptoms of TS typically manifest themselves in early childhood, worsen significantly in the early teens, and then improve into the late teens and adulthood. The CDC estimates as many as 1 in 162 children may suffer from TS, with a significant portion carrying their tics into adulthood (around 10-15%). It is estimated around 200,000 Americans have the most severe form of TS.

Current treatments attempt to suppress tics. Some of the most common tic suppression methods are ADHD medications, medications that limit dopamine production, behavioral therapy, and even surgery to implant an electrical device into the brain. Although there is a wide range of options available, there is no widely agreed upon standard of care. Many of these treatments have significant side effects. The TS market has the potential to be upset by a drug that can differentiate itself from the current pack of "so-so" treatments.

What's NBIX's Response?

NBIX is exploring using Valbenazine as an improved way to treat the symptoms of TS. Like some existing treatments, Valbenazine reduces dopamine production levels by inhibiting a dopamine transporter (VMAT2). Unlike current offerings, Valbenazine does not block a broad range of dopamine transporters (e.g. VMAT1). NBIX believes this selectivity may reduce the likelihood of severe side effects and improve patient outcomes.

What Does Previous Data Show?

Previous Phase 1 trial data from NBIX's Valbenazine T-FORCE study demonstrated promising results for children and adolescents. The study showed a 31% mean reduction in symptoms based on The Yale Global Tic Severity Scale.

What Else Should You Know?

• NBIX is studying Valbenazine via two separate Phase 2 trials for TS: one treats children and adolescents, the other targets adults.

• NBIX also has ongoing Valbenazine trials for tardive dyskinesia, a nervous system disorder often caused by long term psychiatric drug use.

What's the Next Step?

Interviewing a psychiatry or neurology expert with a focus on TS and an understanding of Valbenazine. This should give investors valuable insights into the data we've already received from NBIX and what we can look forward to from Phase 2.

Questions for a TS Expert:

1. What is your background treating TS? How many patients do you typically treat with the disease? What age range do you typically see?

2. What are the biggest problems you see with current TS treatments? What do you currently use? Are there any potential or upcoming treatments you are excited about?

3. Do you find the science behind Valbenazine's selective dopamine transporter inhibition compelling? Why would blocking the VMAT2 mechanism make the most sense vs others like VMAT1? Do you have concerns about the side effects this type of action mechanism could cause?

4. What are your general thoughts on the data thus far? Do you see any potential points of concern or obstacles the data raises?

5. What would you expect to see from the Phase 2 data based on what we've seen from T-FORCE? Would you expect a significant difference in how this is tolerated in adults vs children?

6. What are your thoughts on NBIX's trials for SER-109 in Tardive Dyskinesia? Is this market significant? Would you expect this drug to work in these types of patients as well?

7. How likely do you think it is Valbenazine will be approved? How quickly do you think it would make it to market? What sort of market share do you think a drug like this would receive?

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Conclusion

NBIX's multiple TS Phase 2 Valbenazine trials deserve attention from investors. The drug has demonstrated potential via Phase 1 and could become the standard of care for an underserved, prevalent disease depending on the outcome of Phase 2 and 3. Speaking with a neurological expert could elucidate the likelihood of this outcome.

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