Your Daily Pharma Scoop: Tetraphase Positive Data, MediWound In Phase 3, Allergan Moves Up

Summary

Tetraphase presented positive data from Phase 3.

MediWound began enrollment of Phase 3.

Allergan presented positive Phase 2b/3 data.

Analysis Focus: TTPH

Tetraphase Pharma (TTPH) has a PDUFA on August 28 for its lead drug candidate ERAVACYCLINE in one indication - cIAI - complicated intra-abdominal infections. This PDUFA is based on an NDA filed on Feb 27 - the 6-month duration comes from a Fast Track designation; they also have a Qualified Infectious Disease Product (‘QIDP) for the drug candidate.

The NDA itself is based on positive phase 3 data that was published in July, 2017. This study, IGNITE4, showed that ERAVACYCLINE is non-inferior to meropenem, which has long been used to treat cIAI. The drug modality was twice-daily IV, and the trial enlisted 500 patients.

Yesterday, more news came out that shows there’s considerable chances of success for ERAVACYCLINE in the PDUFA. The data, presented at Microbe 2018 in Atlanta, GA, was as follows:

“For patients with cIAI caused by Enterobacteriaceae, the overall favorable clinical and microbiological response rates were 88.2% and 86.3%, respectively and 100% for patients with cIAI caused by A. baumannii . Notably, in patients with infections due to extended spectrum beta-lactamase producing Enterobacteriaceae, eravacycline demonstrated a favorable microbiologic response rate of 88.9%.”

What is important about non-inferiority to an existing SoC is that bacterial multi-drug resistance (‘MDR) is soon slated to attain epidemic proportions, according to a threat analysis done at Center for Disease Control and Prevention (‘CDC). So, the ability to treat the same bacterial disease with a different type of antibiotic has singular importance.

Tetraphase is a clinical stage life science company with a synthetic chemistry technology platform and a $202.906M market cap. Founded in in 2006, the company has focused on developing a robust chemistry platform of tetracycline core chemical structure. This platform is based on a fully synthetic approach pioneered at Harvard. The company has synthesised over 3,000 tetracycline analogues using this platform.

TTPH has a focus on treatment of serious and often multi-drug resistant (‘MDR) Gram-negative bacteria. Many bacteria are turning drug-resistant, and diseases that were once considered to be rare are now bouncing back to ominous regularity. Hence the need to produce advanced generations of antibiotics to combat such bacteria has become a dire necessity.

Tetraphase has a strong pipeline with three candidates. The lead candidate is Eravacyclin, a broad-spectrum antibiotic undergoing trials for MDR Gram-negative bacteria. Eravacyclin is being tested on two conditions: complicated intra-abdominal infections and complicated urinary tract infections (‘cUTI). The company has positive data for cIAI, but did not attain non-inferiority with SoC in its cUTI trial.

TTPH stock plunged in February after release of the cUTI data, but is slowly revving back up in anticipation of the PDUFA. There is probably still time based on the fact that it is still trading halfway to its 52-week high. According to some analysis, eravacycline is targeting a total market size of $700mn.

Stocks in News: MDWD, AGN

MediWound completes enrollment in late-stage study of NexoBrid

Discussion: MediWound (NASDAQ:MDWD) enrolled 175 subjects in Phase 3 study of its NexoBrid management of severe burn and wound. Earlier a Europe-based Phase 3 study showed 96.3% rate of eschar removal (called debridement) with NexoBrid. Current Phase 3 trial has primary endpoint of complete eschar removal compared to SOC. Assessment of long term impact can be done at 12 and 24 months.

An older data puts the figure of severe burn injuries and wound to ~1.5M. Almost half of these cases also require hospitalization. Among the many factors that contribute in a significant way towards revival from severe burn and wounds is debridement. Overall treatment conditions of severe burn and wound have dramatically improved leading to making the number of death from burn and wound to almost half it was previously. However, increasing incidence of burn-related injuries is the major factor driving the market growth in near future. In 2016 the global burn care market size was estimated ~$1.66 billion in 2016 and is expected to grow at CAGR of 6.4% to touch $2.87 billion by 2025.

Allergan's atogepant shows positive effect in Phase 2b/3 migraine study

Discussion: Allergan’s (NYSE:AGN) second orally-administered CGRP receptor antagonist atogepant for the prevention of migraine completed its Phase 2b/3 clinical trial. The candidate met the primary endpoint across all doses and dose regimens. Reduction from baseline in monthly migraine or probable migraine headache days against the placebo is statistically significant. The candidate is now moving to the Phase 3 as per original timeline. Earlier company’s first oral CGRP antagonist ubrogepant successfully concluded its late-stage study. The company claims that the present candidate atogepant is chemically different from the earlier candidate ubrogepant. The former will be more suitable as a preventive treatment.

Globally migraine ranks as the seventh most disabling disease among all diseases and the leading cause of disability among all neurological disorders. It may sound counter-intuitive, but its estimated global prevalence is ~15% and such a high rate of prevalence makes it more common than diabetes, epilepsy and asthma combined. Over the last year the market for migraine drugs is supercharged with numerous new drugs making their appearance and more planning to join soon from the pipeline. Recent estimates put the figure of approximate sales in the migraine market at ~$3.3B. The market is further expected to expand at a CAGR of over 10% to touch ~$8.5B by 2026.

In other News

Phase ½ results of GT Biopharma's (OTCQB:GTBP) OXS-1550, a bispecific antibody-drug conjugate, in patients with treatment-resistant B-cell lymphomas (NHL) and leukemias (ALL) showed a treatment effect.

Two studies published in Nature Medicine appear to report of cancer risk with gene-editing technology. Anticipation created by the report pushes all three leading gene-editing technology companies CRISPR Therapeutics (NASDAQ:CRSP), Editas Medicine (NASDAQ:EDIT) and Intellia Therapeutics (NASDAQ:NTLA). See our article from yesterday.

Two different Phase 2 clinical trials, assessing Merck KGaA's (OTCPK:MKGAF) tepotinib for the first-line and second-line treatment of patients with MET-positive advanced hepatocellular carcinoma (HCC) with reasonably functioning livers met the primary endpoints.

Aquinox Pharmaceuticals (NASDAQ:AQXP) begins a Phase 2 proof-of-concept clinical trial assessing once-daily rosiptor (formerly AQX-1125) for the treatment of chronic prostatitis ('CP) and chronic pelvic pain syndrome (‘CPPS). Currently there are no FDA-approved treatments for the condition.

Arcus Biosciences (NYSE:RCUS) announced that the FDA had signed off on its INDs for AB928 and AB122. The company plans to launch a Phase 1/1b study assessing the safety, tolerability and initial efficacy of AP928, combined with other agents (including AB122), in patients with breast and gynecologic cancers.

Pfenex (NYSEMKT:PFNX) announced its deal with Alvogen for exclusive U.S. commercialization rights to PF708, a proposed biosimilar of Eli Lilly's (NYSE:LLY) Forteo [teriparatide (rDNA origin) injection].

Endo International (NASDAQ:ENDP) announced a settlement agreement resolving all known product liability claims against it related to testosterone replacement therapy (NYSEMKT:TRT).

VistaGen Therapeutics (NASDAQ:VTGN) announces that the Japanese Patent Office has issued a Notice of Allowance for a patent covering certain methods for producing blood cells, platelets and bone marrow stem cells. The Japanese patent is similar to U.S. Patent No. 9,834,754 awarded in December 2017.

First patient of Phase 1 clinical trial of Advaxis' (NASDAQ:ADXS) ADXS-NEO, dosed in patients with metastatic non-small cell lung cancer (‘NSCLC), metastatic microsatellite stable colon cancer and metastatic squamous head and neck cancer.

LivaNova (NASDAQ:LIVN) announced that the Japanese Ministry of Health, Labor and Welfare has approved its Perceval sutureless aortic heart valve to treat aortic valve disease. It was approved in the U.S. in 2016.

OPKO Health (NYSEMKT:OPK) enrols 110 subjects in its Phase 2b clinical trial of injectable GLP-1 and glucagon dual agonist OPK88003 in patients with type 2 diabetes (T2D).

The FDA has approved the addition of overall survival (‘OS) data from the Phase 3 ASPIRE study to the labeling of Amgen's (NASDAQ:AMGN) KYPROLIS (carfilzomib).

Alexion Pharmaceuticals (NASDAQ:ALXN) concludes agreement with Amsterdam-based privately held Complement Pharma to co-develop CP010, a C6 complement inhibitor for the potential treatment of neurodegenerative disorders.

Correvio Pharma (NASDAQ:CORV) announced that the FDA has signed off on the refiling of a marketing application for antiarrhythmic drug BRINAVESS (vernakalant hydrochloride).

Neuralstem (NYSEMKT:CUR) awarded Phase I SBIR contract to support research into neural stem cell therapy for severe TBI.

Translate Bio (TBIO) signs multiyear R&D and licensing agreement with Sanofi (NYSE:SNY) aimed at developing mRNA vaccines for up to five undisclosed infectious disease pathogens.

Can-Fite BioPharma (NYSEMKT:CANF) announced positive preclinical data on NAFLD/NASH candidate namodenoson.

Vical (NASDAQ:VICL) announced failure to achieve the primary endpoint of Phase 2 trial of its herpes simplex virus type 2 (HSV-2) therapeutic vaccine candidate, VCL-HB01.

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