Your Daily Pharma Scoop: Conatus Setback, Applied DNA Signs Agreement, Evolus Announces Results From Late-Stage Study
- Conatus’ POLT-HCV-SVR study fails.
- Applied DNA Sciences signed a License and Collaboration Agreement and related Supply Agreement.
- Evolus announces results from EVB-003.
Analysis focus: Conatus
Conatus (NASDAQ:CNAT) shares tumbled after the company announced top-line results from a phase 2b POLT-HCV-SVR clinical study. The phase 2b study was evaluating CNAT’s lead product candidate emricasan, a first-in-class pan-caspase protease inhibitor designed to reduce the activity of human caspases in liver transplant patients with fibrosis or cirrhosis. It is one of the four studies CNAT is currently conducting with its lead product candidates. The most anticipated data will be from the ENCORE-LF study (due in the second half of 2019).
We covered CNAT as part of our NASH series back in February. As we had noted back then, what makes emricasan exciting is the fact that it is targeting a spectrum of the NAFLD/NASH disease where the space is not yet crowded. A majority of NASH players are focusing on NASH fibrosis. With emricasan, Conatus is targeting a full range of fibrosis and cirrhosis, including decompensated cirrhosis. Currently, none of the NASH players are targeting NASH with decompensated cirrhosis. This makes the results from the ENCORE-LF trial very important.
The POLT-HCV-SVR study did not meet the primary endpoint in the heterogeneous overall trial population, the emricasan treatment effect in the subgroup of patients where the histology endpoint is most relevant. Patients with advanced fibrosis and early cirrhosis supports further evaluation. While this is a setback for CNAT, it must be noted that this study has a separate patient population vs. the other three Phase 2b clinical trials in the company’s collaboration with Novartis (NVS), which are in non-viral indications in patient populations with nonalcoholic steatohepatitis (NASH) fibrosis or cirrhosis. As we also noted, the ENCORE-LF study is the most important for CNAT.
We believe that the sell-off creates a good opportunity to add some CNAT shares, which had a good run in March before the sell-off in the broader market.
Stocks in the news: Analysis of APDN, EOLS
Applied DNA Sciences (NASDAQ:APDN) announced that it signed a License and Collaboration Agreement and related Supply Agreement effective March 31 with Colorcon Inc.
Analysis: As per the terms of the agreement, Applied DNA has granted exclusive worldwide right to use the company’s molecular tags and associated authentication technologies in film coatings for solid oral dosage form (SOD) applications, and non-exclusive rights to use the company’s technologies in inks and colorants for SOD applications. Pursuant to the agreements, Applied DNA's exclusive worldwide rights cover use of the company’s molecular tags and associated authentication technologies in film coatings for solid oral dosage form (“SOD”) applications, and non-exclusive rights to use the company’s technologies in inks and colorants for SOD applications.
Evolus (NASDAQ:EOLS) announced results from a phase 3 study, EVB-003, that showed the non-inferiority of the company’s prabotulinumtoxinA 900 kilodalton (kDa) to Allergan's (NYSE:AGN) OTOX (onabotulinumtoxinA) in patients with moderate-to-severe glabellar lines (frown lines). The data were presented at the Aesthetic & Anti-Aging Medicine World Congress in Monte Carlo, Monaco.
Analysis: The 150-day, 540-subject study evaluated a single dose of prabotulinumtoxinA compared to a single dose of BOTOX. The primary endpoint was the proportion of subjects with a Glabellar Line Score (‘GLS) of 0 (no lines) or 1 (mild lines) at maximum frown at Day 30 as assessed by the investigator. The responder rates for prabotulinumtoxinA, BOTOX and placebo were 87.2%, 82.8% and 4.2%, respectively. The rates of adverse events were similar between prabotulinumtoxinA and BOTOX (15.5% vs. 14.6%).
In other news
Cellectis (NASDAQ:CLLS) announced that it has priced its public offering of 5.65 million ADS at a price of $31.00 per ADS. Underwriters to the offering have been granted an option to acquire an additional 847,000 shares to cover for over-allotment, if any.
Antares Pharma (NASDAQ:ATRS) announced that the FDA has confirmed the receipt of its efiled marketing application seeking approval for XYOSTED (testosterone enanthate subcutaneous injection) for men with low testosterone. The agency's action date is September 29.
AC Immune (NASDAQ:ACIU) announced that several Tau Morphomer candidates have demonstrated target-specific reduction of pathological Tau and cognitive and functional improvement in Alzheimer's disease in preclinical testing.
VistaGen Therapeutics (NASDAQ:VTGN) announced that it has initiated ELEVATE, a placebo-controlled phase 2 study to evaluate the efficacy and safety of AV-101 (L-4-chlorokynurenine) as an adjunctive treatment of Major Depressive Disorder (MDD) in patients with an inadequate response to current antidepressants approved by the FDA.
Biogen (NASDAQ:BIIB) and its development partner Samsung Bioepis announced the resolution of a patent dispute with AbbVie (NYSE:ABBV) over its HUMIRA (adalimumab) biosimilar. As per the terms of the settlement, AbbVie will grant patent licenses for the biosimilar, branded as IMRALDI, in Europe on a country-specific basis. Biogen and Samsung Bioepis will make royalty payments to AbbVie. Specific financial terms are not disclosed.
Intercept (NASDAQ:ICPT) announced that it has priced its public offering of 2,343,750 shares of common stock at $64 per share. Underwriters to the offering have been granted an option to acquire an additional 351,363 shares to cover for over-allotment, if any. ICPT also agreed to directly sell approximately 1.6 million shares to certain investors at the same price.
Aradigm (NASDAQ:OTC:ARDM) announced that the European Medicines Agency has accepted for review its marketing application seeking approval for Linhaliq (ciprofloxacin for inhalation) for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
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