Gilead Sciences (GILD) and Novo Nordisk A/S (NVO) announced that the companies intend to collaborate on a clinical trial combining compounds from their respective pipelines in nonalcoholic steatohepatitis, or NASH. The intended clinical trial will be a proof of concept study combining Novo Nordisk’s semaglutide and Gilead’s cilofexo and firsocostat for the treatment of patients with NASH. The companies are also exploring the potential to collaborate on preclinical research to advance understanding of the disease.
Friday, April 12, 2019
Forty Seven initiated at Guggenheim
Forty Seven initiated with a Buy at Guggenheim. Guggenheim analyst Michael Schmidt started Forty Seven with a Buy rating and $25 price target. The company is the scientific and clinical leader in targeting CD47, a novel mechanistic approach with “significant” market potential if successful, Schmidt tells investors in a research note. The analyst believes multiple early clinical-phase data readouts through 2019 may establish proof-of-concept in additional tumor types.
Spring Bank Pharmaceuticals presents results from ACHIEVE trial at ILC
Spring Bank Pharmaceuticals announced at The International Liver Congress, or ILC, results from the recently completed inarigivir Phase 2 dose escalation ACHIEVE trial for patients with chronic hepatitis B viru, or HBV. Spring Bank is developing inarigivir, an orally-administered hepatic-selective immunomodulator, as a potential backbone in a combinatorial treatment for chronic HBV with the goal to accelerate and substantially increase chronic HBV functional cure rates in a simple, safe and selective manner. In an oral presentation the company presented top-line results from all cohorts including the final 200mg dosing cohort. The data show that inarigivir continued to demonstrate a dose-dependent effect on HBV DNA and HBV RNA in the fourth cohort of the ACHIEVE trial over the 12-week dosing period. Inarigivir 200mg monotherapy dosing exhibited a mean decrease of 1.54log in HBV DNA with a range of 0.71log to 3.26log and a mean decrease of 1.14log in HBV RNA with a range of 0.08log to 4.88log. Inarigivir 200mg monotherapy showed a uniform antiviral response in all patients, in particular the high viral burden HBeAg-positive patients who had not responded to the lower doses of inarigivir monotherapy in the earlier ACHIEVE cohorts. In addition, across all patients HBV DNA and HBV RNA responses correlated with baseline HBsAg, baseline IP-10 and the decline of IP-10 at week 12, comparable to the clinical experience with interferon in chronic HBV. Across all four dosing cohorts, 16 of the 62 evaluable patients treated with inarigivir had a 0.5log or greater reduction in HBsAg at week 12 or week 24 and were categorized as responders. The mean reduction of HBsAg in this responder population was 0.8log with a range of 0.5log to 1.4log. Importantly, the HBsAg response to inarigivir in the ACHIEVE trial was genotype and host dependent. Although the number of patients was small, the HBsAg response seen in Genotype A and D was “excellent” with 4 of 5 patients responding. Genotype B and C were the most common genotypes and 33% of genotype B responded compared to 10% of genotype C. Two of the 3 genotype C patients that responded received 200mg inarigivir dose and belonged to the higher viral burden HBeAg-positive group. This amplified HBsAg response observed with inarigivir in genotype B compared to genotype C is comparable to the clinical experience of the immunomodulator interferon in the treatment of chronic HBV. The overall data from the ACHIEVE trial also revealed evidence of a shutdown of viral transcription by inarigivir in HBeAg-negative patients where HBV RNA was undetectable at week 12 in all patients treated with inarigivir at the 50mg, 100mg, and 200mg doses with a concomitant undetectable HBcrAg in the majority of these patients. At week 24, the HBV RNA and HBcrAg response was sustained with the switch to tenofovir disoproxil fumarate 300mg and associated with 18 of the 22 HBeAg-negative patients also having undetectable HBV DNA. Inarigivir was shown to be well tolerated at all doses in the ACHIEVE trial. Treatment-emergent adverse events ranged from mild to moderate in severity, with no investigator determined interferon-like side effects. The percentage of treatment-emergent adverse effects reported in the ACHIEVE trial was similar between the active and placebo groups. In the fourth cohort, one Grade 3 event was observed, but was not sustained on retesting, and there was one serious adverse event for knee pain hospitalization reported, but this patient was dosed with placebo. There were no other clinical or biochemical events above Grade 3 during the ACHIEVE trial. Spring Bank also announced the results from a healthy volunteer study that examined the potential for the use of the 400mg dose of inarigivir in chronic HBV patients. The results from this study revealed that inarigivir 400mg rapidly and uniformly increased activation markers of innate immunity on circulating peripheral monocytes and dendritic cells which was sustained over a ten-day period of dosing without evidence of tolerance. There was an associated activation of CD8+ t-cells and down-regulation of NK cells resulting in a potentially favorable adaptive immune profile for an antiviral response. The results from this study also demonstrated a lack of systemic cytokine activation secondary to the intra-hepatic targeting of inarigivir resulting in a favorable tolerability profile. These compelling immune-activation data for inarigivir, together with the dose-dependent effects on HBV DNA and HBV RNA and favorable tolerability profile observed up to 200mg daily in the ACHIEVE trial, serve as the basis for the recent launch of the Spring Bank global CATALYST trials in both treatment-naive and virally-suppressed chronic HBV patients. The CATALYST trials will focus on the examination of the 400mg dose of inarigivir.
Merus initiated at Guggenheim
Merus assumed with a Buy at Guggenheim. Guggenheim analyst Michael Schmidt assumed coverage of Merus with a Buy rating and $25 price target. The company has a “differentiated” bispecific antibody platform with rapid target screening and lead optimization technology, Schmidt tells investors in a research note. The analyst sees multiple clinical catalysts for the company through the second half of 2019 and “considerable potential upside to valuation if any single program is successful.”
Evofem price target raised to $11 from $9 at Oppenheimer
Oppenheimer analyst Leland Gershell raised his price target for Evofem Biosciences (EVFM) to $11 from $9 following yesterday’s announcement of the securities purchase agreement with PDL BioPharma (PDLI), which he says cures a significant financing overhang on favorable terms, mitigates uncertainty around U.S. commercial economics, and provides validation by a well-regarded strategic healthcare investor. He maintains an Outperform rating.
TRACON Pharmaceuticals terminates Phase 3 TAPPAS trial for futility
TRACON Pharmaceuticals announced that its Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient in patients with advanced or metastatic angiosarcoma was terminated for futility based on the recommendation of the Independent Data Monitoring Committee following its review of interim unblinded safety and efficacy data from more than 120 patients enrolled in the trial at the time of the analysis. TRACON will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.
Alkermes to hold a conference call
Conference call to discuss results from the ALKS 3831 ENLIGHTEN-2 Phase 3 Study, as well as interim results from the ongoing ENLIGHTEN-2 Extension Safety Study will be held on April 12 at 8 am.
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