Snippet roundup: Adocia fails, Nymox perseveres, FDA rejects Amgen and backs Impact

Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.

This week, 22-26 August 2016, we had thoughts on the following: Adocia boots foot ulcer project after trial failure; FDA knocks back Amgen’s Parsabiv; Nymox still hopes to inject life into BPH space; FDA backs Impact of concussion test.

These snippets were previously published daily via twitter.

Adocia boots foot ulcer project after trial failure

26 August 2016

Adocia’s phase III miss with its diabetic foot ulcer treatment is a disappointment to be sure, but it was a low-probability trial based on recent results of similarly acting projects. Last year saw the failures of two other assets, CureXcell and Aclerastide. Adocia’s Biochaperone PDGF-BB hoped to improve on the main platelet-derived growth factor product in this space, Regranex, by reducing patient exposure to the protein and halving the dose to once every other day. Adocia failed to show a statistically significant improvement in wound closure at 20 weeks compared with placebo. The French group’s big hope is its ultra-fast insulins, so it still has some important catalysts. Nevertheless, shares fell 6% today on news that the foot ulcer treatment had failed.

Setbacks in diabetic foot ulcer treatment
Company Project Outcome
Adocia BioChaperone PDGF-BB Phase III failed 2016
Macrocure CureXcell Phase III failed 2015
Derma Sciences Aclerastide Phase III failed 2015

FDA knocks back Amgen’s Parsabiv

25 August 2016

Amgen’s lifecycle management strategy has taken a blow with a complete response letter for Parsabiv, its Sensipar follow-on, in secondary hyperparathyroidism, a complication of chronic kidney disease. Amgen did not give more details on the reasons for the FDA’s rejection or say whether it needed to produce more data, but safety concerns are a possibility; a higher rate of cardiac failures was seen with Parsabiv versus Sensipar in a head-to-head trial, although the newer project did show better efficacy. Parsabiv is not Amgen’s most valuable pipeline asset, but with Sensipar set to come off patent in 2018 it could have done with a positive decision.

Amgen’s top five pipeline prospects
Prjeuct Indication Status 2022e sales ($m)
ABP 501 Rheumatoid arthritis/psoriasis Filed 810
Romosozumab Osteoporosis Filed 426
Parsabiv Secondary hyperparathyroidism Filed 404
AMG 334 Migraine Phase III 253
ABP 980 Breast cancer Phase III 148

Nymox still hopes to inject life into BPH space

25 August 2016

Nymox Pharmaceutical is persevering with its benign prostatic hyperplasia candidate fexapotide, but will extension data be enough to convince the FDA? The latest results, from a long-term blinded placebo crossover group – presumably from two US phase III trials that have already failed – found that fexapotide patients were significantly less likely to require surgery in the next two to three years compared with those who received conventional BPH treatments. Nymox plans to file for approval in the couple of quarters. The news sent the group’s share price up 83%, putting it not far off levels in 2014 before the pivotal studies – NX02-0017 and NX02-0018 – failed to show improvements in their primary endpoints, the international prostate symptom score and the American Urological Association symptom index respectively. The mechanism behind fexapotide, also known as NX-1207, has not been fully elucidated, but some researchers believe that the project, which is injected directly into the prostate, has anti-apoptotic properties.

Top-five BPH drugs in 2022
Drug Company Year launched Mechanism 2022e sales ($m)
Flomax Boehringer Ingelheim/Astellas 1996 Alpha 1 adrenoreceptor antagonist 784
Avodart GlaxoSmithKline 2003 Alpha 5 reductase inhibitor 341
Zalutia Nippon Shinyaku/Lilly 2014 Phosphodiesterase V inhibitor 134
Urorec Recordati 2010 Alpha 1 adrenoreceptor antagonist 133
Finasteride Mylan 2006 Alpha 5 reductase inhibitor 103

FDA backs Impact of concussion test 

23 August 2016

The FDA’s de novo approval pathway, designed for low-risk medical devices unlike anything that has come before, has ushered another innovation onto the US market. Immediate Post-Concussion Assessment and Cognitive Testing (Impact) assesses cognitive skills such as word memory, reaction time and word recognition to help evaluate patients with suspected concussion – for example at the side of a football pitch when a player has suffered a head injury. The Impact software, sold by the Pennsylvania group Impact Applications, runs on a computer and is intended for people aged 12 to 59; a version called Impact Pediatric, which runs on an iPad and is designed for children aged 5 to 11, has also been approved. Only healthcare professionals should perform the test, the FDA said, adding that clinicians should not rely on Impact alone to rule out a concussion or determine whether an injured player should return to a game.

FDA de novo clearances by year
Year Number Ave time (months)
2007 7 4.5
2008 3 6.0
2009 4 12.4
2010 3 14.4
2011 10 12.9
2012 10 15.3
2013 18 9.9
2014 28 13.7
2015 18 10.9
2016 to date 15 14.9*
*Approval time unavailable for the Impact test, so this has been excluded from this analysis.

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