Pharmaleads Announces the Opening of French Sites in Its International Phase IIa Clinical Study of PL37

ANSM (French National Agency for Medicines and Health Products Safety) authorizes the extension of the clinical trial for pain in diabetic neuropathy

PARIS--()--Pharmaleads, the biotech company developing its proprietary Dual Enkephalinase Inhibitors (DENKIs) for the treatment of severe pain, announces today the opening of the first French investigative sites in the Phase IIa clinical study of oral PL37 for pain in diabetic neuropathy.

Review of the study:

  • Great Britain: 11 active sites
  • France: 6 diabetology sites: Centre Hospitalier Universitaire (CHU) Lyon-Sud, coordinating centre, Centre Hospitalier Universitaire (CHU) de Nantes, Centre Hospitalier Sud Francilien in Corbeil Essonnes, Centre Hospitalier Régional Universitaire de Nancy, Centre Hospitalier Universitaire de Caen and Centre Hospitalier de Valenciennes.
  • Bulgaria: pending regulatory approvals

According to Michel Wurm, MD, Corporate Development Director at Pharmaleads: "This clinical study for the PL37 proof of concept is evolving according to the provisional schedule. The enthusiasm and commitment among the investigators confirm their interest in DENKIs, a new class of analgesics for which PL37 is paving the way. In a field where no first-line treatment has obtained marketing authorization since Lyrica® in 2004, this drug candidate offers real prospects for the treatment of neuropathic pain."

Dr Julien Vouillarmet, diabetologist at the Centre Hospitalier-Universitaire Lyon-Sud, Coordinator of the clinical study in France, says: "Today, the standard treatments do not provide sufficient relief of neuropathic pain in diabetic patients. This is why I am very proud to be coordinating this clinical study on DENKIs which represent a new path for the treatment of neuropathic pain that will bring, I hope, a real benefit for patients."

European development
This Phase IIa study of PL37 follows a major Phase I program which demonstrated the tolerance and safety of PL37 in 136 healthy volunteers. This proof of concept trial started in April 2015 in eleven British hospitals.
After France, four sites will be opened for recruitment in Bulgaria, for a total of 21 investigative sites in the three countries.

The clinical study
This on-going clinical study recruits patients with diabetic neuropathy and incomplete pain relief provided by Lyrica® or gabapentin, the most commonly prescribed treatments for neuropathic pain and for which considerable synergy with DENKIs has been demonstrated in pharmacology studies.

DENKIs: http://www.pharmaleads.com/our-pipeline/therapeutic-focus/

Neuropathic pain: http://www.pharmaleads.com/our-pipeline/neuropathic-pain/

The market for Pharmaleads DENKIs: http://www.pharmaleads.com/our-pipeline/future-developments/

About Pharmaleads: http://www.pharmaleads.com/abouts-us/vision-mission/

Articles on DENKIs recently published by Pharmaleads in major international journals:
Roques B.P., Fournié-Zaluski M.C., Wurm M. Inhibiting the breakdown of endogenous opioids and cannabinoids to alleviate pain. Nature Rev. Drug Discov., 2012, 11, 292-310.
Poras H., Bonnard E., Dangé E., Fournie-Zaluski M-C., Roques B.P. New orally active dual enkephalinase inhibitors (DENKIs) for central and peripheral pain treatment. J. Med. Chem., 2014, 57, 5748-5763.
Bonnard E., Poras H., Nadal X., Maldonado R., Fournie-Zaluski M-C., Roques B.P. Long lasting oral analgesic effects of N-Protected aminophosphinic dual enkephalinase inhibitors (DENKIs) in peripherally-controlled pain. Pharma. Res. Per., 2015, 3(2), e00116, doi: 10.1002/prp2.116

Contacts

Pharmaleads Contacts
Thierry Bourbié
CEO
thierry.bourbie@pharmaleads.com
or
Michel Wurm, MD
Development Director
Michel.wurm@pharmaleads.com
+33 (0) 1 44 06 70 00
or
Press Contact: NewCap Media
Annie-Florence Loyer, +33 (0) 1 44 72 00 12
+33 (0)6 88 20 35 59
afloyer@newcap.fr
or
Nadège Le Lezec, +33 (1) 44 71 94 93
nlelezec@newcap.fr

Contacts

Pharmaleads Contacts
Thierry Bourbié
CEO
thierry.bourbie@pharmaleads.com
or
Michel Wurm, MD
Development Director
Michel.wurm@pharmaleads.com
+33 (0) 1 44 06 70 00
or
Press Contact: NewCap Media
Annie-Florence Loyer, +33 (0) 1 44 72 00 12
+33 (0)6 88 20 35 59
afloyer@newcap.fr
or
Nadège Le Lezec, +33 (1) 44 71 94 93
nlelezec@newcap.fr