756
REFERENCES 1. Jääskeläinen SK. Pathophysiology of primary burning mouth syndrome. Clin Neurophysiol. 2012;123:71-77. 2. Henkin RI, Gouliouk V, Fordyce A. Distinguishing patients with glossopyrosis from those with oropyrosis based upon clinical differences and differences in saliva and erythrocyte magnesium. Arch Oral Biol. 2012;57:205-210. 3. Cho GS, Han MW, Lee B, et al. Zinc deficiency may be a cause of burning mouth syndrome as zinc replacement therapy has therapeutic effects. J Oral Pathol Med. 2010; 39:722-727. 4. López-Jornet P, Camacho-Alonso F, Andujar-Mateo P, Sánchez-Siles M, Gómez-Garcia F. Burning mouth syndrome: Update. Med Oral Patol Oral Cir Bucal. 2010;15: 562-568. 5. Friedman DI. Topiramate-induced burning mouth syndrome. Headache. 2010;50:1383-1385.
Clinical Trials Update – 2013: Year in Review As in previous years, the January 2014 issue of the Headache Journal published a very complete review of the ongoing migraine pipeline by Dr. Peroutka.1 Once more the article is a reference for all of those working in research and development in the field of headaches. One of the compounds reviewed by Dr. Peroutka is LBR-101, which is a fully humanized monoclonal antibody that targets CGRP. LBR-101 is being developed by Labrys Biologics for the preventive treatment of chronic migraine and high frequency episodic migraine. Following the publication of Dr. Peroutka’s extensive review, several noteworthy developments have occurred regarding LBR-101, and we wish to provide an update of its status. Dr. Peroutka correctly states that Labrys had announced plans to start Phase 2 with a subcutaneous formulation, instead of an intravenous formulation that had been used during Phase 1.2 This switch to a more convenient route of administration was based upon the pharmacokinetic results of a dedicated Phase 1 bridging study. In addition, the company made a strategic decision to investigate LBR-101 in all patients who require migraine prevention by initiating separate Phase 2B studies in chronic migraine and high frequency episodic migraine. Details for each of Conflict of Interest: Dr. Bigal is a full-time employee of Labrys Biologics.
April 2014 the three studies are described in clinicaltrial.gov.3-5 Each Phase 2B study is a multicenter, randomized, double-blind, placebo-controlled, parallel design study involving the investigation of multiple doses of LBR-101. LBR-101 is given once monthly by subcutaneous injection for a total of three months (in addition to one month of baseline prospective assessment). As disclosed in clinicaltrials.gov, the high frequency episodic migraine study is enrolling patients with headaches from 8-14 days per month. A total of 270 patients will be enrolled. The estimated completion date for top-line results is January 2015. The chronic migraine study will enroll 240-250 patients with an estimated completion date for primary analysis of February 2015. Altogether, the studies will investigate four different treatment paradigms to properly inform the subsequent Phase 3 program. Extensive manufacturing activities are being conducted in parallel in order to enable Phase 3 initiation as soon as authorized by regulators, assuming positive Phase 2B data. Since the information was released at the very end of 2013 and is substantial, we feel that this letter is relevant. LBR-101 is currently being investigated in a dual Phase 2 development, for high frequency episodic and for chronic migraine. Marcelo E. Bigal, MD, PhD Chief Medical Officer Labrys Biologics, Inc., Doylestown, PA, USA
REFERENCES 1. Peroutka SJ. Clinical trials update. 2013: Year in review. Headache. 2014;54:189-194. 2. Bigal ME, Escandon R, Bronson M, et al. Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: Results of the Phase 1 program. Cephalalgia. 2013; Dec 23 [Epub ahead of
print]. 3. Bigal ME, Escandon R. Safety and Bioavailability of IV and SC LBR-101. 2013 [cited January 21, 2014]; Available from:
http://clinicaltrial.gov/ct2/show/NCT01991509?term=LBR101&rank=2. 4. Bigal M, Escandon R. Assessment of LBR-101 in Chronic Migraine. 2013 [cited January 20, 2014]; Available from:
http://clinicaltrial.gov/ct2/show/NCT02021773?term=LBR101&rank=3. 5. Bigal M, Escandon R. A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine. 2013 [cited January
20, 2014]; Available from: http://clinicaltrial.gov/ct2/show/ NCT02025556?term=LBR-101&rank=1.
REFERENCES 1. Jääskeläinen SK. Pathophysiology of primary burning mouth syndrome. Clin Neurophysiol. 2012;123:71-77. 2. Henkin RI, Gouliouk V, Fordyce A. Distinguishing patients with glossopyrosis from those with oropyrosis based upon clinical differences and differences in saliva and erythrocyte magnesium. Arch Oral Biol. 2012;57:205-210. 3. Cho GS, Han MW, Lee B, et al. Zinc deficiency may be a cause of burning mouth syndrome as zinc replacement therapy has therapeutic effects. J Oral Pathol Med. 2010; 39:722-727. 4. López-Jornet P, Camacho-Alonso F, Andujar-Mateo P, Sánchez-Siles M, Gómez-Garcia F. Burning mouth syndrome: Update. Med Oral Patol Oral Cir Bucal. 2010;15: 562-568. 5. Friedman DI. Topiramate-induced burning mouth syndrome. Headache. 2010;50:1383-1385.
Clinical Trials Update – 2013: Year in Review As in previous years, the January 2014 issue of the Headache Journal published a very complete review of the ongoing migraine pipeline by Dr. Peroutka.1 Once more the article is a reference for all of those working in research and development in the field of headaches. One of the compounds reviewed by Dr. Peroutka is LBR-101, which is a fully humanized monoclonal antibody that targets CGRP. LBR-101 is being developed by Labrys Biologics for the preventive treatment of chronic migraine and high frequency episodic migraine. Following the publication of Dr. Peroutka’s extensive review, several noteworthy developments have occurred regarding LBR-101, and we wish to provide an update of its status. Dr. Peroutka correctly states that Labrys had announced plans to start Phase 2 with a subcutaneous formulation, instead of an intravenous formulation that had been used during Phase 1.2 This switch to a more convenient route of administration was based upon the pharmacokinetic results of a dedicated Phase 1 bridging study. In addition, the company made a strategic decision to investigate LBR-101 in all patients who require migraine prevention by initiating separate Phase 2B studies in chronic migraine and high frequency episodic migraine. Details for each of Conflict of Interest: Dr. Bigal is a full-time employee of Labrys Biologics.
April 2014 the three studies are described in clinicaltrial.gov.3-5 Each Phase 2B study is a multicenter, randomized, double-blind, placebo-controlled, parallel design study involving the investigation of multiple doses of LBR-101. LBR-101 is given once monthly by subcutaneous injection for a total of three months (in addition to one month of baseline prospective assessment). As disclosed in clinicaltrials.gov, the high frequency episodic migraine study is enrolling patients with headaches from 8-14 days per month. A total of 270 patients will be enrolled. The estimated completion date for top-line results is January 2015. The chronic migraine study will enroll 240-250 patients with an estimated completion date for primary analysis of February 2015. Altogether, the studies will investigate four different treatment paradigms to properly inform the subsequent Phase 3 program. Extensive manufacturing activities are being conducted in parallel in order to enable Phase 3 initiation as soon as authorized by regulators, assuming positive Phase 2B data. Since the information was released at the very end of 2013 and is substantial, we feel that this letter is relevant. LBR-101 is currently being investigated in a dual Phase 2 development, for high frequency episodic and for chronic migraine. Marcelo E. Bigal, MD, PhD Chief Medical Officer Labrys Biologics, Inc., Doylestown, PA, USA
REFERENCES 1. Peroutka SJ. Clinical trials update. 2013: Year in review. Headache. 2014;54:189-194. 2. Bigal ME, Escandon R, Bronson M, et al. Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: Results of the Phase 1 program. Cephalalgia. 2013; Dec 23 [Epub ahead of
print]. 3. Bigal ME, Escandon R. Safety and Bioavailability of IV and SC LBR-101. 2013 [cited January 21, 2014]; Available from:
http://clinicaltrial.gov/ct2/show/NCT01991509?term=LBR101&rank=2. 4. Bigal M, Escandon R. Assessment of LBR-101 in Chronic Migraine. 2013 [cited January 20, 2014]; Available from:
http://clinicaltrial.gov/ct2/show/NCT02021773?term=LBR101&rank=3. 5. Bigal M, Escandon R. A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine. 2013 [cited January
20, 2014]; Available from: http://clinicaltrial.gov/ct2/show/ NCT02025556?term=LBR-101&rank=1.
