Navigation Links
Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403

BOTHELL, Wash., May 7, 2012 /PRNewswire/ -- Alder BioPharmaceuticals Inc. today announced the initiation of a Phase 1 clinical study of its antibody therapeutic candidate, ALD403, targeting the calcitonin gene-related peptide (CGRP) for treatment of migraine.

The placebo-controlled, single ascending-dose study will evaluate the safety and tolerability of ALD403 administered via both intravenous infusion and subcutaneous injection. Healthy volunteers will be enrolled in the study and followed for 12 weeks following the treatment. In addition to the primary endpoints of safety and tolerability of the two formulations of ALD403, the study will also evaluate the pharmacokinetic and pharmacodynamic profiles of the treatment in the healthy volunteers.

"There is a significant need in patients who experience migraines on a routine basis to have a convenient treatment that can prevent the migraine before it starts," said Randall Schatzman, Ph.D., president and chief executive officer of Alder BioPharmaceuticals. "We see distinct promise in ALD403 to meet this need given its potency and specificity for CGRP, which has been established as a validated target in migraine. ALD403 is manufactured with our Mab Xpress technology which allows us to mass produce the antibody for large markets, such as migraine and to rapidly achieve proof of concept.

Research has shown that CGRP has a role as a trigger for migraine attacks, and inhibiting the peptide has demonstrated promise in preventing the onset of migraines. ALD403 is expected to be developed for patients experiencing multiple migraines per month with self-administered infrequent dosing.

Alder's core technology enables the production of antibodies in very high quantities with improved cost structure via their Mab Xpress technology, allowing this class of therapeutics to enter disease areas that have previously been inaccessible for antibodies, such as migraine and cardiovascular disease. Proof of concept for this technology was achieved with ALD518, a monoclonal antibody to the pro-inflammatory cytokine IL-6, which is currently under Phase 2 development by Bristol-Myers Squibb for autoimmune diseases (BMS-945429), while Alder is developing the antibody for cancer-related conditions.

About Alder BioPharmaceuticals

Alder BioPharmaceuticals Inc. uniquely identifies, develops and manufactures novel antibody therapeutics to alleviate human suffering in cancer, pain, cardiovascular and autoimmune and inflammatory disease areas. The company's investigational monoclonal antibody for migraine, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is now in clinical trials. ALD518 is Alder's investigational monoclonal antibody to the pro-inflammatory cytokine IL-6. Alder is developing ALD518 in Phase 2 clinical studies in multiple cancer-related conditions, while Bristol-Myers Squibb is investigating the asset (as BMS-945429) in a Phase 2b clinical study in rheumatoid arthritis and other autoimmune indications based on a 2009 partnership. Alder's management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics and enabling partners through the out-licensing of its technologies. For more information, visit

Media Contact: 
Ian Stone or David Schull
Russo Partners
Tel: +1 619-528-2220


SOURCE Alder BioPharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Alder Biopharmaceuticals to Receive $15 Million Milestone Payment from Bristol-Myers Squibb for Initiation of Phase 2b Clinical Trial in Rheumatoid Arthritis of ALD518/BMS-945429 Antibody Therapeutic Against IL-6
2. Data from Phase 2 Study of Alder Biopharmaceuticals Anti-IL-6 Antibody Therapeutic, ALD518, Demonstrate Reversal of Anemia in Patients with Advanced Non-Small Cell Lung Cancer
3. Alder Biopharmaceuticals Appoints Bruce Montgomery to Board of Directors
4. FierceBiotech Designates Alder Biopharmaceuticals One of Top Private Biotechs, Member of the 2010 Fierce 15
5. Perrigo Confirms Filing for Clobetasol Shampoo and Announcement of Patent Infringement Lawsuit by Galderma
6. Herbruck Alder to Convene Summit on the New Healthcare Reform Law
7. Galderma Received FDA Approval of Differin(R) (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation
8. Perrigo Confirms Filing for Generic Version of Clobex(R) Spray and Announcement of Lawsuit by Galderma and Dermalogix
9. Galderma Announces Interim Data Relating to Sequential Treatment Regimen of Clobex(R) Spray Followed by Vectical(TM) Ointment in Managing Plaque Psoriasis
10. Foamix and Galderma to Develop Medicated Foam for Certain Skin Diseases
11. FreshFx Recognized for use in the Scalder as a Solution to the Yield/Pathogen Reduction Dilemma
Post Your Comments:
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/26/2016)... Charlotte, NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind ... able to be personalized through a fitness app. The fitness app plans to fix the ... solutions currently only offer a one size fits all type program , They ...
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
(Date:6/25/2016)... , ... June 25, 2016 , ... First Choice ... States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm ... Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical ...
(Date:6/25/2016)... ... 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the ... to iHire in recognition of their exemplary accomplishments in worksite health promotion. , The ... Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
Breaking Medicine News(10 mins):