ALDR >up 22% on pipeline update...
Alder BioPharmaceuticals Reports First Quarter 2015 Financial and Operating Results
Alder Provides Update on Clinical Development Plan for ALD403 in Migraine Prevention
BOTHELL, Wash., May 7, 2015 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. ("Alder") (ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, Cushing's disease and autoimmune and inflammatory diseases, today provided recent corporate highlights and reported its financial results for the first quarter ended March 31, 2015.
"We are continuing our focus on expediting the development of ALD403 to treat migraine patients, and today we are outlining our clinical development plan for this promising compound with the goal of bringing both infusion and self-administered formulations to patients," said Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder. "We believe ALD403 has the potential to transform the way physicians treat migraine prevention by providing an agent with a previously demonstrated ability to deliver rapid onset, 100% migraine prevention in 27 to 41% of patients in any month and long lasting efficacy; we see this as a very significant market opportunity. We remain on track to report primary endpoint data from our ongoing Phase 2b trial in chronic migraine sufferers in the second half of the year and plan to initiate pivotal studies of ALD403 this year as well.
"During the first quarter we fortified our financial position through an equity offering, raising more than $190 million to support both the aggressive development of ALD403, as well as other promising product candidates in our pipeline, such as ALD1613 for Cushing's disease," continued Dr. Schatzman.
Recent Pipeline and Corporate Highlights
Clinical development plans of ALD403 for both infusion and self-administration formulations. ALD403 is Alder's transformative novel monoclonal antibody that targets calcitonin gene-related peptide, or CGRP, and is being developed for the prevention of migraine. In addition to the ongoing 600 patient Phase 2b double-blind, randomized, placebo-controlled dose-ranging clinical trial in chronic migraine sufferers, Alder has initiated or plans to initiate the following studies during 2015:
An 800 to 1000 patient double-blind, placebo-controlled, randomized, dose-ranging clinical trial utilizing an intravenous (IV) formulation of ALD403 administered quarterly for the treatment of both chronic and frequent episodic migraine, which is defined as those patients suffering from five or more migraine days each month. Alder expects this trial to be a pivotal trial. This trial is expected to commence early in the second half of 2015 and the primary endpoint will be the change in migraine days between ALD403 and placebo as determined by responder rates over a 12-week period.
An ongoing placebo-controlled Phase I study in healthy volunteers investigating different dose levels of ALD403 formulated for self-administration. The goal is to identify a dose that delivers the rapidity of onset, and durability of effect previously seen with intravenous administration and enables once per quarter administration. Alder expects to report top-line data from this study in the second half of 2015.
Following this data result, Alder plans to initiate a previously described trial, in 240 patients to determine a dose of ALD403 that can deliver efficacy via self-administration over a full 12-week period. This will be a double-blind, placebo-controlled, randomized, multi-dose, dose-ranging clinical trial utilizing ALD403 formulated for quarterly dosing in frequent episodic migraine patients, which is defined as those patients suffering five to 14 migraine days per month. This trial is expected to commence in the second half of 2015 with top-line data anticipated in the second half of 2016. The primary endpoint of the trial will be the change in migraine days between ALD403 and placebo as determined by responder rates over a 12 week period.
At the end of 2015 Alder expects to have three ongoing large clinical trials of ALD403 aimed at treating more than 1,500 migraine patients.
Clazakizumab met its primary endpoint in follow-on Phase 2b trial in rheumatoid arthritis (RA).
Alder announced on May 5 that the primary endpoint was met in a 140 patient follow-on Phase 2b, dose-ranging clinical trial designed to determine the safety and efficacy of clazakizumab in RA patients who are anti-TNF inadequate responders. Alder will present full data at a future rheumatology society meeting.
Alder continues to seek a partner to collaborate in the development and commercialization of clazakizumab.
Corporate Updates
In January 2015, Alder completed a follow-on offering with net proceeds of approximately $190.7 million. The offering consisted of an aggregate of 6,900,000 shares at a public offering price of $29.50 per share, before underwriting discounts and commissions and offering expenses.
Anticipated Upcoming Milestones
Announce primary endpoint data for ALD403 Phase 2b trial in chronic migraine in 2H, 2015: Alder plans to announce primary endpoint data from its 600-patient Phase 2b double-blind, randomized, placebo-controlled dose-ranging clinical trial utilizing IV formulation of ALD403 for the preventative treatment of chronic migraine sufferers in the second half of 2015. The primary endpoint of this Phase 2b trial is the change in migraine days between ALD403 and placebo as judged by the difference in the responder rates over a 12-week period.
Announce primary endpoint data from a Phase I trial of ALD403 formulated for quarterly self-administration in the second half of 2015. Alder plans to announce primary endpoint data from its placebo-controlled Phase 1 study in healthy volunteers investigating different dose levels of ALD403 formulated for quarterly self-administration in the second half of 2015.
Initiate pivotal trials for ALD403 in the second half of 2015: As noted above, in the second half of 2015, Alder plans to initiate a pivotal double-blind, placebo-controlled, randomized, dose-ranging clinical trials utilizing an IV formulation of ALD403 administered quarterly for the treatment of both chronic and frequent episodic migraine. The primary endpoint is the same as the Phase 2b trial in chronic migraine.
Initiate a Phase 2b dose-ranging trial of ALD403 formulated for self-administration in the second half of 2015: Alder plans to initiate a double-blind, placebo-controlled, randomized, dose-ranging clinical trial of ALD403 formulated for quarterly self-administration in frequent episodic migraine patients in the second half of 2015. The primary endpoint is the same as the Phase 2b trial in chronic migraine.
Initiate Phase 1 trial for ALD1613 in Cushing's disease: Alder plans to advance ALD1613 through Investigational New Drug (IND)-enabling toxicology studies in 2015 and commence a Phase 1 trial in 2016 for the treatment of Cushing's disease, an orphan disease driven by long-term exposure to cortisol as a result of increased expression of adrenocorticotropic hormone (ACTH) produced by a pituitary tumor.
Upcoming Data Presentations
Alder will present data for ALD403 at the 17th Congress of the International Headache Society on Friday, May 15, in Valencia, Spain:
Oral presentation: "Proof of Concept Clinical Trial of ALD403, an Anti-Calcitonin Gene-Related Peptide (CGRP) Antibody in the Prevention of Migraine -- 6 Month Data"
Poster presentation: "PK & PD Supporting A Single Dose, Placebo-Controlled Randomized Ascending Dose Study of ALD403, a Humanized anti-Calcitonin Gene-Related Peptide (CGRP) Monoclonal Antibody Administered IV or SC"
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