Strongbridge Biopharma plc Provides Corporate Update
~ Company Reported Positive and Statistically Significant Top-Line Results from the Pivotal Phase 3 LOGICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome; To View the Complete Earlier Announcement, Visit the Company’s Website ~
~ Company Anticipates Submitting a New Drug Application (NDA) for RECORLEV® (levoketoconazole) to the FDA in the First Quarter of 2021 ~
~ Reports Unaudited KEVEYIS® (dichlorphenamide) July and
~ Given Continued Strong Performance, Company is Increasing KEVEYIS® (dichlorphenamide) Full-Year Revenue Guidance for 2020 to
~ Positive Top-Line Results from the LOGICS Study Provides the Option to Draw an Additional
~ Company to Host Conference Call Today at 8:30 a.m. ET ~
“The reporting of positive and statistically significant top-line results earlier today from the Phase 3 LOGICS study of RECORLEV® (levoketoconazole) is a significant achievement for Strongbridge. If approved, we believe that RECORLEV has the potential to be a
Corporate and Financial Highlights:
Rare Endocrine Franchise: RECORLEV® (levoketoconazole)
- To view Strongbridge’s complete announcement earlier today regarding the Phase 3 LOGICS top-line study results, please visit the Company’s website at: https://investors.strongbridgebio.com/press-releases.
- Earlier today, Strongbridge reported positive and highly statistically significant top-line results from the Phase 3 LOGICS study, which met its primary endpoint. At the end of the randomized-withdrawal phase of the LOGICS study, 54.5 percent more patients who were withdrawn to placebo had a loss of prior-established mean urinary free cortisol (mUFC) response as compared with those who remained on RECORLEV (95.5 percent vs 40.9 percent respectively; p=0.0002).
- Additionally, the secondary endpoint of normalization of mUFC at the end of the randomized-withdrawal phase was also highly statistically significant with 45.5 percent more patients treated with RECORLEV maintaining mUFC normalization in the active arm than the placebo arm (50.0 percent vs 4.5 percent respectively; p=0.0015).
- RECORLEV was generally well tolerated with a safety and tolerability profile comparable to the profile observed in the Phase 3 SONICS study.
- The Company continues to anticipate that it will submit a New Drug Application (NDA) for RECORLEV to the U.S. Food & Drug Administration in the first quarter of 2021; with a 10-month PDUFA review cycle, and if approved, the launch of RECORLEV is anticipated in the first quarter of 2022.
Rare Neuromuscular Franchise: KEVEYIS® (dichlorphenamide)
- Strongbridge reports unaudited KEVEYIS® July and
August 2020combined revenue of approximately $5.5 million, resulting in 2020 year-to-date unaudited revenue of approximately $20 million, which is a 39 percent increase over revenue of $14.4 millionfor the January through August period in 2019.
- The Company increased KEVEYIS full-year revenue guidance for 2020 to
$28 millionto $29 millionfrom $22 millionto $26 million.
- Strongbridge had approximately $60 million of cash, cash equivalents and marketable securities and had drawn
$10million in debt under its existing debt facility as of June 30, 2020.
- The positive results achieved for the LOGICS study provide the Company with the option to draw an additional
$10 millionfrom the existing debt facility in the fourth quarter of 2020; and upon FDA approval of RECORLEV, an additional $10 millionwould potentially become available under the facility.
- Assuming the availability and full draw-down of the remaining
$20 millionfrom the debt facility, along with cash on-hand, the Company expects that it can fund its operations through the first quarter of 2022.
- Management plans to present at two upcoming virtual investor healthcare conferences:
° Cantor Fitzgerald Healthcare Team’s
Virtual Global Healthcare Conferenceon Tuesday, September 15, 8:40 – 9:10 a.m. EDT
• To view the Company’s presentation visit: https://www.cantor.com/global-healthcare-2020/
H.C. Wainwright& Co’s Annual Global Investment Conferenceon Wednesday, September 16, 9:00 – 9:20 a.m. EDT
• To view the Company’s presentation visit: https://hcwevents.com
Conference Call Details
Strongbridge will host a conference call on
KEVEYIS® (dichlorphenamide) is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away. You are encouraged to report side effects to
RECORLEV® (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing’s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV has demonstrated in two successful Phase 3 studies to significantly suppress serum cortisol and has the potential to be a next-generation cortisol inhibitor.
The Phase 3 program for RECORLEV includes SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The LOGICS study, which met its primary endpoint, is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS. The ongoing long-term open label OPTICS study will gather further useful information related to the long-term use of RECORLEV.
RECORLEV has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.
This press release contains forward-looking statements within the meaning of the federal securities laws. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to KEVEYIS revenue through
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Source: Strongbridge Biopharma plc