Chiasma Announces Positive Phase 3 Top-Line Results from CHIASMA OPTIMAL Clinical Trial of Mycapssa® for the Maintenance Treatment of Adults with Acromegaly
SPA-agreed trial met primary and all secondary endpoints
No new or unexpected safety signals in the Mycapssa treated patients
90% of the patients treated with Mycapssa who completed the 36-week study opted to continue into the Open Label Extension
Company to host conference call today at
In the CHIASMA OPTIMAL trial, a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules conducted under special protocol assessment, or SPA, agreement with the
- The primary endpoint was met:58% of the patients on octreotide capsules maintained their IGF-1 response compared to 19% of the patients on placebo (p = 0.008).
- All secondary endpoints were met.
“We are pleased with the positive results from the CHIASMA OPTIMAL trial and we believe this brings us one step closer to making the first oral somatostatin analog (SSA) product candidate available to adults suffering from acromegaly,” said Raj Kannan, Chief Executive Officer of Chiasma. “We plan to submit an NDA by the end of the year with an expected six-month PDUFA review time period.”
“I am excited that the CHIASMA OPTIMAL study met the primary and all secondary endpoints,” commented
Mycapssa® Secondary Efficacy Data:
- 78% of patients treated with octreotide capsules maintained their growth hormone (GH) levels below 2.5 ng/mL at the end of the core study vs. 30% of patients treated with placebo (p = 0.001)
- Median time to loss of response (IGF-1 >1.0 × ULN) was not reached (>36 weeks) for patients treated with octreotide capsules vs. 16 weeks for patients treated with placebo (p <0.001)
- Median time to loss of response (IGF-1 ≥ 1.3 × ULN) was not reached (>36 weeks) for patients treated with octreotide capsules vs. 16 weeks for patients treated with placebo (p <0.001)
- 25% of patients treated with octreotide capsules required rescue medication with injectable SSAs (octreotide LAR or lanreotide depot) anytime throughout the study vs. 68% of patients treated with placebo (p =0.003)
Additionally, in a pre-specified exploratory endpoint, mean IGF-1 values across all patients treated with octreotide capsules (including primary endpoint non-responders per protocol), remained within normal limits (≤ 1.0 x ULN) up to the end of oral treatment. For purposes of this analysis, the end of oral treatment value was the average of week 34 and week 36 values for all patients who completed the study on octreotide capsules and for those patients that required rescue medication, it was their last observed value prior to the use of rescue medication.
Mycapssa® Safety and Tolerability:
In the CHIASMA OPTIMAL trial, octreotide capsules appeared safe and well tolerated. No new or unexpected safety signals were observed. The overall number of treatment emergent adverse events (TEAEs) was comparable between the octreotide capsules and placebo treatment groups. Two patients on octreotide capsules and one patient on placebo discontinued treatment due to TEAEs. Two patients on octreotide capsules and one patient on placebo had serious adverse events, or SAEs, assessed as not related to study drug. Severe TEAEs as well as TEAEs of special interest (acromegaly symptoms) were more common in placebo treated patients than in patients treated with octreotide capsules.
“We are pleased to have successfully completed the CHIASMA OPTIMAL trial under a SPA agreement with the FDA. The
CHIASMA OPTIMAL Trial Design
The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules that was conducted under a special protocol assessment, or SPA, agreement with the
Regulatory and Financial Update
Chiasma plans to submit a New Drug Application (NDA) by the end of the year for octreotide capsules for the maintenance treatment of adults with acromegaly. The CHIASMA OPTIMAL trial was conducted under a SPA agreement with the
The Company ended
Conference Call and Webcast Information:
Chiasma management will host a conference call and webcast to discuss the CHIASMA OPTIMAL results in more detail today,
The dial-in number in the U.S./
To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=135476
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much GH, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. We believe that approximately 8,000 adult acromegaly patients are chronically treated with SSAs in
Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. In
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the CHIASMA OPTIMAL trial and whether the data will support the submission of an NDA for octreotide capsules and ultimately regulatory approval, statements regarding the timing of NDA submission and regulatory review, including the company’s anticipated eligibility for a six-month PDUFA review cycle, statements concerning the nature of the FDA’s review of any such NDA submission and whether the data submission will be sufficient to support regulatory approval, and statements regarding the number of adult acromegaly patients chronically treated with SSAs in
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Source: Chiasma, Inc.