Trial Results Validate New Drug-Delivering Nasal Implant
Source: Matthew Caufield
September 21, 2023 (Investorideas.com Newswire) This product candidate presents a compelling approach to treating post-surgery chronic rhinosinusitis patients, noted an H.C. Wainwright & Co. report.
Lyra Therapeutics Inc. (LYRA:NASDAQ) announced positive topline clinical trial data on its second product candidate LYR-220, reported H.C. Wainwright & Co. analyst Matthew Caufield in a September 12 research note. LYR-220 is a nasal implant designed to deliver medicine directly to the sinonasal tissues, as conventional therapies cannot do so, in patients with chronic rhinosinusitis (CRS).
LYR-220, delivering the corticosteroid, mometasone furoate, on a long-acting basis, is being evaluated in CRS patients with postsurgical anatomy in the Phase 2 BEACON trial. Lyra's similar lead product candidate, LYR-210, is being assessed in surgically naïve CRS patients in the Phase 3 ENLIGHTEN study.
"Ultimately, we view the platform as potentially treating the range of CRS disease, whether nasal anatomy is surgically naïve or post-surgical and with durable six-month anti-inflammatory delivery," Caufield commented.
Current management of CRS patients includes saline rinses, topical nasal steroids, oral steroids, and, sometimes, repeated nasal surgeries. Caufield pointed out there is no approved, on-label therapy for about 80% of the 8 million treated, polyp-free CRS patients in the U.S.
Compelling Potential Gain
Given the positive Phase 2 BEACON trial update, H.C. Wainwright reiterated its target price on Lyra of US$12 per share, noted Caufield. In comparison, the biotech's current price is about US$4.28 per share. The projected return for investors, therefore, is significant, at 180%.
Lyra is a Buy.
Interpretation of the Data
Caufield provided the main takeaways from the topline BEACON data:
1) Overall, these new results provide proof of concept and validate Lyra's nasal implant in this CRS population, patients who have had a bilateral ethmoidectomy and remain symptomatic.
2) Early and sustained improvement on the sinonasal outcome test score as early as two weeks carried forward through Week 24, "notably at almost twice the minimal clinically important difference," noted Caufield.
3) LYR-220 met the endpoint of improved 3CS composite score with a statistically significant result. This same endpoint is being evaluated in the Phase 3 ENLIGHTEN trial. Were the endpoint met in ENLIGHTEN, this would present an "opportunity for comprehensive CRS therapy," Caufield wrote.
4) Significant individual improvements shown in the study included reduced nasal blockage, nasal discharge, and facial pain and pressure.
5) Improvement could persist into the period off of treatment, and upcoming Phase 2 data through 28 weeks should shed light on this. Even in the event implants were to be replaced twice a year, purported Caufield, the improvement would still be greater than with noncurative surgeries or off-label nasal corticosteroid use.
"With the Phase 2 BEACON trial evaluating LYR-220 safety, tolerability, pharmacokinetics, and efficacy, we believe the therapeutic profile, without significant adverse events, presents a compelling approach to current postsurgical unmet need," Caufield wrote.
Treating a Range of Disease
The positive topline LYR-220 Phase 2 data bode well for Lyra's lead product candidate LYR-210 in the Phase 3 ENLIGHTEN clinical trial, in progress, wrote Caufield. Topline data from ENLIGHTEN are expected in H1/24.
"We specifically believe the Phase 3 ENLIGHTEN program is positioned for success," Caufield added.
LYR-210 could be an option for patients earlier on in treatment, and for patients not wanting ongoing nasal surgeries, Caufield pointed out. Further, insertion of a nasal implant in the office setting for durable drug release is straightforward, thereby aiding patient retention.
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