LGVN - Upcoming Phase 2 Data Expected For Longeveron’s (NASDAQ: LGVN) Drug For the $4+ Billion Alzheimer’s Sector – What To Look For
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By David Willey, Benzinga
Longeveron (NASDAQ: LGVN), a clinical-stage biopharma developing potentialtreatments for age-related and life-threatening diseases, is expectingdata from its phase 2a trial for its Lomecel-B™ cellular drug in thenext 3 to 4 months.
Longeveron’s primary drug candidate, a cell-based medicine,is being tested for several indications, including Aging-relatedFrailty, a rare pediatric disease called hypoplastic left heartsyndrome (HLHS), and Alzheimer’s disease (AD). It is running phase 2trials for each of these conditions and expects to announce top-lineresults for the AD trial soon.
A previous clinical study indicated thatLomecel-B’s™ mechanisms of action (MoA) had the potential toaffect multipleAD markers simultaneously , such as reducing neuroinflammation,improving neural blood vessels, and decreasing the brain damage thatcomes from AD. According to Longeveron, other potential therapiesbeing tested mainly target amyloid plaques or neurofibrillary tangles.Longeveron uses medicinal signaling cells (MSCs) that may cross theblood-brain barrier (based on results from animal studies) and areprimarily aimed at downregulating inflammation, which is a pathwayassociated with AD’s neurodegeneration, including memory loss.
Longeveroncompleted a randomized, placebo-controlled phase 1 trial that testedfor safety as a primary objective, as well as potential efficacy. Thetrial saw no serious adverse events and indicated a statisticallysignificant improvement in cognition in the patients. Importantly, thetrial showed that Lomecel-B™ did not appear to cause ARIA(Alzheimer’s Related Imaging Abnormality), a serious potential sideeffect of some AD treatments.
Theseresults led to Longeveron initiatinga phase 2 trial late in 2022, a 41-week trial on 48 patientswith mild AD. The primaryobjective for the trial is safety, though the Company isexploring signals for multiple secondary endpoints, includingcognitive measures, the AD assessment scale for cognitive function(ADAS-Cog), and inflammatory biomarkers. In addition, the trial isalso designed to test whether repeat dosing of Lomecel-B™ mayproduce greater drug efficacy. The Company anticipates that if thetrial is successful and shows efficacy, there is the potential forLomecel-B™ to be developed as a disease-modifying treatment forAD.
Longeveron’s Position In An Active Market
By developingLomecel-B™ as a potential treatment for AD, Longeveron ispositioning itself for potential success in a growing sector. Withover 6million Americans suffering from AD in 2021, there is a drivein the pharmaceutical sector to develop a range of treatments for thedisease. Multiple companies are currently attempting to developtreatments, while others have received accelerated approval for theirdrugs from the FDA. The globalmarket for Alzheimer’s Disease therapies was worth $4.05billion in 2022 and is expected to grow at a compound annual growthrate (CAGR) of about 20% from 2023 to 2030 .
In 2021, BiogenInc. (NASDAQ: BIIB) received accelerated approval from the FDA forits drug Aducanumab .
AcumenPharmaceuticals (NASDAQ: ABOS) has completed a phase 1 trial forthe drug ACU193 ,and Tiziana Life Sciences (NASDAQ: TLSA) has filed aninvestigational new drug (IND) application for its drug, Foralumab ,for its AD indications.
Follow developments fromLongeveron’s cell-based therapies on itswebsite.
We are a clinical-stage biotechnologycompany developing cellular therapies for aging-related andlife-threatening conditions.Our lead investigational product isLomecel-B™, which is derived from culture-expanded medicinalsignaling cells (MSCs) that are sourced from bone marrow of younghealthy adult donors. We believe that by using the same cells thatpromote tissue repair, organ maintenance, and immune system function,we can develop safe and effective therapies for some of the mostdifficult diseases and conditions associated withaging.
Forward-Looking StatementsCertain statements inthis press release that are not historical facts are forward-lookingstatements made pursuant to the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995, which reflectmanagement's current expectations, assumptions, and estimates offuture operations, performance and economic conditions, and involverisks and uncertainties that could cause actual results to differmaterially from those anticipated by the statements made herein.Forward-looking statements are generally identifiable by the use offorward-looking terminology such as "believe,""expects," "may," "looks to," "will,""should," "plan," "intend," "oncondition," "target," "see," "potential,""estimates," "preliminary," or "anticipates"or the negative thereof or comparable terminology, or by discussion ofstrategy or goals or other future events, circumstances, or effects.Factors that could cause actual results to differ materially fromthose expressed or implied in any forward-looking statements in thisrelease include, but are not limited to, statements regarding theoffer and sale of securities, the terms of the offering, about theability of Longeveron’s clinical trials to demonstrate safety andefficacy of the Company’s product candidates, and other positiveresults; the timing and focus of the Company’s ongoing and futurepreclinical studies and clinical trials and the reporting of data fromthose studies and trials; the size of the market opportunity for theCompany’s product candidates, including its estimates of the numberof patients who suffer from the diseases being targeted; the successof competing therapies that are or may become available; thebeneficial characteristics, safety, efficacy and therapeutic effectsof the Company’s product candidates; the Company’s ability toobtain and maintain regulatory approval of its product candidates inthe U.S., Japan and other jurisdictions; the Company’s plansrelating to the further development of its product candidates,including additional disease states or indications it may pursue; theCompany’s plans and ability to obtain or protect intellectualproperty rights, including extensions of existing patent terms whereavailable and its ability to avoid infringing the intellectualproperty rights of others; the need to hire additional personnel andthe Company’s ability to attract and retain such personnel; theCompany’s estimates regarding expenses, future revenue, capitalrequirements and needs for additional financing; the Company’s needto raise additional capital, and the difficulties it may face inobtaining access to capital, and the dilutive impact it may have onits investors; the Company’s financial performance, and the periodover which it estimates its existing cash and cash equivalents will besufficient to fund its future operating expenses and capitalexpenditure requirements. Additionally, Longeveron makes no assurancethat any public offering of its securities as described herein willoccur at all, or that any such transaction will occur on thetimelines, in the manner or on the terms anticipated due to numerousfactors. Further information relating to factors that may impact theCompany's results and forward-looking statements are disclosed inthe Company's filings with the Securities and Exchange Commission,including Longeveron’s Annual Report on Form 10-K for the year endedDecember 31, 2022, filed with the SEC on March 14, 2023. Theforward-looking statements contained in this press release are made asof the date of this press release, and the Company disclaims anyintention or obligation, other than imposed by law, to update orrevise any forward-looking statements, whether as a result of newinformation, future events, or otherwise.
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