The state of longevity – 2021’s Who’s Who in age-related clinical trials

Longevity.Technology’s diamond dozen – 12 companies who progressed their therapeutics in longevity clinical trials and contributed to 2021’s drive in age-related research.

We have been engaged in a full review of the state of longevity over the past year; earlier this week we shared our review of longevity clinical trials and our analysis of exactly how the longevity clinical trial market performed last year.

2021 has been a fast-paced year for the longevity clinical trials market; to give a flavour of this pace, we’ve spotlighted the 12 companies who this year have been contributing to the drive in age-related research as they have been progressing their therapeutics throughout 2021.

As well as noting their longevity drug candidates and what clinical trial phase they have reached in 2021, we overview what aspect of longevity each company centres around and summarise the outcomes of each phase. And, of course, we dive into what we can expect to see from the companies in 2022 – and beyond.

Longevity clinical trials targeting macular degeneration, neurodegeneration, obesity

Unity Biotechnology has been diving into longevity through senotherapeutics, targeting age-related macular degeneration (AMD) and diabetic macular edema (DME). Its phase 1 longevity clinical trial results proved its UBX1325 therapy safe. It showed structural improvements in the central subfield thickness, and sub- and intra-retinal fluid leading to an improvement in overall vision. Unity is also currently evaluating the safety and efficacy of UBX1325 in patients with diabetic macular edema.

Bioviva has made way in 2021 with both the Telomerase Reverse Transcriptase (hTERT) and Klotho gene transfer therapies making their way out of phase 1 trials. The two therapeutics are set to treat dementia in a bid to aid cognition longevity. The longevity clinical trial showed that median telomere length lengthened in 4 out of 5 patients. In addition, the shortest telomeres showed significant elongation in all 5 patients. Biological age was significantly reduced in 4 out of 5 patients. The study was a success with significant cognitive testing improvement in all 5 patients. Bioviva aims to conduct follow up studies with larger sample sizes.

CohBar, a company targeting mitochondria, one of the hallmarks of aging, has finished both its phase 1a and 1b studies into CB4211. CohBar’s therapeutic intervention targets obesity and non-alcoholic steatohepatitis (NASH), and it has been proven safe in its recent trial phase. The therapy used led to a reduction in glucose, leading towards body weight reduction. CohBar are currently collating data for analysis, allowing the company to prepare for future work.

Denali has been working towards therapy creation for neurodegenerative disorders, focusing on Parkinson’s Disease. During phase 1b trials, treatment using BIIB122 and DNL151 achieved reductions in the biomarkers of target engagement and pathway engagement seen in both healthy volunteers and patients with Parkinson’s disease. BIIB122/DNL151 demonstrated a safety profile supporting continued development in patients with Parkinson’s disease.

Trials targeting frailty, sarcopenia, macular degeneration

Scholar Rock is coming out of a phase 2 trial of SRK-015/Apitegromab targeting frailty and age-related decline. The therapeutic has been developed for spinal muscular atrophy (SMA), to alleviate symptoms associated with the disease.
Scholar Rock is coming out of a phase 2 trial of SRK-015/Apitegromab targeting frailty and age-related decline. The therapeutic has been developed for spinal muscular atrophy (SMA), to alleviate symptoms associated with the disease. The trial showed that the majority of patients had meaningful motor function improvements with a >1-point increase in the Hammersmith functional Motor Scale Expanded (HFMSE). Scholar Rock is currently planning a phase 3 trial to target patients with type 2 and type 3 SMA.

Biophytis’ Sarconeos (BIO101) therapy has just come out of its phase 2 trial. Biophytis has been targeting Sarcopenia and its latest study showed Sarconeos at its highest dose produced a clinically meaningful improvement in the 400-metre walk test in individuals who suffer with Sarcopenia. Sarconeos is also currently being studied in a clinical two-part phase 2-3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19.

Stealth BioTherapeutics has also seen the results of its ReCLAIM-2 therapeutic from its phase 2 study targeting age-related macular degeneration (AMD). The data showed improvements from baseline in LLVA and BCVA for patients with GA and drusen who completed the trial. Visual quality of life improvement was seen under both low light and ordinary light conditions. Currently ReCLAIM-2 study data is being gathered to inform Phase 3 trial design.

Biosplice Therapeutics, a company targeting mobility via osteoarthritis (OA), has developed Lorecivivint, a therapeutic intervention that has just finished its phase 2b trial. The Knee OA drug candidate met primary endpoints of pain NRS (daily pain management) at both 12 and 24-week timepoints. It has proven safe and well tolerated and has paved the way for its phase 3 trials, which are already underway.

Longeveron’s phase 2b study of Longeveron Mesenchymal Stem Cells (LMSCs) showed an increase in the six-minute walk test after 6 months, with patients given the highest dose of 200 million cells showing an increase in walking distance of 41 metres. Longeveron has sponsored a treatment registry trial in the Bahamas which eligible patients can take part in at their own expense, giving a glimpse into the near future use of stem cell therapy.

Trials targeting back pain, mitochondrial dysfunction, dry eye disease

Mesoblast has spent 2021 completing the phase 3 trial of candidate Rexlemestrocel-L + Hyaluronic Acid for the treatment of degenerative disc disease (DDD) and chronic back pain. The results of the study showed the treatment was safe, durable and effective as an opioid-paring therapy for chronic inflammatory back pain due to DDD. Mesoblast offers therapies to target cardiovascular disorders, spine orthopaedic disorder, oncology, haematology and inflammatory disease, showing the large reach the company has, as it is able to target multiple age-related diseases across the longevity sector.

Gensight Biologics targets mitochondrial dysfunction associated with aging. The company has finished its phase 3 trial of LUMEVOQ (GS010), a drug candidate to treat Leber hereditary optic neuropathy (LHON) and retinitis pigmentosa (RP). Results from a long term follow up from the study showed continued improvement in best-corrected visual acuity after treatment. Researchers have stated interest in using the same approach to treat other mitochondrial diseases, as well as a future aim to specifically target Geographic Atrophy in Dry-AMD.

Mitotech aims to gain a wiser understanding of aging through leading research into different age-related diseases such as: ophthalmic, neurodegenerative, autoimmune and rare mitochondrial. The company’s lead compound SkQ1 targets a biological process that has not been adequately addressed by existing ophthalmic therapies: mitochondria-specific oxidative stress. Its drug candidate VISTA-1/VISTA-2, has passed through its phase 3 trials, studying its effects when treating dry eye disease. The study revealed the candidate to have significant impact of skQ1 on clearing central corneal staining (CCFS) and improvement of best corrected visual acuity (BCVA).

Next week, we’ll check out some of the longevity companies that have emerged from stealth and see what they are planning for 2022 – stay tuned!

Read more about the state of longevity in our FREE Annual Report 2021 HERE.

Photograph: Tima Miroshnichenko/Pexels