Three Companies and What They’re Working On
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BY: Lisa Munger
The biotech sector has experienced a surge in venture capital (VC) funding in recent years, providing a boost to fertility-related research and development, according to a report by analysts at McKinsey & Company.
In 2016, VC companies invested in 2,200 biotech start-ups worldwide, growing to 3,100 by 2021. These investments have contributed to developing next-gen biopharmas and biotechs actively working on fertility innovations.
PIPELINE HIGHLIGHTS
Granata Bio
Founder Evan Sussman said he started Granata Bio five years ago because he saw an unmet need in the field. Before that, he spent 10 years at EMD Serono. He said there was more bandwidth for drug development in the U.S. and hoped Granata would help fill the gap.
Now, the company is focused on a pipeline intended to minimize market monopolies and bring new therapeutics to market.
“We hope to bring clomiphene citrate back to the market by the end of the year,” Sussman said. “That product is symbolic of what's going on in women's health generally. There's a paucity of available drugs. Clomiphene is a 50-year-old class of drugs, but there's only one commercialized product, and the price has gone up significantly in the last year or two years because there's no competition.”
Also in Granata’s pipeline development: subcutaneous progesterone, menotropins for injection and a commercially-available ganirelix acetate injection.
Oral Allosteric Agonists Show Promise in Preclinical Studies
High-complexity methods like controlled ovarian stimulation - in vitro fertilization (IVF) or low-complexity methods like ovulation induction - intrauterine insemination (IUI) for treatment. In preclinical studies, researchers discovered that two oral follicle-stimulating hormone receptor allosteric agonist compounds, TOP5668 and TOP5300, have pharmacology, drug metabolism, pharmacokinetics and safety profiles suitable for clinical use.
While more testing is necessary before clinical use, these results provide avenues for infertility treatment. If clinical trials prove successful, these oral follicle-stimulating hormone receptor allosteric agonists could offer a more convenient and efficient single-agent treatment for infertility patients than existing therapeutic approaches.
Celmatix
Celmatix announced a development in their pipeline - an oral follicle-stimulating hormone (FSH) candidate. This treatment can potentially shift fertility care and allow individuals more options other than traditional injections associated with IVF.
Celmatix's oral FSH candidate aims to unlock a more convenient and accessible fertility treatment option for patients.
“Our goal is to eliminate the need for injections during ovarian stimulation ahead of egg freezing and IVF procedures,” said Dr. Piraye Yurttas Beim, founder and CEO of Celmatix. “We also want to reduce the need for women to undergo IVF procedures in the first place by both providing a more effective strategy for restoring ovulatory function in women with ovarian conditions like polycystic ovary syndrome (PCOS) and addressing the significant burden that male infertility places on couples by also advancing our program to help men increase their sperm count and viability.”
While Celmatix's oral FSH candidate shows some promise, Sussman said, he said any oral application is likely 10 years from the market. Further research, clinical trials and regulatory approvals are necessary to validate its safety and efficacy.
While an oral therapeutic may appeal to some and enhance tolerability, Sussman said it’s Celmatix’s “moonshot,” but other companies are focused elsewhere. Specifically, he pointed to targeting poor ovarian response and diminished ovarian reserve patients- as one of the industry’s moonshots.
Oviva Therapeutics
A biotech startup called Oviva Therapeutics has emerged to develop drugs to prolong fertility and delay menopause. This approach could affect women's reproductive health and overall well-being. Sussman pointed to Oviva’s work as “one to watch.”
Led by Dr. Patricia K. Donahoe, director of Pediatric Surgical Research Laboratories at Massachusetts General Hospital, Oviva Therapeutics is focused on harnessing the potential of a little-studied hormone to achieve these revolutionary goals. Dr. Donahoe said that the hormone, or drugs that mimic its effects, could slow down or even halt the natural loss of eggs that women experience every month. This ability to preserve eggs could extend a woman's fertility and potentially delay the onset of menopause.
Oviva Therapeutics plans to test its AMH-based therapies in the clinic, starting with using AMH to aid women struggling to conceive through IVF. This initial step will serve as a platform for broader indications and applications.
The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser
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